Daily valtrex dose

Daily valtrex dose DEFAULT

VALTREX - Dosage valacyclovir hydrochloride

Dosage & Administration

  • VALTREX may be given without regard to meals.
  • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500-mg VALTREX tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3)].

Adult Dosage (2.1)

Cold Sores

2 grams every 12 hours for 1 day

Genital Herpes

  Initial episode

1 gram twice daily for 10 days

  Recurrent episodes

500 mg twice daily for 3 days

  Suppressive therapy

     Immunocompetent patients

1 gram once daily

         Alternate dose in patients with less than or equal to 9 recurrences/year

500 mg once daily

     HIV-1−infected patients

500 mg twice daily

  Reduction of transmission

500 mg once daily

Herpes Zoster

1 gram 3 times daily for 7 days

Pediatric Dosage (2.2)

Cold Sores (aged greater than or equal to 12 years)

2 grams every 12 hours for 1 day

Chickenpox (aged 2 to less than 18 years)

20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily

Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg VALTREX tablets. (2.3)

adult dosing recommendations

Cold Sores (Herpes Labialis)

The recommended dosage of VALTREX for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).

Genital Herpes

Initial Episode: The recommended dosage of VALTREX for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.

Recurrent Episodes: The recommended dosage of VALTREX for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.

Suppressive Therapy: The recommended dosage of VALTREX for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily.

In HIV‑1−infected patients with a CD4+ cell count greater than or equal to 100 cells/mm3, the recommended dosage of VALTREX for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

Reduction of Transmission: The recommended dosage of VALTREX for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner.

Herpes Zoster

The recommended dosage of VALTREX for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.

pediatric dosing recommendations

Cold Sores (Herpes Labialis)

The recommended dosage of VALTREX for the treatment of cold sores in pediatric patients aged greater than or equal to 12 years is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).

Chickenpox

The recommended dosage of VALTREX for treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years is 20 mg/kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), Clinical Studies (14.4)].

extemporaneous preparation of oral suspension

Ingredients and Preparation per USP‑NF

VALTREX tablets 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL.

Instructions for Preparing Suspension at Time of Dispensing

  • Prepare SSV according to the USP-NF.
  • Using a pestle and mortar, grind the required number of VALTREX 500-mg tablets until a fine powder is produced (5 VALTREX tablets for 25-mg/mL suspension; 10 VALTREX tablets for 50-mg/mL suspension).
  • Gradually add approximately 5-mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted.
  • Continue to add approximately 5-mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25-mg/mL and 50-mg/mL suspensions.
  • Transfer the mixture to a suitable 100-mL measuring flask.
  • Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask.
  • Rinse the mortar at least 3 times with approximately 5-mL aliquots of SSV, transferring the rinsing to the measuring flask between additions.
  • Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix.
  • Transfer the suspension to an amber glass medicine bottle with a child-resistant closure.
  • The prepared suspension should be labeled with the following information “Shake well before using. Store suspension between 2° to 8°C (36° to 46°F) in a refrigerator. Discard after 28 days.”

*The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor.

patients with renal impairment

Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. Data are not available for the use of VALTREX in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m2.

Indications

Normal Dosage

Regimen

(Creatinine Clearance ≥50 mL/min)

Creatinine Clearance (mL/min)

30-49

10-29

<10

Cold sores (Herpes Labialis)

 

Do not exceed 1 day of treatment.

Two 2-gram doses taken 12 hours apart

Two 1-gram doses taken 12 hours apart

Two 500-mg doses taken 12 hours apart

500-mg single dose

Genital herpes:

 Initial episode

1 gram every 12 hours

no reduction

1 gram every 24 hours

500 mg every 24 hours

Genital herpes:

 Recurrent episode

500 mg every 12 hours

no reduction

500 mg every 24 hours

500 mg every 24 hours

Genital herpes:

 Suppressive therapy

   Immunocompetent patients

 

1 gram every 24 hours

no reduction

500 mg every 24 hours

500 mg every 24 hours

   Alternate dose for immunocompetent patients with less than or equal to 9 recurrences/year

500 mg every 24 hours

no reduction

500 mg every 48 hours

500 mg every 48 hours

   HIV‑1−infected patients

500 mg every 12 hours

no reduction

500 mg every 24 hours

500 mg every 24 hours

Herpes zoster

1 gram every 8 hours

1 gram every 12 hours

1 gram every 24 hours

500 mg every 24 hours

Hemodialysis

Patients requiring hemodialysis should receive the recommended dose of VALTREX after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of VALTREX is approximately 4 hours. About one-third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.

Peritoneal Dialysis

There is no information specific to administration of VALTREX in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with end-stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of VALTREX should not be required following CAPD or CAVHD.

Dosage Form & Strengths

Tablets:

  • 500-mg: Each blue, film‑coated, capsule‑shaped tablet printed with “VALTREX 500 mg” contains 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg of the free base.
  • 1-gram: Each blue, film‑coated, capsule‑shaped tablet, with a partial scorebar on both sides, printed with “VALTREX 1 gram” contains 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of the free base.

Tablets: 500 mg (unscored), 1 gram (partially scored) (3)

Caution should be exercised to prevent inadvertent overdose [see Use in Specific Populations (8.5, 8.6)]. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4)].

VALTREX tablets (blue, film‑coated, capsule‑shaped tablets printed with “VALTREX 500 mg”) containing 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg valacyclovir.

Bottle of 30 (NDC 0173-0933-08).

Bottle of 90 (NDC 0173-0933-10).

Unit dose pack of 100 (NDC 0173-0933-56).

VALTREX tablets (blue, film‑coated, capsule‑shaped tablets, with a partial scorebar on both sides, printed with “VALTREX 1 gram”) containing 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of valacyclovir.

Bottle of 30 (NDC 0173-0565-04).

Bottle of 90 (NDC 0173-0565-10).

Storage:

Store at 15° to 25°C (59° to 77°F). Dispense in a well-closed container as defined in the USP.

Sours: https://www.healthgrades.com/drugs/valtrex/dosage

Valtrex for Cold Sores: Is It Right for You?

Introduction

Cold sores are painful and oozing, and they always seem to appear before that wedding or class reunion. Also called fever blisters, the small, fluid-filled lesions typically form near or on your lips and can cause symptoms such as tingling, itching, or burning.

They’re caused by the herpes simplex virus. There are two types of herpes virus. Cold sores are typically caused by type 1 virus (HSV-1). But in some cases, HSV-1 can cause sores on the genitals and type 2 virus (HSV-2) can cause sores on the mouth.

There’s no cure for cold sores. But, because they’re caused by a virus, they can be treated with antiviral medications. These include the prescription medication Valtrex.

Valtrex, which contains the active ingredient valacyclovir, can help your cold sores clear up faster. It can also reduce the number of cold sores you get. Read on to learn how Valtrex works and how to use it to treat your cold sores.

Treating cold sores with Valtrex

Cold sores typically start to heal on their own within about four to six days. Although, the first cold sore you get will likely last longer.

Most people don’t require treatment for their cold sores, but, in some cases, a doctor may prescribe an antiviral medication such as Valtrex. This may be because you get cold sores often or if you’re at high risk of serious complications, such as from a weakened immune system.

To treat a cold sore, you take Valtrex on the day you notice a cold sore forming. Valtrex works by preventing the herpes virus from growing and spreading.

Your doctor may also prescribe Valtrex to help prevent future cold sores, which is an off-label use. In that case, you and your doctor would work together to create the best treatment plan for you.

Dosage

Valtrex is an oral caplet. It comes in 500-milligram and 1-gram strengths. It’s available as a brand-name product as well as a generic medication (valacyclovir). The generic product is an oral tablet which comes in the same strengths.

For adults and children 12 years and older

The recommended dosage is 2 grams twice daily, taken 12 hours apart, for one day. Valtrex should be started at the earliest signs of a cold sore.

For children 11 years and younger

Valtrex is not recommended for treating cold sores in children of this age group. But it can be used to treat chickenpox in children ages 2 years and older.

Effectiveness

In one , people who took Valtrex had shorter cold sore episodes by about one day compared to people who didn’t take Valtrex at all. Most people in the study took Valtrex within two hours of noticing their first cold sore symptoms.

Tips for taking Valtrex

  • Take Valtrex at the first sign of a cold sore.
  • You can take it with or without food.
  • Don’t take more than the prescribed number of caplets each day.
  • If your child can’t swallow caplets, ask your pharmacist to make the caplets into an oral suspension (liquid).
  • Be sure to drink lots of water. Since your kidneys help remove the metabolized drug from your body, it’s important to stay hydrated to lower the risk of serious side effects, such as kidney damage.

Side effects of Valtrex

The more common side effects of Valtrex include:

  • headache
  • dizziness
  • nausea
  • vomiting
  • stomach pain

The serious side effects of Valtrex can include:

Warnings

Valtrex may not be the best choice for certain people.

People with kidney damage or kidney failure may need a lower dosage of Valtrex. Be sure to tell your doctor if you have kidney problems before you start taking the drug.

If you’ve ever had an allergic or other serious reaction to Valtrex, Zovirax (acyclovir), or the ingredients in them, do not take Valtrex without talking to your doctor first.

Other Treatment Options

Valtrex is not the only medication used to treat cold sores. Other medications include:

  • Zovirax (acyclovir)
  • Denavir (penciclovir)

Zovirax is an oral medication and it also comes in cream form. Denavir is a topical cream.

There are also natural treatments that may help ease symptoms of a cold sore during an outbreak.

Talk with your doctor

For more information about Valtrex, talk with your doctor. Feel free to review this article with them and ask any questions you have, like:

  • Is it important that I take medication to prevent cold sores?
  • Are there drug-free ways to help avoid cold sores?
  • Are there over-the-counter drug options that I could consider?

Together, you and your doctor can decide if Valtrex or another medication or treatment is a good choice to treat your cold sores. For more information, read about the seven best cold sore remedies.

Sours: https://www.healthline.com/health/herpes-labialis/valtrex
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Valaciclovir for the suppression of recurrent genital herpes simplex virus infection: a large-scale dose range-finding study. International Valaciclovir HSV Study Group

A randomized, double-blind study of valaciclovir for suppression of recurrent genital herpes was conducted among 1479 immunocompetent patients. Patients were randomized to receive valaciclovir (250 mg, 500 mg, or 1 g once daily, or 250 mg twice daily), acyclovir (400 mg twice daily), or placebo, for 1 year. All valaciclovir dosages were significantly more effective than placebo at preventing or delaying recurrences (P < .0001). There was a dose-response relationship (P < .0001) across the once-daily valaciclovir regimens. Twice-daily valaciclovir and acyclovir were similar in effectiveness. Subgroup analysis showed that patients with a history of < 10 recurrences per year were effectively managed with 500 mg of valaciclovir once daily. One gram of valaciclovir once daily, 250 mg of valaciclovir twice daily, or 400 mg of acyclovir twice daily were more effective in patients with > or = 10 recurrences per year. Safety profiles of all treatments were comparable. Thus, valaciclovir is highly effective and well tolerated for suppression of recurrent genital herpes. Once-daily regimens offer a useful option for patients who require suppressive therapy for management of genital herpes.

Sours: https://pubmed.ncbi.nlm.nih.gov/9728526/

Herpes is not simply an infection. Too many people suffer silently, fearing to even reach out to their healthcare providers. There are few conditions where a person’s care is so dependent on their participation. Time must be dedicated to education and to formulating a plan that is under your control.

Medication is available—and it works extremely well—but how it is used and when it is used can never be more precisely applied than when a person uses the guidance of experts to craft a personalized plan.

With the education we provide below, you will be able to decide how best to utilize all the tools at your disposal. The key is to learn as much as you can and make informed decisions. The information below will help you gain a level of independence you may not have realized is possible.

Read carefully your healthcare professional’s personalized treatment plan and all the material provided. It may well provide some new information that will be helpful to you. Nothing is sugar coated because we feel you deserve the information you need to live your life the way you want. Read it all along with the package insert and the information in the Prescribers’ Digital Reference (PDR).

One important point is that if the medicine prescribed does not improve your condition (now or at any time), or if your symptoms at any point in the future are not completely typical of your usual outbreak, then you must be seen by a physician in person and checked for other conditions.

Lastly, the plan your personal doctor or nurse practitioner has provided is just the initial plan.

You may well choose a different one after reading more about other options or, in 6 months, your life circumstances may have changed and a different plan may suit you better. Just reach out to us.  

We are here to make your life better, not to give you more challenges in finding the care you need. And don’t forget, contact us if you need us.


Your doctor or nurse practitioner has reviewed your medical information and has prescribed valacyclovir 500 mg to treat genital herpes. Valacyclovir has been approved to treat genital herpes in several ways. It can be taken to lessen the severity of an initial outbreak, to abort outbreaks when someone feels telltale signs (the prodrome) that tells them an outbreak is about to happen, or to prevent outbreaks and reduce the risk of transmitting herpes by taking one pill every day.

Your doctor or nurse practitioner has written a prescription for valacyclovir to be used to limit outbreaks and reduce the risk of transmitting herpes by taking one pill every day. One of the most important advances in herpes treatment came with the knowledge that transmission from an infected person to their uninfected partner could be reduced by the use of daily valacyclovir.

Valacyclovir not only reduces the number of outbreaks a person experiences when using the medication every day but it reduces the number of days that someone sheds the virus asymptomatically (shedding of the herpes virus from normal skin when a person feels completely well).

Asymptomatic shedding is how most transmissions occur. Reducing asymptomatic shedding results in fewer uninfected partners catching herpes. If a condom is worn and the medication used, the chances are cut in half compared to using a condom alone. Fewer outbreaks and fewer episodes of asymptomatic shedding means fewer people become infected.

In one study that followed the course of 144 couples in which one partner was infected and the other not infected, transmission occurred in 14 couples. In 9 of those cases, the person who transmitted the disease was completely free of symptoms—no outbreak, not even a prodrome (a warning that an attack was coming). The other 5 transmissions happened when the person who was infected had a prodrome or developed lesions near the time the infection was transmitted. As noted, the key to preventing transmission isn’t just limiting outbreaks but reducing asymptomatic shedding. Valacyclovir, taken daily, reduces the number of outbreaks a person experiences and the number of days that someone sheds the virus asymptomatically.

To reduce the number of outbreaks an infected person experiences and to reduce the risk of transmission to an uninfected partner (by up to 50%), the PDR recommends the infected partner take valacyclovir 500 mg/day.

The study measured results “in monogamous, heterosexual relationships when combined with safer sex practices.” The data are strong but refer to patients with 9 or fewer outbreaks each year. Also, the study ran only for 8 months.


An important point
Herpes can be transmitted to a partner despite best efforts like using a condom and using antiviral suppression therapy. Patients should never engage in sex without a condom or when they have an outbreak or a prodrome. Also, as asymptomatic shedding is more common in the seven days following an outbreak, it is prudent to avoid sex during that period, as well.

The following information (Preventing future outbreaks and Other ways to use the medication) is relevant if at some point you decide to go off suppression therapy and choose to try to abort outbreaks and use suppression therapy in some specific situations only.

Preventing Future Outbreaks

If you are just trying to abort outbreaks, make a note of everything you think may have made you more susceptible to an outbreak. Was there more irritation to the area? Did anything affect your immunity like another infection (e.g., a cold) or did you change something in your lifestyle that could have weakened your immune system (e.g., lack of sleep, stress, increased alcohol consumption)? No change is too small to note.

This is important because it will help you maintain the patterns that make herpes less likely to appear. For you, it may be a lack of sleep over a few consecutive nights that spurs most outbreaks. It might be excessive sun exposure or too much alcohol consumption. It could happen only when you are sick or just run down. Whatever it might be, over time you may come to recognize the issues and make changes that reduce the frequency of outbreaks.

Other ways to use the medication

Some patients ask if they can take the medication to prevent an outbreak when they least want to have one. The classic examples are a bride or groom on their wedding day, when first engaging in sex with a new partner, or going on that long planned and much-needed vacation with your partner or spouse. You don’t need to be getting married or about to rendezvous for a much-anticipated tryst to want to prevent a herpes outbreak at particular times. It could be that an outbreak would be uncomfortable during the holidays or at any time you determine.

That is what we mean when we say you have control. At one point in life, a person may choose to abort outbreaks when they feel them coming on, at another point they might choose suppression therapy, but that may change, too. Circumstances change; only you will be able to know how your circumstances affect which option you choose. That is why learning all you can is so important. It gives you independence. Things change and how you choose to use valacyclovir may change.

One other fact is worth noting. You have been prescribed 30 pills of valacyclovir 500 mg every month. You should always have medication on hand, so renew your prescription well before you run out. As long as valacyclovir proves effective and you are free of significant side effects, you should never have to worry about having access to what you need.

You can always drop a note to your doctor or nurse practitioner, the pharmacist, or the care team with any questions, issues, or changes you want to consider. There is no “extra” visit charge or cost if you just want to ask questions and learn more about how you can manage your condition.

Lastly, if you would like to switch to intermittent therapy, you can always hold back on getting more valacyclovir delivered.

This may be a new situation for you but as long as the medication works without causing you difficulties of any sort, you are in control.    


A wealth of herpes information (oral and genital)

In the United States, genital herpes caused by HSV-2 (Herpes Simplex Virus Type 2) is extremely common and the most frequent cause of genital ulcer disease. Yet, the people who have symptoms represent the smallest number of people infected. In fact, 80% of the people who have genital herpes do not know it. That means for every person with symptoms who takes the step to be treated as you have, there are 4 people who are infected but totally unaware. 

Much of what we know about herpes is different from what people learned during the height of the “fear” an infection caused when no treatment was available.

That is what we must change. We want you to learn the facts about herpes so you do not become a victim of the myths. Also, only by understanding the disease will you be able to work with your doctor or nurse practitioner to craft the right treatment plan for you as your life evolves. What suits you today may not in 6 months or in 5 years. If you understand herpes, and how medications can work in different circumstances, you will be able to take control of your life in ways you might not have known were possible.

Lastly, if you read the next few pages carefully (though seemingly simply) you probably will know more helpful facts about herpes than many doctors.

What is herpes?

Herpes is a virus. The herpes virus can barely be considered alive. It is little more than a strand of DNA (deoxyribonucleic acid), the code of life, safely hidden inside a shell of protein. On its own, a herpes virus cannot reproduce or do much of anything—until it infects us. When the herpes virus comes in contact with areas that are receptive, like the genitals or mouth, the virus invades the epithelial cells (skin cells) in that region.

Then, the DNA of the herpes virus is released into the skin cell. At that point, it quite literally takes over.

It directs the cell to make more herpes virus and, when they have made enough copies to damage the cell so severely that it bursts, millions of the newly formed viruses are released infecting more cells, eventually causing an ulcer.

That is what people can see and feel, but a good deal more than that happens. While it is infecting skin cells and causing pain and ulcers, it also begins to attack the nerve cells in the same area. When the virus enters the nerve cell, it not only reproduces but it moves up the nerve to a bundle of nerves in the back called the sacral plexus. Once it is in the nerves, it is essentially protected from being attacked by the body’s immune system. Nerve cells can never be replaced.

That is why when nerves in the spine are damaged people become paralyzed. Since nerves cannot reproduce themselves easily, the body is careful not to bombard them with all the weapons it has to clear infections. All the inflammation that is caused by the battle to eliminate infections elsewhere would be disastrous if that occurred with nerves.

There is no sense clearing an infection if nerve cells that could never be replaced are destroyed in the process.

The herpes virus is essentially protected from an attack by our immune system as long as it hides out in the nerves of the sacral plexus when it affects the genitals, or the “dorsal root ganglion” (a cluster of nerves in the neck region of the spine) when it infects the mouth.

Unfortunately, that leaves the virus in a perfect position to sneak back out when the immune system is suppressed in any way. That is how the virus is able to cause recurrent infections, especially during times of stress, illness, or any condition or circumstance that makes our immune system less vigilant. We will discuss that in detail later.

How common are HSV-1 and HSV-2?

Worldwide (in 2012) nearly one half billion people were infected with HSV-2 between the ages of 15 and 49—and the number rises with age and the number of life partners. More women than men have herpes (14.8% versus 8% global prevalence, respectively). In the US, the number of people infected has been dropping, but the news isn’t all good. The percentage of people with a positive blood test for HSV-2 has declined. In people age 14 to 49, 21% were positive in the early 90s. By 2010, that number dropped to about 16%. Unfortunately, the improvement has been seen mostly in the white population “with stable rates in black populations, resulting in worsening racial disparities such that for every one white man, four black men are infected, with similar ratios for women.”

The reasons for this might be that access to information, education—and the medication that can reduce the risk of transmission—has not been made available to all equally.

In the United States, the prevalence of HSV-1, which accounts for the vast majority of oral herpes, has dropped 29% among 14–19 year olds, from approximately 42% to 30%, over the past 30 years. As a result, adolescents and young adults may experience their first exposure to HSV-1 with the initiation of sexual activity, including oral sex.

How can it be that some people do not have symptoms of oral herpes and of genital herpes?

It is vital to understand that 80% of people with an infection have no symptoms they recognize. For those who experience severe or frequent outbreaks, that is difficult to understand. There are multiple explanations.

The first one is related to how we physicians first described the disease.

Before there were elegant tests to culture herpes, or to test lesions for signs of herpes DNA, and before accurate blood tests out of the University of Seattle, herpes was described by doctors by what they saw—and only by what they saw. This meant that only people who had visible lesions (sores) were diagnosed and doctors thought that all those who had herpes had symptoms. It turns out that patients with severe disease were just the tip of the iceberg, but doctors didn’t realize that. Unfortunately, too many myths and outright falsehoods became “common knowledge.”

The fact is most people have an immune response that holds the disease at bay—in terms of causing symptoms, that is. They are still infected and, as we will learn later, still able to transmit the disease, but the symptoms either do not occur or are so subtle that they go unnoticed or undiagnosed. Herpes can cause such minor complaints that they are ignored.

Herpes can appear as little more than an irritation or tiny erosion. A lesion tucked away in the genital region can be so small that it cannot be seen without doing some major stretching before trying or using a magnifying lens. Or the sore is in a place that is completely inaccessible to viewing (e.g., the anus, the groin, the vagina, or hidden within a small skin fold).

Also, the symptoms may disappear so quickly that they are dismissed, or never seen in time by a doctor, or a doctor does not recognize how minor herpes can be even when seen in time. This is true of oral and genital herpes.

Nevertheless, the people who have what we call asymptomatic herpes can still transmit the disease. They can do this because they can still “shed” the virus from the skin even without having a sore or a symptom that they recognize as herpes. Asymptomatic shedding occurs from the mouth in those with oral herpes, from the anal and genital region in those with genital herpes, and even from tears in people who have had herpes of the eye. The section on asymptomatic shedding explains this in detail.


Clinical manifestations of Oral HSV infection

Classically, the oral symptoms are familiar to most people who either have had an outbreak or seen them in others. The initial symptoms are a sense of tingling or itching that can occur 24 hours before any lesions appear.

The first visible symptoms are redness, followed by the forming of a papule or elevation of the skin affected (usually on the very edge of the lips where they transition to the skin of the face). Then, the small roundish elevations become filled with fluid (a vesicle), which can burst and reveal a small ulcer or divet in the skin. This will be painful and ooze fluid and within just a few days heal, usually without a scar. These lesions do not form solely on the edge of the lip. They can form anywhere on the face, particularly a region between the nose and lips and out to the first fold on the cheek called the “nasolabial fold.”

The virus hides in the nerves in the back of the neck called the dorsal root ganglion. When HSV-1 reactivates and comes out of that nerve it can take a route other than to the edge of the lip. It can even cause an outbreak on the back of the neck but, most often, it is the lips where outbreaks will recur.

Oral symptoms can be more easily seen but often are not understood to be related to herpes. Minor irritations that disappear quickly might easily be dismissed as a simple cut or reaction to spicy food.

Other people might mistakenly consider unrelated irritations to be herpes on the mouth when they are not. For example, canker sores that occur inside the mouth and can recur just like herpes are sometimes misdiagnosed by patients and doctors alike as being due to the HSV-1 virus when, in reality, it is possibly an immune reaction and not an infection. The same sometimes occurs with irritation on the corners of the mouth, called angular cheilitis or perleche. This can be idiopathic, meaning it has no known cause, or can be due to the buildup of fluid at the corners of the mouth. It is a perfect spot to nurture growths of yeast or fungus (think Candida) and the irritation can even lead to small cuts and sores.

We always advise patients to confirm their diagnosis if recurrent oral lesions are completely unresponsive to herpes antiviral therapy.  

Clinical manifestations of Genital HSV infection

HSV-2 is the leading cause of genital ulcers in the United States and throughout the world. We know that because a very accurate test called a PCR test, which is far more sensitive than a culture, has found herpes in 60% of genital ulcers. Remember that most people with herpes found by blood testing have had no symptoms of herpes. What follows is a description of herpes as it appears in those who experience symptoms, in people who are seen by doctors with lesions.

First outbreak or primary outbreak

For patients who have symptoms, the first outbreak can be the worst. During primary infection, patients may experience multiple genital ulcers that can cover larger areas of skin. It can be on both sides of the groin and be quite painful. They often experience burning during urination in addition to the local pain. They can have fever, headaches, muscle and joint pain, and their lymph nodes in the groin can be swollen and painful as well. With no therapy, the lesions will clear and heal without scarring (typically) in about 21 days. Therapy can shorten that period significantly.

The reason an initial outbreak can be so severe is that there are no antibodies to herpes when the virus first enters the body, (though a prior history of herpes type 1 can give someone antibodies that work a little bit to fight herpes type 2 and may make an outbreak a bit less severe.)
An initial outbreak can be caused by Herpes 1 and in developed countries like the US, the most common cause of an initial attack of herpes is actually herpes 1. Most people do not realize that someone infected with oral herpes from type 1 can perform fellatio or cunnilingus on a partner and transmit herpes 1 from their mouth to their partner’s genitals. If you think about it, why not? The problem is that many people don’t know they have oral herpes. It may be easier to see but not many people remember the cold sore they had when they were 3. Also, while most people in the past acquired herpes on the mouth as a child when exchanging saliva with other children who were infected, that has not been happening with anywhere near the same frequency. The rate of infection with Herpes 1 is lower now than at any time in the past. In the United States, HSV-1 has dropped 29% among 14–19 year olds, from 42.6% to 30.1% over the last 3 decades.

That means that adolescents who engage in sex are more likely to be exposed to Herpes 1 for the first time when having oral or vaginal sex. Changes in sexual practices have also made the transmission more likely.

Fellatio (a “blow job”) and cunnilingus (“going down”) are much more frequently practiced at younger ages and with fewer restraints imposed by cultural or social forces. That has made herpes 1 the most common cause of first outbreaks in developed countries. Nevertheless, herpes 1 and herpes 2 on the genitals do not behave identically in terms of recurrences. Herpes 1 is more “at home” in the oral region and has developed ways to deal with that environment. When on the genitals, it can cause all the same symptoms and can still be transmitted, but it has a milder course than when herpes 2 infects the genitals. This is discussed more in the section on recurrences.

Understanding how herpes can remain in the body yet be kept at bay to some degree is pivotal. Herpes enters the sacral plexus of nerves during an initial infection. As discussed above, the virus remains safe from attack by antibodies and the immune system as long as it is tucked away in the nervous system. That little trick, entering the nervous system where it neither damages the nerves nor can be attacked, makes herpes a particularly stubborn infection. It can slide down the nerves that go from the sacral plexus to the skin and cause more outbreaks in the future. These are called recurrences.

Recurrences occur in a milder version than the initial outbreak because the body is not completely defenseless. It is the ongoing battle between the herpes virus’ ability to stay safe in the nervous system and the body’s ability to mount a defense with antibodies that determines if symptoms will appear or not. In most people, the battle is a stalemate in terms of symptoms. Most people never have an outbreak or, if they do, they are so mild they are not noticed. In terms of keeping herpes under such control that the virus never exits the nervous system and sheds from the skin, the battle definitely tilts in favor of the virus.

It is in the ways herpes remains active in those who are infected, and able to spread to those who are not, that makes herpes such a difficult infection to control in terms of preventing outbreaks and preventing transmission.

However, control is possible—and that is the key.

Recurrences

While the immune system for the vast majority of people makes recurrences far less severe than a primary outbreak, periodic recurrences occur in genital HSV infections. They are also quite different in character.

First, since herpes is in the nerves of the patient, as the virus becomes more active and begins to travel down the nerve to the skin, a person may get symptoms that tell them an outbreak on the skin is about to appear.

They may get leg pain, back pain, a tingling sensation, burning, or itching. They might notice less specific symptoms like increased urination, but symptoms like fever or muscle aches are much less common than with an initial outbreak. These symptoms collectively are known as a prodrome. It is very variable but patients begin to recognize their pattern, their unique prodrome.

The outbreaks themselves are much milder. They tend to occur on one side of the body, to cover a smaller area, and are less painful. Swelling of the lymph nodes is uncommon and all the symptoms resolve much more quickly, lasting just 3–5 days.

Because herpes lives in the sacral plexus and nerves from that accumulation of nerves can reach out not just to the skin where the infection first started but to any area the nerves can go, recurrent outbreaks are not limited to the initial region it entered the body. They can occur on the buttocks, the thigh, or anywhere in the anal and genital regions. Recurrences in areas other than the genitals (e.g., thigh) have a similar pattern to those that occur on the genitals.

Also, while herpes tends to improve over time, people can get outbreaks at any point that their immune system is challenged. This can happen when another illness occurs, with cancer or cancer treatments, or with such simple changes as life stress due to divorce, moving, changing jobs, or death of a family member as examples. Excessive friction, sunburns, exhaustion, poor sleep patterns can also deplete a person’s immune system. In fact, anything that makes you less healthy or is a challenge to the system can make an outbreak more likely to occur. Over time patients not only recognize their prodromes, but they also recognize the circumstances associated with an outbreak.

In terms of the frequency of recurrences, genital HSV-2 recurs far more often than genital HSV-1. In the first year after primary infection with genital HSV-2, patients average about 5 recurrences. That drops by approximately 2 outbreaks per year in the following year. In the first year after a genital HSV-1 infection, the recurrence rate is just 1.3 outbreaks/year. That drops to a mere .7 outbreaks/year in the second year.

Those statistics can be misleading, however. Some patients have no outbreaks and others can experience 9 or more outbreaks per year. It is incredibly variable.

Remember, these statistics are all about symptoms. People often wonder why someone who had symptoms or who knew they had herpes, and who had outbreaks, would have sex when they had an outbreak and could transmit the disease. The problem is that herpes is shed from the skin even when people who get outbreaks feel perfectly well. Also, even the people who have no history of herpes, but in whom we know herpes is present (by blood tests), shedding of the virus from the skin occurs silently and the potential to transmit the virus exists.

This is called asymptomatic shedding and occurs in anyone who has herpes—whether they have symptoms or not.

What is asymptomatic shedding?

When a genital herpes outbreak occurs, the virus can be cultured for about 11 days with an initial outbreak and for about 4 days with a recurrence. Yet, the question is whether the virus can be found on the skin even in between outbreaks.

As it turns out, the herpes virus becomes active and can be “shed” from the skin on days when patients who have recurrences of genital HSV-2 feel perfectly well and in people who have only a positive blood test for HSV-2 and have never had an outbreak. In a pivotal study, women with symptomatic genital herpes Type 2 collected cultures from the cervix, vulva, and the rectum every day for over 3 months. They kept track of their symptoms with a daily diary, as well.

Shedding occurred without symptoms on 2% of the days in women with HSV-2 genital herpes. They shed more frequently in the 7 days prior to or following an outbreak. Shedding lasted fewer days when they were free of an outbreak but still accounted for one-third of all the days they shed the virus.

But what is the case for the over 80% of HSV-2-seropositive persons in the United States who are not aware that they are infected with HSV-2? Using a very advanced test called PCR (Polymerase Chain Reaction), samples from patients who had herpes type 2 but who had never had symptoms were compared to patients with genital HSV-2 who had symptoms in terms of shedding the herpes virus. The patients who had a history of symptoms shed the virus when they had no symptoms on 13% of days while those who only had HSV-2 by blood testing shed on 9% of days.

What is interesting is that the amount of virus shed during when no symptoms were present was essentially the same in both groups.

The precise rate of genital HSV-1 shedding in between outbreaks is not known but it is suspected it is far less than genital HSV-2 herpes. One small study using cultures, and not the much more sensitive PCR test, found shedding on only 1 out of every 200 days. Unfortunately, we know that HSV-1 also sheds asymptomatically from the mouth and in developed countries like the US, it is responsible for most of the new infections of genital herpes.

Some things are associated with a risk for shedding and some things are not. With genital herpes, time of the month in relation to menstruation, sexual orientation, and sex were not. Having a history of prior outbreaks, especially a history of more than 8 outbreaks/year, and being Caucasian, are a risk for an increase in asymptomatic genital shedding, as well as an increase in overall shedding (symptomatic and asymptomatic shedding combined).

Duration of asymptomatic shedding

Another factor associated with asymptomatic shedding is how long a patient has had the infection. The first year after acquiring genital HSV is the most difficult symptomatically—and it makes sense that would be the year with the most shedding of the virus. In one study, the shedding rate declined from one-quarter of days in the first year to 13% in the years that followed; however, the rate never seems to drop to 0. Even in people with HSV-2 who had the disease for 20 years, shedding still occurred on more than 10% of days.  

Herpes transmission

It has become clear that people who have antibodies in their blood to Herpes Type 2 shed the virus from their skin whether they have a history of outbreaks or not. Basically, if someone has antibodies to herpes, they are capable of transmitting the disease. In one study that followed the course of 144 couples in which one partner was infected and the other not infected, transmission occurred in 14 couples. In 9 of those cases, the person who transmitted the disease was completely free of symptoms—no outbreak, not even a prodrome (a warning that an attack was coming).

The other 5 transmissions happened when the person who was infected had a prodrome or developed lesions near the time the infection was transmitted. This makes sense. Shedding of the virus frequently occurs within 7 days of an outbreak, either before or after.

In another study of a vaccine that was totally ineffective 155 people acquired herpes from their partner. Only 57 people who became infected had any symptoms of herpes. That means 99 people acquired the infection and only knew about it because they were in a study and had a very accurate blood test that confirmed the infection. This is consistent with what we know, which is that the disease is most often transmitted by asymptomatic shedding (when people have no symptoms) and that the people who become infected most will have no symptoms (yet will be capable of transmitting the disease).

Some Important Information about Safe Sex

Although genital herpes is not generally a dangerous disease, most people want to do what they can to decrease the risks of transmitting the virus to their partner(s). There are a few methods that can help.

Using condoms: Condoms decrease the risks of transmitting STDs and double as contraception.

Taking suppressive therapy: Using valacyclovir daily to manage genital herpes decreases both outbreaks and asymptomatic shedding.

Asymptomatic shedding is the cause of most transmissions of herpes.

Abstaining from sex around outbreaks: Shedding is more common 7 days before and 7 days after outbreaks. Abstaining from sex for 7 days after an outbreak can decrease the risk of transmitting the herpes virus. Of course, it’s also important to abstain during your prodrome and an outbreak.

Lastly, you and your partners should always inform each other about STDs. Honesty is an important part of any sexual relationship. With treatment and a few precautions, genital herpes is highly manageable and the risk of transmitting it to a partner can be reduced significantly.

Herpes and pregnancy

In terms of transmission, women with herpes are often concerned most about transmitting the infection to their child during childbirth. They wonder how they can protect their baby if they could be shedding the virus and not have any symptoms. They wonder if they should take medication to reduce shedding the herpes virus; they fear they might need a C-section or even ask for one “just to be safe.” It is true that subclinical genital HSV shedding at the time of labor and delivery can infect a neonate and cause neonatal herpes, or herpes of the newborn—but it is exceedingly rare.

In one study, only 202 women out of more than 40,000 women who had genital HSV cultures at delivery were shedding herpes. Only a quarter of them had lesions; the rest were shedding subclinically. Out of those 40,000 women, only 10 newborns became infected but they all acquired herpes from mothers who were shedding asymptomatically.

The worst cases of newborn herpes happen when a mother becomes infected at the end of pregnancy and has not yet developed antibodies to herpes, antibodies she can share with a baby while in the womb, antibodies that go a long way toward protecting the newborn as it travels the birth canal.  

Herpes on other parts of the body

Herpes Whitlow

Herpes can infect skin on other areas of the body other than the mouth and genitals. You have learned how once the virus enters the body through the genitals and finds a home in the sacral plexus, it can travel back down any nerve in that cluster of nerves and reach the skin on the buttock, thigh, anus, rectum, or anywhere in the region of the groin.

However, the virus can enter the body any place that it lands where the skin might be more receptive because of a cut or tiny opening. This has been seen on the fingers and when herpes occurs on the finger, it is called a whitlow. This was most often seen in the past in dentist and dental healthcare providers.   

Herpes of the eye

Herpes can infect the eye and is called Herpes Simplex Keratitis. It most often involves only one eye and affects the cornea. It can cause pain, redness of the eye, tearing, light sensitivity, and a feeling like there is grit in the eye. Unlike herpes elsewhere, topical antiviral therapy is the treatment that is most effective when an outbreak occurs. It is noteworthy that viral shedding occurs in tears even when patients have no symptoms and that treatment with valacyclovir decreases the number of recurrences just like it does for infections elsewhere.

Treatment

Treatments for herpes (oral and genital) have been available for decades. The first highly effective medication was acyclovir. It proved effective in shortening outbreaks and was a boon at a time when so little seemed to work. In those early days having anything that could shorten an outbreak and even prevent them changed how people saw the disease.
Acyclovir worked in a very targeted way against Herpes DNA. In reality, there isn’t much more to a virus than its DNA and the proteins that cover it. To affect the virus, it is nearly essential to attack its DNA and that is what acyclovir does. DNA is made up of four repeating chemicals called nucleosides. How they are put together in a sequence determines everything, and we mean everything. It is the code of life. So, anything that stops a virus from making more of its DNA stops the virus from making more of itself. Acyclovir is almost an identical copy of one of those nucleosides (Guanine) that makes the code of life—almost an identical copy. One small change to the part of DNA that makes a chain grow makes it so acyclovir can be placed in the growing line of code while lacking the small structure needed so the next piece of code can be added. The chain terminates. Acyclovir is known as a synthetic nucleoside analog.

One limitation was that acyclovir was limited in how much could be absorbed through the intestines. Only 20% of it was ever used by the body. This limitation was overcome by creating something called a prodrug of acyclovir. Since Acyclovir is so poorly absorbed through the gut a mechanism was sought that would allow acyclovir to cross the bowel and get into the bloodstream.

By adding the amino acid l-valine to acyclovir, valacyclovir is created. With that extra amino acid, valacyclovir can be absorbed much better than acyclovir. Once in the body, the amino acid, valine, is severed from the valacyclovir and acyclovir can do what it does but now much more effectively since so much more of it is in the bloodstream. Twice a day or even once a day valacyclovir works better than 3–5 times/day of acyclovir. Another drug, famciclovir, uses the same concept to help penciclovir enter the body.


There are any number of conditions where doctors will assure patients that no one knows their disease as the patient does. That is never truer than with herpes. Recurrences can be so subtle that patients can detect them even when clinicians may glance over them without noticing a thing. Most importantly, however, many patients learn to recognize the unique prodrome that warns them an outbreak may be coming. Patients can identify specific shifts in senses and feelings that seem trivial but are consistent signals that the virus is about to make itself known. It can be a dull ache in the back of the thigh, a small increase in the frequency of urination, an odd discomfort in the groin, a sensitivity of a particular patch of skin; it can be anything, but it is specific. While patients may not have prodromes or outbreaks, those living with herpes recurrences often can predict an outbreak with uncanny accuracy.

What follows is a general discussion of the different ways medication can be used with more specific dosing guidelines following the discussion.

Genital herpes

To treat or abort an outbreak when there are early symptoms (prodrome)

That kind of knowledge can allow some patients to use the medication to abort an outbreak. Whether oral or genital, people can take medication when their specific prodrome tells them an outbreak is on the horizon. The medication will stop an outbreak cold (often) and when it does not, it can shorten a milder outbreak than they might have had otherwise.

To prevent outbreaks when there are no symptoms but outbreaks are more likely

Patients also learn the life circumstances or behaviors that lead to more outbreaks. For some, a lack of sleep, increased alcohol, another illness, stress, too much sunlight, irritation, or anything, in fact, that can affect one’s immunity can spur an outbreak. That means that some patients can know not just when they feel an outbreak coming on but can know when they are more likely to have an outbreak due to their circumstances. They might be under stress, having more sex so more irritated, drinking a bit more than they should or missing sleep over an extended period. They will know that they should avoid those triggers and do their best to do so, but they also might want to take medication preventatively knowing they are more vulnerable at that time. Essentially they might take the medication for a week or two until the stress that is making them more susceptible to an outbreak has resolved.

To suppress outbreaks for an extended period

Another way patients can take the medication is when they know they absolutely would like to do all they can to reduce their chance of having an outbreak at a pivotal time. The classic example would be during a honeymoon but taking medication to suppress outbreaks on a daily basis can be prudent when going on vacation, starting a new job, in a new relationship, or at any time a patient feels it is how they want to approach their condition. And that’s the key.

How medication is used is completely in your hands. Learn everything you can and do not worry about using the medication in the way that suits you best. That may change as your circumstances change, or as the condition changes, or even as your mind changes.

To prevent transmission to an uninfected partner

One of the most important advances in herpes treatment came with the knowledge that transmission from an infected person to their uninfected partner could be reduced by the use of valacyclovir. Valacyclovir not only reduces the number of outbreaks a person experiences when using the medication every day but it reduces the number of days that someone sheds the virus asymptomatically. That results in fewer uninfected partners catching herpes. If a condom is worn and the medication used, the chances are reduced at least in half compared to using a condom alone.

Fewer outbreaks and fewer episodes of shedding means fewer people become infected.

Oral herpes

Abort an outbreak at the earliest sign or symptom (prodrome)

At that earliest sign, two tablets of valacyclovir 1000 mg for a total of 2000 mg is taken by mouth as the first dose. Then, 12 hours later, 2 tablets of 1000 mg of valacyclovir, for a total of 2000 mg, is taken as the second and final dose. The second dose can be taken sooner than 12 hours but never before 6 hours have passed. Adequate hydration makes sure the medicine is cleared through the kidneys as it should be.
The medication is only approved for two doses and there is no evidence in studies to advise the use of medication once lesions have appeared.


Treatment of initial genital outbreak

In patients with a first outbreak, the symptoms can be very severe. Multiple painful, genital ulcers can cover large areas of skin on both sides of the groin. They can experience burning during urination, fever, headaches, muscle and joint pain, and swollen, painful lymph nodes in the groin. With no therapy, the lesions will clear and heal without scarring (typically) in about 21 days. For such patients, treatment is vital and can shorten the outbreak and ease the symptoms significantly. For the treatment of an initial episode of herpes genitalis, the FDA recommends taking valacyclovir 1 gram (1000 mg) twice a day for 10 days starting at the first sign or symptom of lesions, preferably within 48 hours of onset. The “CDC recommends this same dose for 7 to 10 days; treatment may be extended if healing is not complete after 10 days.” For HIV-infected patients, they recommend 1 gram (1000 mg) every 12 hours for 5 to 14 days.

Treatment of herpes labialis (i.e., cold sores)

To abort an outbreak of herpes on the lips or mouth the recommendation is that the patient should take 2 grams (2000 mg) of valacyclovir at the first sign or symptom of lesions and a second dose 12 hours later. The second dose should not be taken within 6 hours of the first. Those are the only doses recommended but patients sometimes take another dose or two of just 1 gram if they continue to have symptoms, or if a mild outbreak follows.

The PDR states that for HIV-infected patients, 1 gram (1000 mg) be taken every 12 hours for 5 to 10 days. Despite what some patients do when having continued symptoms the PDR states, “there are no data supporting the effectiveness of beginning treatment after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer).”

Treatment of recurrent herpes genitalis, including HIV-infected patients

To treat a recurrent outbreak, the FDA recommends using 500 mg of valacyclovir twice daily for 3 days starting at the first sign or symptom of lesions—preferably within 24 hours of onset. The CDC recommendation is identical but adds in the choice of using valacyclovir 1 g (1000 mg) one time a day for 5 days. Valacyclovir 1 g taken every 12 hours for 5 to 14 days is recommended by the HIV guidelines. The PDR also states, “There are no data supporting the effectiveness of beginning treatment more than 24 hours after the onset of symptoms.”

Treatment with suppressive therapy

The PDR states that for suppressive therapy of recurrent herpes genitalis in all patients valacyclovir 1 gram (1000 mg) should be taken once daily.

However, “in patients with a history of fewer than 9 recurrences per year, 500 mg once daily may be given.” They note that “500 mg once daily regimen appears to be less effective than other regimens in patients with 10 or more episodes per year.”

The PDR continues, “Safety and efficacy of valacyclovir beyond 1 year have not been established. In HIV-infected patients, 500 mg by mouth twice daily. The safety and efficacy of therapy beyond 6 months have not been established.”

To prevent transmission to a partner

The PDR recommends the infected partner take valacyclovir 500 mg once a day to decrease the risk of transmission to the uninfected partner “in monogamous, heterosexual relationships when combined with safer sex practices.” The data are strong but refer to patients with 9 or fewer outbreaks each year. Studies also did not run for an extended period so the PDR also states, “The efficacy of reducing transmission beyond 8 months in discordant couples has not been established.” This means they can only vouch for the data for an 8 month period of time.

An important point

Being diagnosed with genital herpes means you have acquired a sexually transmitted infection. If you have been diagnosed with genital herpes, you should have been checked for other sexually transmitted infections when you were diagnosed, including but not limited to HIV and syphilis. If you have not been, you should be and this is highly recommended.

Herpes can be transmitted to a partner despite best efforts like using a condom and using antiviral suppression therapy. Patients should never engage in sex without a condom or when they have an outbreak or a prodrome. Also, as asymptomatic shedding is more common in the seven days following an outbreak it is prudent to avoid sex during that period, as well.

Herpes and the risk of HIV infection

HSV-2 infection puts a person at greater risk of acquiring HIV infection—as much as 2 to 3 times the risk of those without herpes. The reason is that herpes creates ulcers that can make it easier for HIV to enter the body but general inflammation of the genitals is also responsible for the increased vulnerability to the infection. In women and men with positive blood tests for herpes, specialized testing shows signs of inflammation on the cervixes of women and under the foreskin of men. The specialized test is the finding of CD4 T cells. This is probably the result of the body’s immune system constantly fighting the herpes virus and it is seen even when no outbreak is evident. Of note, some CD4 T cells have been shown in the lab to be more susceptible to HIV infection than skin samples tested under the same conditions. Moreover, CD4 T cells hang around in inflamed tissue long after outbreaks heal.

This is another reason why STD testing is always the rule when beginning a new sexual relationship and why, whether having an outbreak or not, a condom is essential.

HSV-2 infection in HIV-infected individuals

HIV infected persons who have genital ulcers due to herpes are more likely to transmit HIV, as HIV is shed from these ulcers. Herpes itself may behave identically in the HIV positive individual but they are more likely to develop acyclovir resistance and to have outbreaks that last longer and appear different from typical cases.

HIV positivity is a complex condition that requires careful evaluation by experts in the field.

HSV vaccines

After years of frustration, there are reasons to be optimistic that a vaccine to prevent, or even to treat, herpes may be achievable. The development of a vaccine has been spurred by the realization that controlling herpes would be a major step in controlling the spread of herpes around the world, especially in places where medication is unavailable.

Herpevac vaccine did not prevent the acquisition of genital herpes Type 2 but it did show moderate success against catching herpes Type 1 and in making the disease milder if someone caught it. The study included 8000 participants but they were all women so the data may not be consistent in men. Nevertheless, the fact that a vaccine worked for HSV-1 is encouraging, especially since so many new cases of genital herpes are due to HSV-1. A number of vaccines are being tested to see if they could reduce the number of outbreaks and, most importantly, the amount of asymptomatic shedding. One vaccine in early testing, GEN-003, reduced shedding by 55%.

The advances are being made that give hope to anyone who has the infection or is the partner of someone with the HSV virus.


Read full prescribing information Here

How can Valtrex be used

Treatment of herpes labialis (i.e., cold sores)

To abort an outbreak of herpes on the lips or mouth the recommendation is that the patient should take 2 grams of Valacyclovir at the first sign or symptom of lesions and a second dose 12 hours later. The second dose should not be taken within 6 hours of the first. Those are the only doses recommended but patients sometimes take another dose or two of just 1 gram if they continue to have symptoms, or if a mild outbreak follows.

The PDR states that for HIV-infected patients, 1 gram (1000 mg) be taken every 12 hours for 5 to 10 days. Despite what some patients do when having continued symptoms the PDR states, “there are no data supporting the effectiveness of beginning treatment after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer).”

Treatment of Initial genital outbreak

In patients with a first outbreak, the symptoms can be very severe.

Multiple painful, genital ulcers can cover large areas of skin on both sides of the groin. They can experience burning during urination, fever, headaches, muscle and joint pain, and swollen, painful lymph nodes in the groin. With no therapy, the lesions will clear and heal without scarring (typically) in about 21 days. For such patients, treatment is vital and can shorten the outbreak and ease the symptoms significantly.

For the treatment of an initial episode of herpes genitalis, the FDA recommends taking valacyclovir 1 gram (1000 mg) twice a day for 10 days starting at the first sign or symptom of lesions, preferably within 48 hours of onset. The “CDC recommends this same dose for 7 to 10 days; treatment may be extended if healing is not complete after 10 days.”

For HIV-infected patients, they recommend 1 gram (1000 mg) every 12 hours for 5 to 14 days. The PDR also notes, “The efficacy of treatment with VALTREX, when initiated more than 72 hours after the onset of signs and symptoms, has not been established.”

Treatment of Recurrent Herpes Genitalis, Including HIV-infected Patients

To treat a recurrent outbreak, the FDA recommends using 500 mg of Valacyclovir twice daily for 3 days starting at the first sign or symptom of lesions—preferably within 24 hours of onset. The CDC recommendation is identical but adds in the choice of using Valacyclovir 1 gram (1000 mg) one time a day for 5 days. Valacyclovir 1 gram taken every 12 hours for 5 to 14 days is recommended by the HIV guidelines. The PDR also states, “There are no data supporting the effectiveness of beginning treatment more than 24 hours after the onset of symptoms.”

Treatment with Suppressive Therapy

The PDR states that for suppressive therapy of recurrent herpes genitalis in all patients Valacyclovir 1 gram (1000 mg) should be taken once daily.

However, “in patients with a history of fewer than 9 recurrences per year, 500 mg once daily may be given.” They note that “500 mg once daily regimen appears to be less effective than other regimens in patients with 10 or more episodes per year.”

The PDR continues, “Safety and efficacy of valacyclovir beyond 1 year have not been established. In HIV-infected patients, 500 mg PO twice daily. The safety and efficacy of therapy beyond 6 months have not been established.”

To Prevent Transmission to a Partner

The PDR recommends the infected partner take Valacyclovir 500 mg once a day to decrease the risk of transmission to the uninfected partner “in monogamous, heterosexual relationships when combined with safer sex practices.” The data are strong but refer to patients with 9 or fewer outbreaks each year. Studies also did not run for an extended period so the PDR also states, “The efficacy of reducing transmission beyond 8 months in discordant couples has not been established.” This means they can only vouch for the data for an 8 month period of time. The PDR also states, “The efficacy of VALTREX for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy.” Centers for Disease Control 26 and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines

Maximum Dose

In children 12 years and older, adolescents, adults, and the elderly, the maximum daily dose is 4 grams if given for just 1 day and 3 grams/day if given for more than 1 day.

In children 2 years to 11 years, 3 grams/day is the maximum dose.
Safety has not been established in neonates, infants, and children less than 2 years.

Dose adjustments should be made for those with kidney impairment or issues. Decreased doses are needed as kidney impairment slows the clearing from the body of valacyclovir. The degree of impairment determines the decrease in the dosage. The elderly may have decreased kidney function and adjustments should be considered in such cases.

No adjustment is needed, generally, in patients with liver impairment.

However, if you have a liver condition or impairment, inform your doctor.

Overdose: Valtrex is not usually harmful unless you take too much for several days. An excess of Valtrex can cause vomiting, kidney problems, confusion, agitation, feeling less aware, seeing things that aren’t there, or loss of consciousness. For severe symptoms, go direction to an emergency room. Otherwise, talk to your doctor or pharmacist if you take too much Valtrex. Take the medicine pack with you.


Sensitivity or Allergies: Patients with sensitivity or an allergy to any of the following medications should not use Valacyclovir: Acyclovir, Famciclovir, ganciclovir, penciclovir, valacyclovir, or valganciclovir.

Kidney Issues: Dose adjustments should be made for those with kidney impairment or issues. Decreased doses are needed as kidney impairment slows the clearing from the body of valacyclovir. The degree of impairment determines the decrease in the dosage. The PDR states, “Acute renal failure and CNS (Nervous System) toxicity have been reported in patients with underlying renal (Kidney) dysfunction who have received inappropriately high doses of valacyclovir for their level of renal (Kidney) function. Patients receiving potentially nephrotoxic(Toxic to the Kidney) drugs together with valacyclovir may have an increased risk of renal dysfunction (impairment).”

The Elderly: The elderly are more likely to have impaired kidneys so they might not clear valacyclovir from their system as efficiently as they should. This can lead to inappropriately high levels of valacyclovir, which means the elderly may need lower doses of valacyclovir. The elderly are also more likely to experience neurological side effects, including: agitation, hallucinations, confusion, delirium, and other abnormalities of brain function termed encephalopathy.

Dehydration: When patients are dehydrated acyclovir can reform as a solid in the kidney leading to kidney damage. Patients should all remain well hydrated when taking valacyclovir.

Newborns, Infants, and children: Safety has not been established in neonates, infants, and children less than 2 years.

Pregnancy: While a registry that collected data on the 756 pregnancies of women exposed to acyclovir in the first trimester showed no greater occurrence of birth defects than occurs in the general population, the study size was too small to guarantee safety during pregnancy.

You should not take valacyclovir if you are pregnant or trying to become pregnant, unless recommended by your obstetrician/gynecologist or other healthcare provider.

Breastfeeding: The PDR states, “According to the manufacturer, valacyclovir should be administered to a nursing mother with caution and only when indicated. Although the American Academy of Pediatrics (AAP) has not specifically evaluated valacyclovir, systemic maternal acyclovir is considered to be usually compatible with breastfeeding…Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.”

Driving or Using Machines: Valtrex can cause side effects that affect your ability to drive. Don’t drive or use machines unless you are sure you’re not affected.

Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS): TTP/HUS is a rare condition but has occurred in patients with advanced HIV disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of VALTREX at doses of 8 grams per day. If any of these conditions apply to you, please inform your doctor and pharmacist.


What follows is a summary and does not include every side effect possible. Please, read the package insert and report any side effects you experience whether on the list below or not.

Very Common (may affect more than 1 in 10 people): headache

Common (may affect up to 1 in 10 people): feeling sick, dizziness, vomiting, diarrhea, skin reaction after exposure to sunlight (photosensitivity), rash, itching (pruritus)

Uncommon (may affect up to 1 in 100 people), feeling confused, seeing or hearing things that aren’t there (hallucinations), feeling very drowsy, tremors, feeling agitated

These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valtrex a day. They usually get better when Valtrex is stopped or the dose reduced.

Other Uncommon Side Effects: shortness of breath (dyspnea), stomach discomfort, rash, sometimes itchy, hive-like rash (urticaria), low back pain (kidney pain), blood in the urine (hematuria)

Uncommon Side Effects That May Show Up In Blood Tests: reduction in the number of blood platelets which are cells that help blood to clot (thrombocytopenia), reduction in the number of white blood cells (leukopenia), increase in substances produced by the liver  

Rare (may affect up to 1 in 1,000 people): unsteadiness when walking and lack of coordination (ataxia), slow, slurred speech (dysarthria), fits (convulsions), altered brain function (encephalopathy), unconsciousness (coma), confused or disturbed thoughts (delirium)

These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valtrex a day. They usually get better when Valtrex is stopped or the dose reduced.

Other Rare Side Effects: kidney problems where you pass little or no urine.

Lastly, watch out for a severe allergy. It may be rare but it can be life-threatening so being aware of the symptoms is vital.

Severe allergic reactions (anaphylaxis): These are rare in people taking Valtrex. Anaphylaxis is marked by the rapid development of flushing, itchy skin rash, swelling of the lips, face, neck, and throat—causing difficulty in breathing (angioedema), fall in blood pressure leading to collapse. If any of these occur, get emergency treatment immediately


Of Note: “When Valtrex is coadministered with antacids, cimetidine and/or probenecid, digoxin, or thiazide diuretics in patients with normal renal function, the effects are not considered to be of clinical significance. Therefore, when VALTREX is coadministered with these drugs in patients with normal renal function, no dosage adjustment is recommended.” (PDR)

Aprotinin: Aprotinin is cleared in the kidney as is Valacyclovir. Together, the risk to the kidney is increased.

Bictegravir; Emtricitabine; Tenofovir Alafenamide: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.  

Cimetidine: Cimetidine may slow how quickly valacyclovir is cleared out of the body through the kidney but no dosage adjustments are recommended for patients with normal renal function.

Cobicistat; Elvitegravir; Emtricitabine; Tenofovir
Alafenamide: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Efavirenz; Emtricitabine; Tenofovir: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Emtricitabine; Rilpivirine; Tenofovir alafenamide: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Emtricitabine; Tenofovir alafenamide: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Emtricitabine; Tenofovir disoproxil fumarate: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Entecavir: Entecavir can affect kidney function and should be used cautiously with valacyclovir.

Fosphenytoin: Phenytoin and fosphenytoin are anti-seizure medications. The addition of valacyclovir to phenytoin may lead to a clinically significant decrease in phenytoin serum concentrations and loss of seizure control. Adjustments in phenytoin or fosphenytoin dosing should be considered if Valacyclovir is added or stopped when a patient is on either phenytoin and fosphenytoin.

Hyaluronidase, Recombinant; Immune Globulin: Immune Globulin (IG) products can damage the kidney. If they take any other drug that can affect the kidney, including valacyclovir, the dose of IG may need to be lowered and the infusion rate slowed.

Immune Globulin IV, IVIG, IGIV: Immune Globulin (IG) products can damage the kidney. If they take any other drug that can affect the kidney, including valacyclovir, the dose of IG may need to be lowered and the infusion rate slowed.

Lamivudine; Tenofovir Disoproxil Fumarate: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) If possible, discontinue valacyclovir at least 24 hours before administration of the varicella-zoster virus vaccine, live. Also, do not administer valacyclovir for at least 14 days after vaccination. The medication might have the unintended effect of diminishing the protective benefit of the vaccine.

Mycophenolate: (Moderate) Valacyclovir, when added to MMF, cyclosporine, and prednisolone caused a decrease in White Blood Cells, called neutropenia. When this combination must be used careful blood monitoring is recommended.

Phenytoin: Phenytoin is an anti-seizure medication. The addition of valacyclovir to phenytoin may lead to a clinically significant decrease in phenytoin levels and loss of seizure control. Adjustments in phenytoin dosing should be considered if valacyclovir therapy is added or discontinued.

Probenecid: Probenecid can reduce the kidney’s clearance of valacyclovir causing an increase in the blood level of valacyclovir. In the absence of a decrease in renal function, no dose adjustment is needed.

Talimogene Laherparepvec: “Consider the risks and benefits of treatment with talimogene laherparepvec before administering acyclovir or other antivirals to prevent or manage herpetic infection. Talimogene laherparepvec is a live, attenuated (lessened capacity to cause disease) herpes simplex virus that is sensitive to acyclovir; coadministration with antiviral agents may cause a decrease in efficacy.”

Telbivudine: Valacyclovir can affect kidney function. Since telbivudine is also cleared by the kidney, monitoring kidney function before and during telbivudine treatment is recommended.

Tenofovir Alafenamide: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Tenofovir Alafenamide: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Tenofovir, PMPA: Tenofovir is primarily excreted via the kidneys, as is valacyclovir, so Tenofovir should not be used if a patient is on valacyclovir or has been on it recently.

Varicella-Zoster Virus Vaccine, Live: (Major) If possible, discontinue valacyclovir at least 24 hours before administration of the varicella-zoster virus vaccine, live. Also, do not administer valacyclovir for at least 14 days after vaccination. The medication might have the unintended effect of diminishing the protective benefit of the vaccine.


Sours: https://www.getroman.com/genital-herpes/valacyclovir-500mg/

Dose daily valtrex

Valacyclovir for Episodic Treatment of Genital Herpes: A Shorter 3-Day Treatment Course Compared with 5-Day Treatment

Abstract

Valacyclovir given in a 5-day regimen of 500 mg twice per day is effective as short-term treatment of episodes of recurrent genital herpes. This study compared the efficacy of a shorter, 3-day course (for 402 patients) with that of a 5-day course (for 398 patients) of valacyclovir for persons with frequent recurrence of symptoms. No significant differences were detected between the 2 dosing schedules for any of the end points measured. Median times to lesion healing, of pain duration, and of episode length for the 5-day versus 3-day treatment were 4.7 versus 4.4 days, 2.5 days versus 2.9 days, and 4.4 days versus 4.3 days, respectively. The proportions of patients with aborted lesions were 26.6% and 25.4% in the 5-day and 3-day groups, respectively. A 3-day course of 500 mg of valacyclovir administered twice daily as episodic treatment of recurrent genital herpes is equivalent to a 5-day course with regard to key markers of efficacy.

Genital herpes is one of the most prevalent sexually transmitted diseases in the world today: ∼1 in 5 adults in the United States is seropositive for herpesvirus type 2 (HSV-2) [1]. Although the disease itself is generally not life-threatening, it has significant morbidity and impact on patients' lives [2–4]. Presently, no cure is available for the condition, but treatment strategies are available to alleviate the acute symptoms of a herpes outbreak or to suppress recurrences.

Orally administered antiviral therapy for genital herpes is prescribed either to alleviate the acute symptoms and signs of an outbreak (i.e., episodic treatment) or to prevent the herpesvirus (HSV) reactivation and recurrent outbreaks (i.e., suppressive therapy). The specific aims of episodic treatment are to shorten the duration of the outbreak, reduce the severity of pain, and hasten lesion healing. Prompt treatment, starting within a few hours after the patient first detects symptoms of an outbreak, can halt the process of vesicular lesion development (i.e, aborted lesions) [5, 6].

Valacyclovir, the l-valine ester of acyclovir, is widely used to treat genital herpes, both as episodic therapy administered twice daily and as suppressive therapy administered once daily. In controlled, randomized trials using lesion healing, pain, and HSV shedding as measures of clinical efficacy for 5 days, valacyclovir has been shown to be as effective as orally administered acyclovir (200 mg 5 times daily) as episodic treatment for genital herpes recurrences [7].

This double-blind, controlled study compared the efficacy and safety of a 5-day regimen of valacyclovir (500 mg b.i.d.) with a 3-day regimen of valacyclovir (500 mg b.i.d.) for the treatment of a single recurrent genital herpes episode. If a 3-day course of treatment is equivalent in efficacy to the 5-day course, then the reduced therapy duration could increase convenience to patients who prefer discreet, episodic medication regimens and could reduce the cost of treatment.

Patients and Methods

Study design. This study was a randomized, double-blind comparison of the efficacy of valacyclovir administered orally for 5 days versus 3 days in the treatment of a single recurrent genital herpes episode in otherwise healthy adults. It was conducted at 48 medical centers, including 34 medical centers in the United States and 14 in Canada. The study protocol was approved by the institutional review board at each study site. A flow chart of the study is shown in figure 1.

Figure 1

Flow chart of participants and treatment completed in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes.

Figure 1

Flow chart of participants and treatment completed in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes.

Written informed consent was obtained from patients, who were then screened for eligibility on the basis of the findings of a medical history, physical examination, and blood testing. Patients enrolled in the study were given a 3-day supply of open-label valacyclovir (500 mg b.i.d.) and instructed to self-initiate treatment no later than 24 h after the first sign or symptom of a recurrence of their genital herpes. They were asked to return to the clinic within 24 h of initiating treatment. At this initial visit to the clinic for a treated recurrence, patients were stratified by sex and randomized into the 2 blinded treatment groups and provided with 2 additional days' worth of either valacyclovir (500 mg) or placebo.

Patients were asked to maintain a daily diary to record data regarding lesion stages (prodromal, macule/papule, vesicle/pustule/ulcer, crust, or healed), pain severity (none, mild, moderate, or severe), adverse events, concomitant medications, and compliance with the study drug regimen. Patients were evaluated in the clinic daily for 6 consecutive days and, if necessary, twice per week thereafter, until all lesions were healed and clinical symptoms were absent. Clinical assessments included review of the diary information and an assessment of lesion stages by the investigator. The investigator was permitted to override patient diary data that were inconsistent with clinical findings.

Patients. Participants in this study were patients aged ⩾18 years who were otherwise healthy and who had a history of ⩾4 episodes of genital or perianal HSV outbreaks in the previous year or 2 episodes in the previous 6 months. Confirmation of genital HSV infection was required for study entry. Confirmation could be done by means of culture, direct antigen detection tests, Tzanck smears, immunofluorescence assays, or be means of a written confirmation by a primary-care doctor. Patients who received suppressive therapy with acyclovir during the 12 months before the study were eligible if they had experienced ⩾1 recurrence within 3 months after discontinuation of therapy and within 3 months before study entry.

Patients were excluded if they were currently receiving probenecid, had received systemic antiviral treatment in the 7 days before the first dose of the study drug, or had received an investigational drug or immunomodulatory treatment in the 30 days before receiving the study drug. Immunocompromised patients, those with known HIV infection, and those with renal impairment (creatinine clearance, ⩽30 mL/min) or hepatic impairment (⩾5-fold increase in alanine transaminase level above the normal upper limit) were also excluded from the study, as were persons with a history of hypersensitivity to acyclovir. Other patients excluded from the study were pregnant women, nursing mothers, and sexually active women of childbearing age who were not using an effective and acceptable method of contraception (i.e., oral contraceptives, diaphragm, condoms, or an intrauterine device).

Efficacy end points. The primary end point of the study was the time to lesion healing, which was measured as the number of days from initiation of therapy to reepithelialization of all lesions. Patients whose lesions aborted or who had clinical symptoms but who did not develop lesions were excluded from the analysis of the primary end point.

The secondary end point of this study was duration of pain, measured as the number of days from initiation of treatment or start of pain or discomfort (whichever was later) to the complete cessation of pain. Other secondary end points included length of the episode and the occurrence of aborted lesions. The length of episode was measured as the number of days from initiation of treatment to complete resolution of all signs and symptoms. All patients, including those with aborted lesions, were included in this analysis. Patients whose lesions aborted were defined as those whose lesions did not progress beyond the macule/papule stag, or as those who had clinical symptoms, such as pain, but who did not develop lesions.

Statistical analysis. The intent-to-treat population was defined as all randomized patients. It was presumed that ∼30% of treated patients would not develop lesions and, thus, would not be included in the analysis of the primary end point (i.e., time to lesion healing).

The distributions of times to lesion healing, cessation of pain, and cessation of all symptoms and signs were estimated by the Kaplan-Meier product-limit method. Equivalence in time to lesion healing, duration of pain, and length of episode was assessed by a 95% CI for the Hodges-Lehman estimate of the treatment difference. A difference of <20% from the median time to event for the 5-day regimen was not considered clinically significant. The 400 treated patients per study group provided µ80% power to establish equivalence.

Hazard ratios and 95% CIs were calculated for each time-to-event end point by use of Cox's proportional hazard models, controlling for the patients' sex and the analysis center. The validity of the proportional hazard model (the hazard ratio did not change with time) was checked by plotting the log of the negative log of the survival distributions against time. The Cochran-Mantel-Haenszel test was used to test for treatment differences in proportions of patients with aborted lesions, adjusting for the patients' sex and analysis center.

Results

A total of 1170 patients were enrolled in the study, of whom 800 were randomized to receive the 5-day regimen of valacyclovir (398 patients) or the 3-day regimen of valacyclovir followed by placebo on days 4 and 5 of treatment (402 patients). The majority of the 370 patients enrolled but not randomized did not experience a genital herpes recurrence during the study period. Of those randomized, 362 (91%) of 398 patients in the 5-day group and 359 (89%) of 402 patients in the 3-day group completed the study (figure 1). In each treatment group, the majority of patients who did not complete the study (31 patients in the 5-day group and 35 patients in the 3-day group) discontinued the study as a result of a protocol violation. The other persons who did not complete the study did not return for follow-up visits or voluntarily withdrew from participation.

Demographic and disease characteristics of randomized patients are presented in table 1. Compliance with dosing was high: 99% of patients were reported to have continued use of the study medication until the end of the dosing period.

Table 1

Demographics and disease characteristics of randomized patients in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes.

Table 1

Demographics and disease characteristics of randomized patients in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes.

Efficacy. In the intent-to-treat analysis, the median time to lesion healing (table 2) was 4.7 days in the valacyclovir 5-day group (292 developed lesions) and 4.4 days in the 3-day group (299 developed lesions). The Kaplan-Meier plot for lesion healing is illustrated in figure 2. No significant differences in time to lesion healing were noted between treatment groups by either method of analysis.

Table 2

Median time to event efficacy end points, with Hodges-Lehman estimates of treatment differences and 95% CIs for differences, in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes.

Table 2

Median time to event efficacy end points, with Hodges-Lehman estimates of treatment differences and 95% CIs for differences, in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes.

Figure 2

Time to lesion healing in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes. Hazard ratio, 0.95; 95% CI, 0.81–1.13; P = .59.

Figure 2

Time to lesion healing in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes. Hazard ratio, 0.95; 95% CI, 0.81–1.13; P = .59.

The duration of pain and length of episodes were similar in both treatment groups, with no significant differences between persons who received the 5-day and 3-day dosing regimens for either end point (table 2). To satisfy the proportional hazard assumption, the patients' sex was included in the Cox model as a stratification variable for duration of pain and as a covariate for length of episode. In men, the median duration of pain was 2.0 days for the valacyclovir 5-day group and 2.4 days for the valacyclovir 3-day group. The difference in duration of pain was not statistically significant (P = .2563). Because the 95% CI is 20% of the 5-day group's median duration of pain, the 2 regimens are considered to be equivalent. Women experienced a longer duration of pain, with a median duration of 2.9 days for the valacyclovir 5-day group and 3.0 days for the valacyclovir 3-day group. (P = .0773; table 3). For length of episode, the effect of the patients' sex in the Cox proportional hazard model was statistically significant (hazard ratio, 0.81; 95% confidence limits, 0.70, 0.95).

Table 3

Median duration of pain for persons enrolled in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes.

Table 3

Median duration of pain for persons enrolled in a comparative study of 3- and 5-day regimens of valacyclovir for the episodic treatment of genital herpes.

Prevention of lesion progression beyond the macule/papule stage (i.e., progression to aborted lesions) was reported by ∼26% of patients. No differences were detected between the valacyclovir 5-day and valacyclovir 3-day treatment groups (26.6% vs. 25.4%, respectively), as shown by an RR of 1.04 and 95% confidence limits of 0.83 and 1.32.

Safety. Adverse events that occurred during the study period were similar between treatment groups. The most common adverse events reported in the 5- and 3-day treatment groups were headache (in 10% of patients), nausea (in 4%), diarrhea (in 4% and 2%, respectively), and fatigue (in 1% and 2%, respectively).

Discussion

The results of this study indicate that a shorter 3-day course of valacyclovir is as effective as a 5-day course for the episodic treatment of recurrent genital herpes, with median durations to event end points similar to those for trials described elsewhere [5–7]. The previously recommended 5-day valacyclovir treatment regimen is based on the results of 2 controlled trials in immunocompetent patients with recurrent genital herpes [5, 6]. The clinical basis of testing a 3-day valacyclovir regimen for episodic treatment of recurrent genital herpes was the previous viral shedding data from a study of 5-day courses of valacyclovir (500 mg b.i.d.) [5]. For HSV culture–positive patients who received a 5-day regimen of valacyclovir, the median time to cessation of viral shedding was 2 days. Thus, it was theorized that maximum effect of valacyclovir on HSV is achievable within the first 3 days of treatment, which is consistent with the mode of action of acyclovir in inhibiting virus replication. Virologic evidence of 3- and 5-day equivalence can be inferred on the basis of a similar trial in Europe [8], in which 531 patients with recurrent genital herpes were randomized to receive valacyclovir (500 mg b.i.d.) for either 3 or 5 days. The median times to cessation of viral shedding for patients with a positive HSV culture result immediately before starting treatment for 3 or 5 days were similar (1.7 vs. 1.8 days, respectively), which replicates earlier findings [5].

The results of our study demonstrate that a shorter 3-day treatment course with valacyclovir is clinically equivalent to a 5-day course for the episodic treatment of recurrent genital herpes. In this study, a trend toward longer duration of pain was seen in men who received the shorter course of therapy. Although almost statistically significant, the magnitude of the difference is small and almost certainly not clinically relevant. In clinical situations in which patients exhibit pain as well as other clinical evidence of delayed healing after receiving 3 days of therapy, an additional 2 days of therapy may prove to be beneficial. In addition to the convenience of a shorter course of treatment, a 3-day regimen has the benefit of a 40% decrease in the amount of drug and may result in a 40% reduction in the drug price of a prescription. Whether the patient or insurance company sees a full 40% reduction in prescription price would involve tablet quantity, prescription fees, and other aspects of filling a prescription.

Study Group Members

Participating investigators included the following persons: Fred Aoki, Winnipeg, Manitoba; Karl Beutner, Vallejo, CA; Ronald Castellanos, Fort Myers, FL; Robert Cesarec, Wauwatosa, WI; Scott Clark, Longmont, CO; Loretta Davis, Augusta, GA; Francisco Diaz-Mitoma, Ottawa, Ontario; Frank Dunlap, Tucson, AZ; Kenneth Fife, Indianapolis, IN; Gumaro Garza, McAllen, TX; Harold Guy, San Diego, CA; David Haase, Halifax, Nova Scotia; H.

Acknowledgments

We thank Mike Colopy for performing statistical analysis.

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Sours: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC149313/

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Below, we’ve listed common valacyclovir dosages for a variety of conditions, such as outbreaks of oral or genital herpes. The dosage information provided below is for adults -- for children, you should consult your doctor, who will provide dosing recommendations based on your child’s age, weight and health.

Note: If you have been prescribed valacyclovir by your doctor to treat any condition, follow the dose and frequency they recommend. The information below is provided as a reference only -- you should always follow your doctor’s advice when using any prescription medication.

Valacyclovir Dosage for Cold Sores (Oral Herpes)

Oral herpes is the most common form of the herpes virus, affecting approximately two thirds of all people aged 14 to 49.

Valacyclovir is highly effective at treating oral herpes. Taken early in the formation of a cold sore, repeated use of valacyclovir over the course of one day can reduce the amount of time required for a cold sore to heal.

The typical dose of valacyclovir used to treat cold sores is 2,000 mg, with a secondary dose of 2,000 mg within 12 hours. This repeated, high dose of valacyclovir quickly ends viral replication and allows cold sores to heal one to two days faster than normal.

Valacyclovir Dosage for Genital Herpes

If you have genital herpes, you’ll understand how stressful an outbreak can be. People infected with genital herpes can experience four to five outbreaks of the virus per year, making it vital to have medication like valacyclovir on hand in the event you notice herpes lesions developing.

Like oral herpes, valacyclovir is highly effective at treating genital herpes and speeding up the healing process.

Genital herpes occurs in two phases. After being infected with the virus, most people will have an initial outbreak -- a powerful outbreak of the virus that can result in severe symptoms. After this, genital herpes presents itself in recurring outbreaks every few months.

The typical dose of valacyclovir used to treat an initial outbreak of genital herpes is 1,000 mg taken two times per day. This twice-daily 1,000 mg dosage usually continues over 10 days as the herpes outbreak retreats and the lesions close, scab and heal.

During a very severe initial outbreak of genital herpes, your doctor might recommend taking valacyclovir over a longer period.

For recurring genital herpes, the typical dosage of valacyclovir is 500 mg taken twice daily for three days.

As with cold sores, valacyclovir is most effective at treating genital herpes when it’s taken as early as possible during an outbreak. Taken early, consistently and at the right dose, use of valacyclovir can make dealing with a difficult genital herpes outbreak more manageable.

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Some keep their breakouts at bay with a once daily pill. Connect with a healthcare provider and discover your treatment options.

Valacyclovir Dosage for Shingles

Valacyclovir is also used to treat shingles -- a painful form of herpes skin rash caused by the varicella zoster virus.

The standard dose of valacyclovir used to treat shingles is 1,000 mg taken three times every day. Valacyclovir treatment for shingles usually goes on for seven days, although your doctor may recommend continuing valacyclovir if your symptoms are slow to improve.

Just like with cold sores and oral herpes, valacyclovir is most effective when it’s taken as early as possible after noticing shingles symptoms. It’s recommended to begin using valacyclovir in 72 hours or less after noticing signs of a shingles outbreak.

Valacyclovir is also used to treat recurrent outbreaks of shingles. These are extremely rare and tend to occur in people with weakened immune systems due to conditions such as leukemia or HIV, or the use of immunosuppressive medications.

Valacyclovir Dosage for Suppressive Therapy

Finally, valacyclovir is also used for suppressive therapy -- a method of reducing the risk of an infected person spreading herpes to their partner or family members, as well as restricting the ability of the virus to cause frequent outbreaks.

The standard dose of valacyclovir for suppressive therapy is 1,000 mg taken once daily. People with HSV-1 or HSV-2 that only experience infrequent outbreaks may also be prescribed a lower dose of 500 mg per day.

Talk to Your Doctor Before Using Valacyclovir

Overall, valacyclovir is an extremely safe, well-studied medication. Its side effects are mild and rare, affecting only a small percentage of users. It’s also very safe for the liver and other internal organs, including those commonly affected by other medications.

However, it’s important to speak to your doctor before taking valacyclovir to treat any infection, including herpes. It’s particularly important to speak to your doctor before using valacyclovir if you have HIV or any other health condition that can cause reduced renal or immune function.

Learn More About Valacyclovir

Valacyclovir is an affordable, highly effective antiviral medication, making it the “gold standard” for treating outbreaks of herpes and reducing the risk of infecting others with the virus.

Our Valacyclovir 101 guide covers the ins and outs of valacyclovir in more detail, from how the drug works to reduce the spread or herpes and treat outbreaks to the potential side effects you may experience while taking valacyclovir to treat herpes.

Sours: https://www.forhims.com/blog/valacyclovir-dosage-guide-cold-sores-genital-herpes-more


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