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? Do they occur around the same time as your period? 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.

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 groom or bride on their wedding day, an applicant before a much-desired job interview, or an actor before an important audition. You don’t need to be an actor or getting married to want to prevent a cold sore. It could be that an outbreak would be uncomfortable during the holidays, before your high school reunion, or when you finally take that vacation in Aruba and want to sit in the sun a bit (yes, with lots of sunblock). It isn’t known precisely how to take the medicine in those circumstances but using the medication as prescribed the day or two before an interview, for example, seems logical.

It may also be reasonable to use the medication for the entire time that you want to avoid an outbreak (a weeklong vacation or holiday season, for example). Taking a low daily dose may prove useful in those circumstances. For these longer periods, the use of valacyclovir 500 mg once a day for up to four months has been studied and found effective in reducing (not eliminating) the number of outbreaks.

This low dose, daily regimen might also prove helpful for those who know outbreaks are more likely to occur during a particular time of year, like the summer or during a period of extended stress (physically or emotionally).

The logic of using medication to prevent oral outbreaks during times when they are more likely to occur is supported by the data obtained from patients having facial surgery. CO2 laser resurfacing of the face is complicated by the activation of herpes in patients getting this plastic surgery procedure. In one study, 120 patients received valacyclovir 500 mg twice a day for either 10 or 14 days starting the day prior to facial laser resurfacing and continuing for up to two weeks to cover the time needed to heal. No patient had a recurrence.

Using the medication, either 1 g/day (1,000 mg/day) or 500 mg twice/day would not be unreasonable for short periods, especially if undergoing a major procedure in the head and neck region or during periods when outbreaks might occur with near certainty.

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; renew your prescription as frequently as you feel is necessary. As long as it 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 provider, 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.

Herpes Information (oral and genital)

We recommend you read everything below. It is a summary of some of the information in the PDR and other sources. You should read the full package insert when it arrives with your medicine. You can access the PDR directly, as well. Keep all the information handy in case your medical status changes and you need to refer back to it.

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 herpes. 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 provider 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.

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), 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’s 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?

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 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. 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.

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

Worldwide (in 2012) nearly a 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.

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 heal within just a few days, 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 think 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.

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 herpes outbreaks 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.

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 think 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.

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

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. 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. However, the virus can still exit the nervous system and shed from the skin, even if you never have another outbreak.

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, and 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 fine. 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.

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 most of the people who become infected will have no symptoms (yet will be capable of transmitting the disease).

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 during pregnancy is an important issue and, of course, should be discussed in detail with your obstetrician for individual guidance.

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 on other parts of the body: 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. 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) in DNA—almost an identical copy. 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. 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.

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 7 to 10 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 10 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 provider.

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 directly to an emergency room. Otherwise, talk to your provider 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.

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.