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EXPERTS CALL FOR ACTION IN PREVENTING HERPES AMONG NEWBORNS
About one in four pregnant women has genital herpes, and as many as 90% are undiagnosed. In most cases, genital herpes is a recurrent infection that rarely causes problems or complications. However, if a newborn contracts the virus at birth (neonatal herpes), untreated infection in newborns can progress to irreversible brain damage, heart and liver damage, and other complications.
A commentary in the September 2005 issue of the journal Sexually Transmitted Diseases estimates between 460 and 2,800 cases of neonatal herpes occur each year in the United States. Authors of the article point out that even the lowest current estimate of neonatal herpes exceeds the rates of several other conditions. Congenital rubella, HIV infection, syphilis, and gonorrhea in newborns are all less common than neonatal herpes – yet all are reportable diseases in almost all states and tracked by the Centers for Disease Control and Prevention (CDC).
Without treatment, neonatal herpes is fatal in at least half of cases and up to two-thirds of survivors have lifelong disabilities. Yet in the medical field, neonatal herpes gets little attention and is likely under-reported.
“Early diagnosis and treatment of infected infants is critical,” says James R. Allen, MD, MPH, president and CEO of the American Social Health Association. “This article points out that relatively little is known about how frequently this infection occurs in the United States and about the outcomes of the infected babies. We need to increase awareness of this problem by collecting better data and assuring that health care providers have current information.”
“Few conditions can match the havoc caused by neonatal herpes in its impact on affected families,” says H. Hunter Handsfield, MD, lead author of the article. Among those diagnosed with genital herpes, fear of passing the infection to children is among the leading concerns. And parents of children who have been afflicted with neonatal herpes often advocate for more concerted prevention efforts.
One such parent is Barbara Peabody Beattie, who has worked with ASHA’s Herpes Resource Center to raise awareness of the problem. “Women must be made aware, through education, of the consequences of passing the virus to a newborn, “ says Beatty. “I was not aware I was infected with herpes simplex, and I wasn’t offered testing. I wish my story was the only one out there, but there are many others, and the number of children affected is increasing. We urgently need to figure out how to prevent this from happening.”
One step in addressing neonatal herpes is to urge states and public health agencies including the CDC to include the condition in their list of reportable infections. Only seven states currently mandate reporting of neonatal herpes: Ohio, Florida, North Dakota, Washington, Connecticut, Massachusetts, and Nebraska.
“[Herpes] probably is the most frequent of all serious, yet preventable and treatable, perinatal or congenital infections,” the authors of the commentary contend. “However, it is sufficiently uncommon that reporting would pose little incremental administrative burden on healthcare providers or health departments.” Case reporting would provide reliable data on the incidence and impact of the disease to inform prevention efforts, clinical guidelines, and health policies.
Genital and neonatal herpes have long been considered difficult to prevent and difficult to identify. However, significant diagnostic and treatment advances have been made in recent years, and some experts believe it’s time for a more deliberate prevention effort.
Control strategies to date have focused on women with a history or evidence of genital herpes, despite data showing that two-thirds of infected infants are delivered to women with no history or clinical evidence of the disease. Newer FDA-approved serologic tests can aid in identifying women who have herpes but are unaware of it, as well as women at risk of acquiring herpes during pregnancy. Looking ahead, today’s research pipeline also includes a potential vaccine for herpes simplex virus type 2, the cause of most genital herpes.
The commentarys other authors are: Zane A. Brown, MD, a professor of obstetrics and gynecology at the University of Washington and an authority on herpes in pregnancy; Lawrence Corey, MD, a herpes and HIV vaccine expert at the Fred Hutchinson Cancer Research Center and University of Washington; Joan L. Drucker, MD, of Medika LLC; Charles W. Ebel, of the American Social Health Association; Peter A. Leone, MD, an associate professor of medicine at the University of North Carolina; Lawrence R. Stanberry, MD, PhD, a professor of pediatrics at the University of Texas Medical Branch in Galveston; Ann Waldo, JD, a lawyer formerly with GlaxoSmithKline; and Richard J. Whitley, MD, a professor of pediatrics and an expert in neonatal herpes at the University of Alabama at Birmingham.
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HIGH DOSE VALACYCLOVIR REDUCES VIRAL SHEDDING IN PATIENTS WITH COLD SORES
Those who have cold sores and worry about the risk of transmitting HSV-1 may be keenly interested in the latest findings on valacyclovir. New research presented in New Orleans at the 63rd annual meeting of the American Academy of Dermatology in February 2005 showed that one day of high-dose oral valacyclovir significantly decreases the duration of viral shedding that occurs with recurrent herpes labialis (cold sores) and may reduce the risk of transmission.
“We have new information that says valacyclovir will reduce shedding and transmission in these patients “said Stan Gilbert, MD, clinical instructor at the University of Washington in Seattle at a poster session during which the results of a University of Washington study were presented. The study showed that prescribing four doses of 500 mg valacyclovir caplets reduced the number of days on which viral shedding occurred (from 4.0 days for patients on placebo to 1.8 days for patients on high-dose valacyclovir) as well as the proportion of days of shedding (from 40 percent in the placebo group to 17.5 percent for the treatment group). The patients enrolled in this trial had at least three outbreaks per year with an average of four to five cold sores during the past year.
Commenting on the study’s results, Professor of Surgery at Georgetown University in Washington and the chairman of the meeting’s poster session, Michael Azsloff, MD, PhD, pointed out that, “If a physician is concerned about the spreading of the virus from man to woman or parent to child, then one-day, high-dose valacyclovir could reduce the chances of that,” he said.
20 to 40 percent of adults worldwide deal with recurrent cold sores and while a one-day, high-dose regimen of oral valacyclovir has proven to be effective in shortening the duration of cold sores, until now, little has been known about the drugs ability to impact oral viral shedding. As was outlined in the previous new story, people are usually infected with HSV-1 as kids or young adults, and the virus remains in the nervous system. When the virus is reactivated, viral shedding occurs and HSV-1 then can be transmitted to others. Although HSV-1 is most commonly associated with cold sores, it is now the most common HSV type linked to genital herpes. “Most new cases of genital herpes are type one,” said Dr. Gilbert. “Most are picked up from type 1 virus shed from the mouth during oral/genital sex,” he noted.
While many people simply don’t like the appearance of cold sores and are relatively unconcerned about the transmission of the virus to others, Dr. Gilbert suggested that both patients and physicians should consider and discuss transmission and treatment. “Any patient who is worried about transmission from recurrent cold sores now can be told that treatment with valacyclovir can shorten the time period of infectivity, and, therefore, the risk of transmission,” he said.
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IS HSV-2 SCREENING ETHICAL WHEN THERE ARE NO SYMPTOMS?
Many experts recommend expanded testing for herpes simplex virus type-2, as accurate blood tests for the virus are now widely available. Some go so far as to recommend herpes screening for any and all people wondering if they have an STD, but who don't necessarily have symptoms. However, a group of Swedish herpes researchers and medical ethicists published an article in the September 2005 issue of the British Medical Journal which asked, "Can screening be ethical when false positive results occur, many infected people are asymptomatic, and no cure is available?" Their answer was no.
Using an ethical model to consider and evaluate the positives and the negatives of universal herpes screening at the individual and public health levels, Professors Ingela Krantz, a specialist in infectious diseases, Gun-Britt Löwhagen and Beth Maina Ahlberg, members of a herpes research network in western Sweden, and Tore Nilstun, a medical ethicist, carefully and thoroughly map out the testing debate. First, they explore how testing is often positioned as a primary means of preventing transmission by identifying those people who don't know that they have HSV-2, the virus linked to the majority of genital herpes infections.
Those who support widespread or universal HSV-2 screening often argue that, as herpes is most often transmitted by those who don't know that they have the virus, those people who visit a clinic or health care provider seeking treatment for what they suspect to be an STD have a right to be tested for genital herpes. Regardless, these researchers feel strongly that the negatives of widespread or universal testing for genital herpes may simply outweigh the positives. They write, "One of the strongest arguments against such opportunistic screening is the possible psychosocial and psychosexual effects on asymptomatic people of discovering that they have a disease that is sexually transmissible, incurable, and life long."
The researchers go on to note that, at this time, there are just too many ethical deliberations to advocate universal screening for HSV-2. While the commercially available tests for herpes are relatively accurate, some risk of false positive results remains. They also point out that prevalence of genital herpes varies according to age and geographical locations (while numbers in the U.S. are on the rise, the number of genital herpes cases in Europe appear to be falling). Moreover, the fact that an infection with HSV-2 is typically asymptomatic but incurable, leads them to the conclusion that individuals must be free to decide what they feel is best for them when it comes to testing for genital herpes. Before universal screening for asymptomatic HSV-2 could really be effective, or ethically justified, they argue that patients must feel more comfortable with the information available about genital herpes provided by doctors and health care providers. In addition, the researchers conclude that patients, “must also be convinced that reasonable societal support will be available and affordable for those infected with HSV-2 as well as for their partners.”
While screening the general population for herpes may not be recommended, experts have specified certain situations, which do indeed warrant serologic herpes testing. Those situations include: those at high risk for STDs and HIV infection who want to reduce their sexual risk behavior, confirming herpes infection in individuals who have had symptoms but no positive confirmatory test results; determining if one is at risk for transmitting herpes to a sexual partner; detecting herpes as part of a comprehensive exam for individuals who want to know if they have an STD; and helping to determine a pregnant woman’s risk of passing herpes to a newborn.
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TO GET AN ACCURATE TYPE-SPECIFIC HSV-2 TEST, YOU HAVE TO PICK UP YOUR RESULTS: Those at highest risk for HSV-2 least likely to return for results
To visit a doctor or clinic for a type-specific HSV test is one thing, but for some, working up the courage to return for those results is quite another. Researchers J. Dennis Fortenberry, MD, MS, Gregory Zimet, PhD, and colleagues recently set out to examine how many people actually pick up their results, and what factors influence their return. Their findings were published in the November 2004 issue of Sexually Transmitted Diseases.
The researchers enrolled 820 people from a variety of testing sites, including a public STD clinic, two adult medical clinics, a health clinic for adolescents, and a college campus. They focused their efforts on sexually active men and women between the ages of 14 and 30 without a known history of genital herpes. Study participants received a type specific HSV-2 test and were asked to return for their results 2 weeks later. They also completed a true/false questionnaire to test their knowledge about genital herpes. Nearly 70 percent (578) of those enrolled in the study did show up to collect their results and receive post-test counseling -- but that leaves one-third who did not return for follow-up.
Researchers found that women and those who were on the older side of the age spectrum were more likely to return for their test results. Those who were well educated about genital herpes, and who perceived themselves to be at high risk for a sexually transmitted disease were also likely to pick up their results. People with more than one recent sexual partner were the least likely to return. Of all of the testing and recruitment sites, the public STD clinic had the lowest rates of return for test results.
Some researchers and public health advocates have positioned widespread type specific serologic testing (TSST), as one of the best ways to get a handle on the prevalence and prevention of genital herpes. However, for screening initiatives to really make an impact, those at risk must be tested, and receive their results, preferably in conjunction post-test counseling, which ideally includes emotional support along with treatment and prevention information. Unfortunately, the researchers found that while patients who were at the highest risk for genital herpes were quite willing to be tested, they were the least likely to return for their results -- a troubling factor for public health initiatives. The researchers hope their results will help guide the development of future testing programs. They note that the lower rates of return associated with high-risk patients make it all the more important to focus time and effort on stressing the importance of receiving test results and post-test counseling.
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HSV-2 COMMON IN ADOLESCENT GIRLS
A study of urban adolescents in the U.S. has shown that girls as young as 12 years old are likely to have a variety of HSV infections, including HSV-2, the virus typically linked with genital herpes. This lends more credence to the idea that an HSV-2 vaccine will need to be given to very young adolescents in order to be successful.
Working with colleagues from the University of Texas Medical Branch in Galveston, Susan Rosenthal, PhD, and Lawrence Stanberry, MD, PhD, found that seven percent of 174 12- to 15-year-olds tested at an urban health clinic had HSV-2. Following up with that same group three years later, they found that 14 percent had HSV-2. The researchers also discovered that over half of the young women carried HSV-1 and 81 percent had cytomegalovirus (CMV), another member of the herpes virus family. The results of this study, which add to research showing that HSV-1, HSV-2, and CMV are all extremely common infections, were published in the November 2004 issue of Clinical Infectious Diseases.
Interestingly, this study also examined whether HSV-1 may offer some natural protection from HSV-2. The researchers found that the girls with HSV-1 were less likely than those who did not have the virus to become infected with HSV-2.
Of course, as more research points to the increasingly widespread nature of HSV, the role of type-specific testing for HSV-2 becomes more important. Dr. Rosenthal also played a key role in a study published in the November 2004 issue of Sexually Transmitted Diseases examining whether adolescents and young adults will readily accept HSV-2 tests.
This study, led by Gregory Zimet, PhD, of the Indiana University School of Medicine, found that the majority (68.4%) of its 1199 participants were interested in and accepted type specific HSV-2 testing, even with no history of genital herpes symptoms. The researchers enrolled individuals aged 14 to 30 years old from a variety of testing sites, inviting them to complete a survey and receive a free HSV-2 test. They found that those who perceived themselves at a higher risk of HSV-2, women, and those who fell on the older side of the age spectrum were most likely to accept testing. Those with a fear of needles were least likely to accept testing.
Coupled with the previously mentioned research on the widespread prevalence of HSV, these results underscore the importance of educating adolescents and young adults about HSV along with preventative measures that they can use to protect themselves from infection early on. However, they do not indicate significant barriers to type-specific testing in this population.
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A COST EFFECTIVE MODEL FOR REDUCING NEONATAL HERPES
A new study, published in the December 2004 issue of the American Journal of Obstetrics and Gynecology indicates that testing pregnant women for HSV-2 and offering them antiviral therapy may be a cost effective way to decrease the incidence of neonatal herpes.
David Baker, MD, Zane Brown, MD, and researchers from the State University of New York at Stony Brook created a decision-tree model to determine the cost-effectiveness of providing type-specific testing 15 weeks into pregnancy and antiviral therapy from 36 weeks until the baby is born for women who test positive for HSV-2. To further reduce or eliminate a pregnant woman's risk of contracting genital herpes during her pregnancy -- which is the primary risk of neonatal herpes infection -- many recommend testing and treating her partner as well. Therefore, the researchers also looked at the theoretical cost effectiveness of offering testing and treatment to the partners of those women who test negative for HSV-2.
The researchers posit that type-specific testing coupled with antiviral therapy in pregnant women would result in an incremental cost per case of neonatal herpes avoided of $194,837. As other neonatal herpes management strategies, such as viral cultures in late pregnancy and cesarean deliveries for women with lesions or viral shedding at delivery, carry a higher price tag, this approach may be more cost effective. Offering testing and antiviral treatment to 100,000 pregnant women would cost $3.1 million dollars, and would result in 15.7 fewer cases of neonatal herpes and 186 fewer cesarean deliveries.
However, this model showed that testing and treating their partners was too expensive. While offering type-specific testing and suppressive therapy to both pregnant women and their partners could result in 16.8 fewer cases of neonatal herpes as well as 192 fewer c-sections, the $8.6 million price tag is out of the range considered to be cost effective.
In an interview with Reuters Health, Dr. Baker noted that further research is necessary, particularly on the effectiveness of suppressive therapy during pregnancy. Nevertheless, compared with no testing, testing pregnant women and providing those who are positive with antiviral therapy for HSV-2, "could decrease the incidence of neonatal herpes and reduce the number of cesarean deliveries performed," he said.
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ACYCLOVIR PREGNANCY REGISTRY OFFERS REASSURANCE
Because of limited data on the effects of acyclovir on unborn children, many have remained concerned about fetal exposure to acyclovir. The publication of the results of a 15-year study in the May/June 2004 issue of Birth Defects Research may provide reassurance. After reviewing data collected in the Acyclovir Pregnancy Registry, researchers found no unusual defects or pattern of birth defects resulting from pregnancies exposed to oral or intravenous acyclovir.
As acyclovir is so commonly prescribed, it makes sense that many sexually active women of childbearing age taking the drug may have done so without knowing that they were pregnant. The Acyclovir Pregnancy Registry was established in 1984 to track such inadvertent exposures and indicate any early signs of trouble to pregnancies or birth defects caused by acyclovir. BurroughsWellcome (now GlaxoSmithKline) set up and maintained the Registry for 15 years with an advisory committee made up of representatives from the Centers for Disease Control and Prevention (CDC).
From 1984 through 1998, 1,695 pregnancies exposed to acyclovir were voluntarily registered by the mothers' health care providers through a hotline and mailed questionnaires. Twenty-five percent of those were lost to follow up, but the researchers were able to monitor the outcomes of 1,234 pregnancies (which resulted in 1,246 babies, including 12 sets of twins) in 24 countries. The rates of birth defects in the children of those women who had taken oral acyclovir or been given IV acyclovir during the first trimester of their pregnancy were comparable to those in the general population, just 3.2 percent. Therefore, researchers concluded that the rates and types of birth defects seen in pregnancies exposed to acyclovir were not significantly different from those seen in the general population.
Acyclovir (Zovirax®) is available as an injection, ointment, capsule, tablet, and topical cream. It is commonly used to treat herpesvirus infections including herpes simplex and varicella zoster, the virus that causes chickenpox and shingles. Currently, acyclovir is not approved by the FDA for use in pregnancy. However, doctors do sometimes use acyclovir in the last trimester of pregnancy to reduce the chance of neonatal infection. The results of this study emphasize the safety of this widely used drug and may reassure those concerned about the effects of acyclovir during pregnancy. While the results from the Registry add to data indicating that the drug is safe for mother and child, be sure to talk to your health care provider if you are taking acyclovir and thinking of having a baby or suspect that you're already pregnant.
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MAKING THE CONNECTION BETWEEN HIV & GENITAL HERPES
More and more evidence is linking HIV and genital herpes, and researchers from the University of Washington, John Hopkins University, and the National Institute of Allergy and Infectious Diseases have taken note. After systematically reviewing available research from around the world documenting epidemiological, clinical, and biological connections between HIV and HSV-2, they have summarized the findings in in the March 2004 issue of the Journal of Acquired Immune Deficiency Syndrome.
Their analysis of research spanning from 1968 to 2002 shows that the prevalence of both HSV-2 and HIV are increasing and that HSV-2 plays a large role in the acquisition and transmission of HIV. Over 30 individual studies reviewed by the authors showed that HSV-2 significantly increases the risk of contracting HIV. In fact, a person with HSV-2 is two to four times more likely to contract HIV than a person without genital herpes. Additionally, the researchers saw striking evidence that HIV and HSV-2 interact with the other. Having genital herpes accelerates the affects of HIV and having HIV affects the course of genital herpes.
"We first started talking about and publishing on this connection in 1984," points out Larry Corey, MD, of the University of Washington " We're not trying to scare people," he says. " I think it's clear that in high risk groups, you can get HIV/AIDS without having herpes, but HSV is a fueler of the epidemic. There is a whole litany of data and there are more data coming out that herpes is and continues to be an issue of HIV."
Past data have shown that the majority of people with HIV also have HSV-2. Such co-infection, meaning that a person is infected with both HIV and HSV-2, can lead to more frequent and severe genital herpes outbreaks as well as in increase in herpes-related asymptomatic viral shedding. Moreover, it seems that both symptomatic and asymptomatic reactivation of HSV-2 can increase the frequency and amount of HIV viral shedding. This can increase the likelihood of HIV transmission should a person have unprotected sex with a partner.
On the treatment end, patients with HIV often have a difficult time treating genital herpes. The researchers here recommend daily suppressive therapy for treatment of HSV-2 in patients with HIV whenever possible to control genital herpes outbreaks and reduce viral shedding along with the risk of sexual transmission of both viruses to others.
According to information released during the 15TH International AIDS Conference in July 2004, over 38 million people worldwide are currently living with HIV and, despite prevention efforts, there are an estimated 40,000 new HIV infections every year in the U.S. alone. As the multiple links between HIV and HSV become increasingly clear, researchers are now calling for health care providers to pay particular attention to the diagnosis and treatment of genital herpes in HIV-positive individuals. While a vaccine would be the ideal way to break the link between herpes and HIV, suppressive antiviral therapy and practicing "safer sex" is an interim solution. Wearing a condom every time one has anal, vaginal, or oral sex, and suppressive antiviral therapy with valacyclovir have been clinically proven to reduce the likelihood of transmitting genital herpes.
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