Pediatric AIDS Foundation on Single-Dose Nevirapine
The Elizabeth Glaser Pediatric AIDS Foundation supports providing the safest, most effective regimen of drugs to prevent mother-to-child transmission in all instances. In the United States and other developed world settings, mother-to-child transmission has been dramatically reduced through aggressive prevention and treatment programs that are widely available. In the developing world, due to poor infrastructure and the high cost of other regimens, nevirapine, administered as one dose to the mother at the onset of labor and one dose to the child within 72 hours of birth, is frequently the only option feasible and available. There is considerable scientific data demonstrating that this short-course nevirapine regimen is safe and effective and should continue to be used to prevent mother-to-child transmission in settings where more complex regimens are not available.
The AP article raises concerns about the safety of short-course nevirapine for prevention of mother-to-child transmission. It is important to understand that there are no data demonstrating that significant NVP-induced toxicities occur in women or infants receiving short-course nevirapine for PMTCT. Although studies have shown a risk of toxicity with long-term use of nevirapine for HIV treatment, it is scientifically inaccurate to deduce harmful effects of a short-term course of nevirapine based on studies that examine long-term, continued use of the drug.
The single-dose nevirapine regimen to prevent mother-to-child transmission has been used in hundreds of thousands of women -- both in practice and in clinical trials -- without any significant toxicity for mothers or babies. Including the HIVNET 012 study, referenced in the AP article, single-dose NVP regimen has been studied in three large, randomized, comparative, phase III clinical trials including over 1,600 HIV-infected women and their infants. PACTG 316 was a phase III, randomized, double-blind clinical trial conducted in the U.S., Europe, Brazil, and the Bahamas. The South African Intrapartum Nevirapine Trial (SAINT) trial was a phase III, randomized trial comparing a combination of drugs to single-dose nevirapine. No significant clinical or laboratory toxicity was observed in any of these three studies. In addition, reports from clinicians administering this regimen in the field confirm what these studies demonstrated: that nevirapine, when taken in a short-course for PMTCT, does not cause significant toxicity in mothers or babies.
It is true that resistance has been shown to occur in those receiving short-course nevirapine. However, to date, there is no evidence of negative clinical outcomes as a result of subsequent antiretroviral therapy. The Foundation strongly supports further research about resistance issues. We are currently partnering with the Centers for Disease Control and Prevention to examine the long-term effects of a single dose of nevirapine for prevention of mother-to-child transmission on a woman's subsequent response to ARV therapies containing nevirapine. However, in the absence of evidence of negative clinical outcomes for future treatment, it would be premature to withdraw the only safe and effective regimen to prevent mother-to-child transmission of HIV that is currently available throughout large parts of Africa and other portions of the developing world.
UNAIDS estimates that 1,900 children worldwide are infected with HIV each day, the vast majority through mother-to-child transmission. Yet, services to prevent mother-to-child transmission are available to less than 10 percent of the women who need them. We must continue to work aggressively to expand access for pregnant women to scientifically-based services to prevent mother-to-child transmission and support research that will guide the very best implementation of these lifesaving programs. As one of the world's largest funders of PMTCT programs, the Foundation is committed to using the best available science to prevent as many infant infections as possible and safeguard the health of HIV-positive mothers.
In making any decision about drug regimen use, we should rely on the scientific facts. It would be premature and inappropriate to withdraw nevirapine as an option for mother-to-child transmission at a time when so many pregnant women throughout the world have no other option to save the lives of their babies. At this point in time, based on all existing scientific evidence, nevirapine should continue to be one of several interventions available to prevent mother-to-child transmission.
However, it is important to remember that safer, more effective drug regimens, including a combination of AZT and single-dose nevirapine and long-term combination therapy for the mother, exist and are already being used in some parts of the developing world. Rather than focus on withdrawing nevirapine from those who urgently need it, the entire world should focus on how we can provide the funding for infrastructure improvements, training, and drug purchase costs so that more and more women will have access to the most effective drug regimens possible. Ultimately, our goal must be for all pregnant women throughout the world to have access to the same drug therapy that is currently available in the United States and other developed nations. In the face of the worst pandemic of infectious disease in history, anything less than a full effort to save the lives of the next generation is a tragic avoidance of our fundamental responsibility.
This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.