Acyclovir Does Not Reduce Risk of HIV transmission, Study Finds
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Acyclovir Does Not Reduce Risk of HIV transmission, Study Finds

SEATTLE, Wash -- January 21, 2010 -- A 5-year international, multicentre trial has found that acyclovir does not reduce the risk of HIV transmission when taken by individuals co-infected with HIV and herpes simplex virus-2 (HSV-2). The results of the study are published early online and will appear in the February 4, 2010 issue of the New England Journal of Medicine.

Researchers had hoped that acyclovir’s ability to suppress the herpes virus could reduce the likelihood of sexual transmission of HIV from a person with HIV and HSV-2. The study is the first to determine whether twice daily use of acyclovir by individuals who are infected with both HSV-2 and HIV reduced the transmission of HIV to their sexual partners.

The authors concluded that daily acyclovir therapy did not reduce the risk of transmission of HIV, in spite of the fact that acyclovir reduced plasma HIV RNA by a 1/4 log and the occurrence of genital ulcers due to HSV-2 by 73%.

The Partners in Prevention HSV/HIV Transmission Study was conducted among 3,408 African HIV serodiscordant couples, in which 1 partner had HIV and the other did not. In all the couples, the partner who had HIV also had HSV-2 infection.

In the primary analysis of HIV transmissions determined by laboratory testing to have occurred within the couple and not acquired from an outside partner, there were 41 infections in the acyclovir arm and 43 in the placebo arm (not significant). Of the partners who were infected with HIV, 68 % were women.

Acyclovir suppressive treatment did show significant reductions in the frequency of genital ulcers (by 73%) and the average amount of HIV in the blood (by 0.25 log10 copies/milliliter, a reduction of 40%), compared with the placebo arm.

“As is often the case with large efficacy trials, you learn to expect surprises,” said lead author Connie Celum, MD, Global Health and Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington. “We found that, in spite of a significant reduction in plasma HIV levels and genital ulcer disease with acyclovir suppressive therapy, there was no reduction in HIV transmission. This was a disappointing finding, but a critical outcome of this study is the understanding that interventions must achieve a bigger reduction in HIV levels in order to reduce HIV transmission, especially among persons with high HIV levels. This will be important in informing future interventions to reduce HIV infectiousness.”

Dr. Celum said the study is a direct assessment of the impact of herpes suppression on HIV transmission and is the most direct way to see if it’s possible to make a person less infectious and less likely to transmit HIV to their partner. Although the primary outcome of reducing HIV transmission was not observed, Dr. Celum said the study achieved many significant milestones that will help to inform HIV prevention research in a number of ways. Among these were HIV testing of approximately 55,000 couples of unknown HIV serostatus, screening of more than 6,500 HIV serodiscordant couples, and enrollment of 3,408 couples in which the HIV- infected partner was dually infected with HSV-2 and not eligible for antiretroviral therapy, based on national guidelines.

The randomised, placebo-controlled, double-blinded study took place at 14 sites in 7 countries in eastern and southern Africa (Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda, and Zambia) and began recruitment in November 2004, with follow-up of participants ending in October 2008. Results were first announced in May 2009 and were presented at the International AIDS Society (IAS) meeting in Cape Town, South Africa, on July 22, 2009.

Both the placebo and treatment groups received standard HIV prevention services, which included being supplied with condoms, treated for other sexually transmitted infections, and provided care for HIV infection. All participants received extensive counseling, both individually and as a couple, throughout the study period, on how to reduce the risk of HIV infection.

SOURCE: University of Washington

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