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Combination emtricitabine/tenofovir disoproxil fumarate provided partial protection against HIV in MSM
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Treatment with once-daily oral emtricitabine plus tenofovir disoproxil fumarate led to partial protection from HIV infection in men and transgender women who have sex with men, according to new findings from the Pre-exposure Prophylaxis Initiative.
For the placebo-controlled, double blind, randomized trial, Robert M. Grant, MD, MPH, associate professor of medicine at the University of California, and colleagues evaluated pre-exposure prophylaxis with emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) combination therapy in single tablet form in 2,499 HIV-seronegative men and transgender women who have sex with men.
“With 2.6 million new HIV infections occurring last year alone, the need for new HIV prevention tools is enormous, and we hope and believe that oral [pre-exposure prophylaxis] can become one of those tools,” Grant told Infectious Disease News.
Participants were randomly assigned to receive the combination drugs or placebo once-daily. Participants were followed for 3,324 person-years (median, 1.2 years; maximum, 2.8 years).
Ten participants had HIV at baseline; 100 became infected during follow-up (36 in the FTC–TDF group and 64 in the placebo group).
The combination therapy drug was detected in 51% of seronegative participants and in 9% of HIV-infected participants (P,.001). The researchers noted that nausea was reported more frequently during the first 4 weeks in the combination therapy group than in the placebo group (P,.001). Both groups had similar rates for serious adverse events (P=.57).
In an accompanying editorial, Nelson L. Michael, MD, PhD, of the US Military HIV Research Program, discussed the need for better preventive treatments. “The results of the [Pre-exposure Prophylaxis Initiative] study represent a significant advance in HIV-prevention research in providing the proof of concept that a combination antiretroviral drug in widespread clinical use in the treatment of chronic HIV infection reduces the risk of HIV acquisition in men who have sex with men,” Michael said.
Grant said an open-label phase of [Pre-exposure Prophylaxis Initiative] will start early in 2011 and will seek better ways to foster protective behavior among [pre-exposure prophylaxis] uses, including condom use, communication with partners and [pre-exposure prophylaxis] pill use.
Co-formulated emtricitabine/tenofovir is marketed under the name Truvada by Gilead in the US and is available for HIV treatment in many countries.
For more information:
- Grant RM. N Engl J Med. 2010;doi:10.1056/NEJMoa1011205.
- Michael NL. N Engl J Med. 2010;doi:10.1056/NEJMe1012929.