HIV oral pre-exposure prophylaxis trial shows promise

January 18, 2011

The first trial to provide evidence that drugs used to treat HIV can also help to prevent HIV infection among men who have sex with men (when combined with other prevention strategies) was reported late November online in the New England Journal of Medicine.

The first trial to provide evidence that drugs used to treat HIV can also help to prevent HIV infection among men who have sex with men (when combined with other prevention strategies) was reported late November online in the New England Journal of Medicine.

The approach is referred to as pre-exposure prophylaxis, or PrEP.

The researchers found that when a once-daily dose of Truvada, a tablet containing 2 antiretroviral HIV medications-tenofovir and emtricitabine (TDF/FTC) was given to 2,500 HIV-negative gay men and transgender women who have sex with men, their risk of contracting the virus was slashed by 44%.

However, this number does not tell the whole story, as the majority of study participants who contracted HIV in the study had very low or no levels of the study drug in their systems, indicating possible noncompliance with daily administration.

Among a subset of study participants who did have detectable levels of TDF/FTC in their systems, the protective effect of PrEP rose to 92%.

Critical question of coverage

Since Truvada can cost as much as $14,000 per year in the United States, a crucial question is whether AIDS assistance programs, Medicaid, and/or insurance companies, will cover the drug. Institutional purchasers are often able to get the drug for less, and it is available generically in many countries with severe HIV epidemics for as little as 39 cents per day.

“CDC will fully review the trial data and publish interim guidance for physicians on the safe and effective use of PrEP in the coming weeks in the Morbidity and Mortality Weekly Report, to be followed by formal U.S. Public Health Service guidelines," according to a CDC spokeswoman.

“Coverage is one of the key real world issues that must be addressed as we move forward, “ she told Drug Topics. “CDC certainly believes that proven interventions should be available to those who need them.”

She said, “Recommendations would not be given for IV drug users until a trial studying this population is completed.”