New Drug Application « From Eternity To Here

Today’s HIV News shelf is crowded. Two stories on the HIV front involve good news about early HIV treatment and Pre-Exposure Prophylaxis(PrEP) to reduce infection rates among high-risk persons.

A study (popularly known as the Setpoint Study) finds that people newly-infected with HIV-1 who immediately start anti-retroviral therapy are more likely to have beneficial medical outcomes than those who wait until CD4 counts fall below medically acceptable levels (currently 350-500 depending who you talk to).

“This is very welcome news,” said Frank J. Oldham, NAPWA President and CEO. “The study supplies scientific confirmation of something we at NAPWA have always believed: the closer we can come to bringing all people living with HIV into treatment, and the earlier they start treatment, the better. We already knew this is true for populations as a whole: more and earlier treatment means fewer new infections. Now we know that – on the whole – it’s also better for individuals already infected.”

The news on the HIV front just keeps getting better. The setpoint study follows on the heels of a groundbreaking study which provides proof of HIV treatment as prevention: HIV-infected persons on medication with undetectable viral levels are 96% less likely to pass on the virus.

It also accompanies Gilead’s application to offer Truvada as the first drug marketed to prevent HIV:

Gilead Sciences Inc. announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA)for the approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP. The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP, sponsored by the U.S. National Institutes of Health (NIH) and the University of Washington. Several other clinical studies support the use of Truvada for HIV risk reduction.

“The data from these large-scale clinical trials suggest that Truvada may have a role to play in meeting the urgent public health need to reduce new HIV infections,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. “Gilead is proud to have played a part in helping to define the use of Truvada as a potential new prevention tool and we commend the many institutions, investigators and study volunteers for their commitment to advancing this important area of research.”

Truvada is not currently labeled to reduce the risk of infection, it is labeled only for HIV treatment.

This could be an important step in slowing HIV. Around 50,000 people are still being infected with HIV every year in the U.S. according to the CDC. More than half of new infections (61%) occur among men who have sex with men, and nearly a quarter (23%) occur among women.

If Truvada can be given to high-risk persons (which includes negative partners in a sero-discordant relationship) and insurance companies will pay for it, it may, along with the groundswell of early treatment science, start a trend of slowing the progression of HIV in this country.

But only if we can get more high-risk people in for testing and treatment….

When was your last HIV test?