FDA just approved generic version of Truvada, both to treat and prevent HIV

 

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The U.S. Food and Drug Administration (FDA) just approved the generic version of antiretroviral drug tenofovir disoproxil fumarate/emtricitabine commonly known by brand name Truvada, Gilead Sciences. The approval allows Teva Pharmaceutical to produce first generic version of the drug, which is used as part of treatment plan for HIV as well as pre-exposure prophylaxis (PrEP).

The drug is marketed as fixed dose 200 mg/300 mg combo tablet.

Jeffrey S. Murray, MD, MPH, deputy director of the Division of Anti-Viral Products at the FDA said “Yes, the first generic for Truvada has been approved and will now be available in the U.S. Usually, it takes several generics before full cost-savings potential is reached though. Hopefully, this will help to expand PrEP availability for many.”

The generic version of the drug is already available outside US. It is made in India by Strides Arcolab Limited to be used outside US.

The indication listed in FDA release is “for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk.”

This move by US FDA has huge implications in terms of cost saving. The branded drug which was originally costing someone around $15000 a year, could be reduced to $70 a month, or around $850 a year.

The FDA release can be accessed here.

Here is a video about Truvada, when it was cleared by FDA in 2012.

Vaginal Ring: Could it be a potential option for HIV prevention?

Currently 35million persons are living with HIV-1 infection and about half of them are women. The majority of these live in sub Saharan Africa, which has the highest incidence of HIV infection in any given population.

Using antiretroviral (tenofovir ) as pre exposure prophylaxis ( PrEP) in the form of  pills and vaginal gel  is assuring  approach against fight against  HIV, but patient compliance is very poor and protection was not shown.

Vaginal rings containing exogenous hormones for contraception (Nuvaring ) and HRT are licensed and in use since long and provide a sustained and control release of medication.

The results of two studies were presented at Conference on Retroviruses and Opportunistic Infections (CROI) from February 22 to February 25, 2016,   in Boston, Massachusetts.

One of the study (ASPIRE study) was published today in New England Journal of Medicine and the result of other study( Ring study) was presented as an abstract in the conference.

The trials evaluated the safety and efficacy of a monthly vaginal ring (Ring-004), containing 25 mg of Antiretroviral (ARV) dapivirine, which women placed themselves and replaced each month.

Both the dapivirine and placebo rings were manufactured by QPharma under contract with the International Partnership for Microbicides.

Both studies were double blind randomized placebo controlled trials. The ASPIRE study enrolled 2629 healthy, sexually active, nonpregnant, HIV-1–seronegative women between the ages of 18 and 45 years at 15 research sites in Malawi, South Africa, Uganda, and Zimbabwe women: 1313 in the dapivirine group and 1316 in the placebo group.

In the ring study 1959 women (1762 in South Africa and 197 in Uganda) were randomized in a 2:1 ratio to receive either a dapivirine ring or a placebo ring.

In both studies,the primary efficacy end point was HIV-1 infection, identified with the use of a standard seroconversion algorithm and the primary safety endpoint was incidence of adverse events (AEs).

In both trials the ring was found to be effective in reducing the incidence of HIV-1 infection by 27% (ASPIRE study) and 31% ((Ring study). Both study found that in women less than 21 years of age, the risk of acquiring the infection was not much decreased; probably the women were not compliant enough.

Compliance is also a big issue with the Truvada (Tenofovir disoproxil/emtricitabine), the once a day oral PrEP. Studies have found it to be effective in preventing infection in 92% of cases, but adherence to daily regimen is a problem.

The ring adds a new tool in HIV prevention armament, which could be used discreetly by women, without asking her male partner to use protection. It is especially useful in African countries were women are at highest risk. In the study about 1 in 3 infection were prevented.

The ring is also cost effective, costing only $5 as compared to other PrEP which costs thousands of dollars. Although it is not in the market yet, it gives a lot of hope and optimism for HIV prophylaxis.

Reference:

http://www.avac.org/press-release/first-evidence-vaginal-ring-hiv-prevention

http://www.nejm.org/doi/full/10.1056/NEJMoa1506110#t=articleDiscussion

http://www.healthnewsreview.org/review/vaginal-ring-for-hiv-prevention-small-details-would-have-elevated-good-coverage-to-great/

http://www.croiconference.org/sessions/safety-and-efficacy-dapivirine-vaginal-ring-hiv-1-prevention-african-women