Positive Clinical Trial Results Allow FDA To Approve New HIV Treatment

Single Pill Combination Drug to Treat HIV Type-1

Gilead Sciences announced early this March that the U.S. Food and Drug Administration has approved Odefsey for treating HIV-1 infections. Odefsey, a single tablet, is a combination drug made up of emtricitabine, rilpivirine, and tenofovir aladfenamide (TAF). It has been approved to treat HIV type-1, the most common form of HIV.

In November of last year, Genvoya, another Gilead drug treating HIV, was the first drug containing TAF to receive FDA approval. Odefsey, now the second FDA-approved TAF drug, is now the smallest single tablet regimen HIV treatment on the market.

How the TAF HIV Treatment Works

TAF presents a high antiviral efficacy similar to and requiring less than 1/10th than that of Viread, Gilead’s HIV TDF treatment. TAF data has shown that it can enter cells, namely HIV-infected cells, at a more effect rate than TDF, therefore requiring a lower dose. TAF has shown to also have fewer side effects than TDF.

“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.”

Following the approval of Genvoya, and now Odefsey, Gilead Sciences is working on obtaining FDA approval for the HIV-1 drug Descovy (emtricitabine+TAF), which had been EMA-recommended for EU approval a week prior to Odefsey.

Odefsey Requirements for Potential HIV Patients

Gilead Sciences has taken into consideration that the younger an HIV patient is, the higher risk they are for the development of age- and treatment-related diseases, for the early combination of HIV infection, antiretroviral treatments and the natural aging process weakens bone mineral density and causes renal impairment. Odefsey is a complete regimen for patients starting at the age of 12 years who have not yet received antiretroviral treatment and have HIV-1 RNA levels less than or equal to 100,00 copies per mL.

Odefsey can also serve as a replacement for a stable antiretroviral regimen in patients with HIV-1 RNA less than 50 copies per mL (virologically-suppressed) for at least 6 months, with the same requirement of not having had a history of failed treatments.

Enroll As a Patient in to Help Advance Clinical Research Trials

The FDA-approved HIV drug Odefsey brings about another success for Gilead Sciences’ TAF-based infections. While neither Odefsey, nor does any currently marketed drug, cure HIV infection or AIDS, this new drug regimen allows for a longer term of managing HIV treatments. Such advancements in clinical research are only made possible by the combination of both researchers’ and patients’ efforts. FDA approval is only gained after the drug has been tested in clinical research trials. Therefore, if you would like to help make a difference in research trials just like this, sign up and enroll as a patient.  We thank you for your participation to make a difference.