FDA approves Gilead Sciences’ Genvoya HIV drug

Genvoya, a combination tablet approved as a complete regimen, is designed to treat earlier untreated patients weighing about 35 kilograms.

It features elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. Genvoya includes a new form of tenofovir that has not been approved earlier.

The new form of tenofovir offers lower levels of drug in the bloodstream and higher levels within the cells where HIV-1 replicates.

In four clinical trials, Genvoya reduced viral loads when compared to other treatment regimens.

Patients receiving Genvoya had greater increases in serum lipids than those receiving other treatment regimens.

The drug is not approved to treat patients with chronic hepatitis B virus infection. It is not recommended for patients with severe kidney problems.

Gilead Sciences chairman and CEO John Martin said: "While exceptional progress has been made in the field of HIV, there is still a need for new treatment options that may help improve the health of people as they grow older with the disease.

"For more than 25 years, Gilead has been committed to changing the trajectory of HIV management and we are now pleased to introduce Genvoya, the first in a portfolio of TAF-based products that have the potential to advance the long-term treatment of HIV."

The European Medicines Agency Committee for Medicinal Products for Human Use has recently adopted a positive opinion for Genvoya.

Image: Genvoya is designed to treat earlier untreated patients weighing about 35 kilograms. Photo: courtesy of dream designs/FreeDigitalPhotos.net.