Gilead nabs HIV drug OK, rivals sue

Feb 09, 2018

The U.S. FDA has approved Gilead’s new HIV drug, Biktarvy, a once-daily, triple-combination tablet.

Biktarvy combines new integrase inhibitor bictegravir with Descovy, an older medication that combines emtricitabine and tenofovir alafenamide.

According to Gilead, Biktarvy does not require testing for HLA-B*5701 (a gene that predisposes patients to having an allergic reaction from HIV med, abacavir), has no food intake requirements, and has no baseline viral load or CD4 count restrictions. The drug’s label includes a boxed warning that use could worsen hepatitis B infection in certain patients.

Rival ViiV Healthcare, a joint venture majority-owned by GSK, with Pfizer and Shionogi Limited as shareholders, immediately filed a lawsuit alleging that Gilead was infringing patents related to the ViiV’s triple-drug HIV treatment, Triumeq. Specifically, Viiv says Biktarvy infringes on its patent covering dolutegravir and other compounds that include dolutegravir’s unique chemical scaffold.

The global market for HIV drugs could reach as high as $40 billion a year by 2021, according to Quintiles IMS Institute.

Read the Gilead press release