FDA approves Biktarvy to treat HIV infection.- Gilead Sciences

Gilead Sciences, Inc. announced that the FDA has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available.

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. No dosage adjustment of Biktarvy is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute. Biktarvy does not require testing for HLA-B*5701, has no food intake requirements, and has no baseline viral load or CD4 count restrictions. According to Biktarvy’s Prescribing Information, prior to or when initiating treatment with Biktarvy, healthcare providers should test for hepatitis B virus (HBV) infection and renal function, and monitor renal function as clinically appropriate during therapy.

Comment: -ViiV Healthcare, has announced that it has filed patent infringement litigation against Gilead Sciences Inc. over bictegravir in the United States and Canada. The United States case is filed in the U.S. District Court for the District of Delaware and the patent is U.S patent No. 8,129,385. The Canadian case is filed in the Canadian Federal Court in Toronto and the patent is Canadian Patent No. 2,606,282. ViiV Healthcare will seek to prove that Gilead Sciences Inc’s triple combination HIV drug containing the HIV integrase inhibitor bictegravir infringes ViiV Healthcare’s patent covering ViiV Healthcare’s dolutegravir and many other compounds that include dolutegravir’s unique chemical scaffold.