Gilead's HIV Triple Combo Gets Sped-up FDA Review, Decision Date Locked Down

Published: Aug 11, 2017

Gilead's HIV Triple Combo Gets Sped-up FDA Review, Decision Date Locked Down August 11, 2017
By Alex Keown, BioSpace.com Breaking News Staff

FOSTER CITY, Calif. – HIV drug watchers and Gilead Sciences investors have marked Feb. 12, 2018 on their calendars. That’s the day the U.S. Food and Drug Administration is expected to review the company’s HIV treatment that some analysts suggest could become a blockbuster.

The FDA granted Gilead’s New Drug Application for its combination treatment of bictegravir and emtricitabine/tenofovir alafenamide a priority review. The drug cocktail is designed for the treatment of HIV-1. Gilead filed its NDA with the priority review voucher on June 12. Bictegravir in combination with FTC/TAF as a single tablet regimen.

Gilead, which has been the market leader in hepatitis C treatments, also has a strong HIV pipeline. The NDA for the combination dose was supported by Phase III data that demonstrated high rates of suppression of the virus. When the NDA was announced in June, Norbert Bischofberger, Gilead’s chief scientific officer, said the company has a goal of simplifying the management of HIV for a wide set of patients with the combination treatment. Gilead’s HIV cocktail combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the FTC/TAF backbone, Bischofberger said at the time.

Phase III data from four separate studies, which were released in May, showed the drug met primary endpoints of non-inferiority. The combination treatment was designed to explore the efficacy and safety of BIC/FTC/TAF compared to regimens containing dolutegravir (50mg) (DTG) among treatment-naïve patients (Studies 1489 and 1490), and among virologically suppressed patients switching from an existing antiretroviral regimen.

"Since the approval of Viread 16 years ago, Gilead has continually worked to develop and improve treatments for people living with HIV. This investigational single tablet regimen brings together the potency of an integrase inhibitor, bictegravir, with the demonstrated efficacy and safety profile of the FTC/TAF backbone,” Bischofberger said in May.

In addition to seeking approval from the FDA, Gilead Sciences is also seeking approval for the BIC/FTC/TAF treatment from the European Medicines Agency.

Earlier this month the FDA approved expanded labelling of Gilead’s drug Epclusa. That drug was the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV. HCV co-infection remains a major cause of morbidity in HIV-infected individuals.

Gilead’s use of its priority review voucher will keep rival GlaxoSmithKline in sight. In May, GSK and subsidiary ViiV Healthcare submitted a priority review voucher to both the FDA and EMA for its HIV combination treatment of dolutegravir (Tivicay) and rilpivirine (Edurant). The drug is intended to be used for the maintenance treatment of HIV-1 infection. GSK quietly paid $130 million for the voucher as part of its effort to beat Gilead Sciences to the market.

Not to be outdone in the HIV market, in July Merck announced it intended to file a NDA for its drug doravirine. The Merck drug does not have food restrictions, which that company believes is a key benefit to patients. George Hanna, head of clinical research at Merck Research Laboratories , told BioSpace that trial data at 48 weeks shows doravirine, a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI), is slightly more effective than the commonly used drug Atripla, which is a triple cocktail of efavirenz (EFV), emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) in treatment-naïve adults infected with HIV-1.

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