Bictegravir Approved for Initial ART, in Combination with TAF/FTC
April 11, 2018
Bictegravir (BIC), a new integrase inhibitor, was recently approved by the FDA for use in a single-pill coformulation with TAF/FTC (brand name: Biktarvy) as initial therapy and as a switch regimen for patients who are already on a suppressive ART regimen and who have no history of treatment failure and no known resistance to the BIC/TAF/FTC components. BIC/TAF/FTC is taken once daily, and there are no food requirements.
FDA approval was based on the results of four Phase III studies of this combination, two in initial therapy and two in switch studies. In these, BIC/TAF/FTC proved to be generally comparable with dolutegravir plus either TAF/FTC or ABC/3TC in both efficacy and adverse effects (though it resulted in lower rates of nausea compared with DTG/ABC/3TC). No emergent integrase resistance was seen in BIC recipients.
On March 27, 2018, the combination of BIC/TAF/FTC was added the to the DHHS's list of Recommended Initial Regimens for Adults with HIV.
Clinical Bottom Line
BIC/TAF/FTC is a welcome single-pill option for initial therapy, one that appears to be equivalent in efficacy to dolutegravir + 2 NRTIs and that contains neither abacavir nor a PK booster (as a bonus, the tablet is quite small). It is important to note that BIC/TAF/FTC has not been studied in treatment-experienced persons or those whose HIV has mutations that confer resistance to ARVs. Many potential interactions with other drugs have not been studied thoroughly. It is known that BIC cannot be used with rifampin or rifabutin and, like other integrase inhibitors, may require special timing when given with polyvalent cations such as aluminum, calcium, iron, and magnesium. BIC/TAF/FTC has not been studied in combination with other ARVs, and the Biktarvy prescribing information recommends against its use with other ARVs.
Susa Coffey is medical editor of the NCRC. She is a Professor of Medicine at UCSF in the Division of HIV, Infectious Diseases and Global Medicine and a longtime clinician and educator in the HIV at San Francisco General Hospital clinic (“Ward 86”). She also is medical editor of HIV InSite. Dr. Coffey is Co-Lead of the RAPID clinical program at Ward 86, San Francisco General Hospital and the Chair of the RAPID Committee of San Francisco's Getting to Zero campaign.