Phase 3b switch study to B/F/TAF FDC in HIV subjects aged >= 65 years
Research type
Research Study
Full title
A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching from an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years
IRAS ID
238122
Contact name
Laura Waters
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2017-003428-61
Duration of Study in the UK
1 years, 2 months, 15 days
Research summary
Despite marked improvements in HIV treatments, there remains a need for new therapies. Challenges including lifelong adherence and the ageing of HIV-positive populations require treatments that are well-tolerated, simple to take and with less effect on age-related conditions like kidney, heart and bone disease. HIV guidelines recommend 3-drug combinations for most patients. Bictegravir is an HIV inhibitor which is co-formulated with emtricitabine (F) and tenofovir alafenamide (TAF) into a single fixed dose combination (FDC) tablet for once-daily use (B/F/TAF).
This study, sponsored by Gilead Sciences, Inc, aims to test the effectiveness of switching to B/F/TAF in people aged 65 years or over who already have suppressed virus (where the virus is undetectable in blood using standard tests) on either:
• Genvoya: a FDC single tablet containing elvitegravir/cobicistat/F/TAF (E/C/F/TAF) or
• A triple combination containing tenofovir disoproxil fumarate (TDF) with two other drugs
Possible advantages of B/F/TAF over E/C/F/TAF include:
1. Fewer interactions with other medications (cobicistat is a ‘booster’ which blocks breakdown of some HIV medications in the liver; consequently, it interferes with breakdown of other drugs (e.g. cholesterol-lowering drugs)
2. No requirement to take with food
Possible advantages of B/F/TAF over TDF-containing combinations include:
1. TAF has less effect on kidney and bone tests than TDF which may be particularly important in older people with HIV
2. Depending on the other drugs combined with TDF there may be fewer pills, no food restrictions and fewer drug interactions
Approximately 80 participants will take part in this study at 31 sites in 5 European countries. Participation will last about one year with a requirement to visit the clinic at least 6 times.
Participants will switch from E/C/F/TAF FDC or TDF-containing treatment to B/F/TAF.
B/F/TAF tolerability will be determined by physical exams, laboratory tests, questionnaires, and monitoring any symptoms or problems during the study.REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/0112
Date of REC Opinion
6 Apr 2018
REC opinion
Further Information Favourable Opinion