New HIV Treatment Combo Shows Better Response Rate Than bPIs
Coformulated bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is noninferior to boosted protease inhibitor regimens (bPIs) among individuals with human immunodeficiency virus (HIV), according to a recent study. Individuals who switched from bPIs to B/F/TAF had shown high rates of virologic suppression without drug resistance.
Findings from the study were presented at ID Week, which took place from October 4 to 8, 2017, in San Diego, California.
Shingles More Common in HIV Patients
Patients With HIV May Not Receive Enough Screening for Comorbidities
bPIs are effective and are commonly used in individuals with HIV who have low rates of adherence. However, bPIs can interact with other drugs and can cause gastrointestinal adverse effects. In previous randomized studies, B/F/TAF has shown high efficacy and tolerability among treatment-naïve adults.
For their study, the researchers evaluated 577 adults with HIV who were suppressed on regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF). Median patient age was 48 years, and 17% were women. A total of 85% of patients had been receiving a bPI with FTC/TDF at screening.
Patients were randomly assigned to either continue their current bPI regimen (n = 287) or switch to once-daily, open-label, coformulated 50 mg B/200 mg F/25 mg TAF (n = 290).
The primary outcome was the proportion of patients with HIV-1 ribonucleic acid (RNA) of 50 c/mL at week 48, based on a US Food and Drug Administration (FDA) snapshot. Secondary outcomes included the proportion of patients with HIV-1 RNA below 50 c/mL and safety measures at week 48.
Results indicated that switching to B/F/TAF is noninferior to continuing treatment with bPIs. A total of 1.7% of patients in each group had HIV-1 RNA of 50 c/mL or more. However, 92.1% of patients on B/F/TAF had HIV-1 RNA below 50 c/mL, compared with 88.9% of patients on bPIs.
No patients on B/F/TAF had developed resistance to the study drugs. Grade 3 or 4 adverse events had occurred in 4% of patients on B/F/TAF, and 6% of patients on bPI. The researchers observed no renal discontinuations or tubulopathy cases in patients on B/F/TAF.
“Adults switching to B/F/TAF from a boosted PI maintained high rates of virologic suppression without resistance,” the researchers concluded. “B/F/TAF was safe and well tolerated.”
Daar E, DeJesus E, Ruane P, et al. Phase 3 randomized, controlled trial of switching to fixed-dose bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) from boosted protease inhibitor-based regimens in virologically suppressed adults: week 48 results. Open Forum Infect Dis. 2017;4(Suppl_1):S735. https://doi.org/10.1093/ofid/ofx180.003.