Efficacy of dolutegravir/lamivudine in adults with <scp>HIV</scp> ‐1 and isolated reactive hepatitis B core antibody: Insights from Phase 3/3b study results

OBJECTIVES: As two-drug HIV-1 antiretroviral therapy (ART) regimens become standard, data gaps remain concerning their safety and efficacy among people with isolated reactive hepatitis B core antibodies (anti-HBc). Here, we assessed the safety and efficacy of dolutegravir/lamivudine (DTG/3TC) versus three- or four-drug regimens (3DRs/4DRs) among people with HIV-1 and isolated reactive anti-HBc. METHODS: Data were evaluated from GEMINI-1, GEMINI-2, STAT, TANGO and SALSA at various time points, including Weeks 48, 96, 144 and 196. Participants had hepatitis B virus (HBV) exposure, isolated reactive anti-HBc serology, no HBV infection and were naive to ART (GEMINI-1/-2, STAT) or virologically suppressed before switching (TANGO, SALSA). All studies except STAT had a 3DR/4DR comparator. RESULTS: Of 2798 participants, 76 (DTG/3TC, n = 44; 3DR/4DR, n = 32) had isolated reactive anti-HBc. Across studies, no instances of HBV reactivation occurred, and liver chemistry elevations were infrequent and generally mild. Among those naive to ART at baseline and receiving DTG/3TC, 78% (18/23) achieved HIV-1 RNA <50 copies/mL at Week 144 in GEMINI-1/-2, and 60% (3/5) achieved HIV-1 RNA <50 copies/mL at Week 48 in STAT. Among participants with virologic suppression at baseline who switched from 3DR/4DR to DTG/3TC, none experienced HIV-1 RNA ≥50 copies/mL at the end of TANGO (Week 196) or SALSA (Week 48). HIV-1 suppression rates were comparable to those of 3DRs/4DRs. CONCLUSIONS: This analysis provides new information about DTG/3TC treatment for people with HIV-1 and isolated reactive anti-HBc. There were high rates of HIV-1 suppression with DTG/3TC, no cases of HBV reactivation and no new safety signals identified.