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Efficacy of dolutegravir/lamivudine (DTG/3TC) in adults with HIV-1 and isolated reactive hepatitis B core antibody (anti-HBc): results from the phase 3/3b GEMINI-1/-2, STAT, TANGO, and SALSA
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D. Fox*1,, J. Slim22,, 32,, E.T. Overton1,, A. Doblado-Maldonado3,, P. Jeffery4,, R.A. Grove4,, C.M. Parry5,, M. Underwood1,, B. Jones5,.
Abstract
BACKGROUND: As 2-drug antiretroviral therapy regimens emerge, clinical management of people living with HIV-1 and isolated reactive anti-HBc is important. In real-world studies of people living with HIV-1 switching to 2-drug regimens, reactive anti-HBc was associated with lower HIV-1 suppression rates but not elevated liver enzymes or hepatitis B virus (HBV) reactivation. However, further evaluation is warranted. We present outcomes for participants with isolated reactive anti-HBc receiving DTG/3TC vs comparator regimens in phase 3/3b studies.
METHODS: This analysis includes individuals with past HBV exposure (reactive anti-HBc), no evidence of active HBV infection, and non-reactive HBV surface antibody among treatment-naive participants in GEMINI-1/-2 and STAT and virologically suppressed participants in TANGO and SALSA.
RESULTS:
Overall, 46 participants in GEMINI-1/-2, 5 in STAT, 13 in TANGO, and 12 in SALSA had isolated reactive anti-HBc. Proportions of participants with HIV-1 RNA <50 c/mL or HIV-1 RNA <40 c/mL and target not detected were generally high and comparable between treatment groups across all studies; few participants experienced HIV-1 RNA =50 c/mL (Figure). Liver function test toxicities were reported in 10/23 (43%) participants receiving DTG + 3TC in GEMINI-1/-2 and 3/16 (19%) receiving DTG/3TC in TANGO/SALSA; most were grade 1 or 2. Across studies, 1 participant receiving DTG + 3TC in GEMINI-1/-2 had hepatitis E virus infection and liver enzyme elevations that met liver-stopping criteria, which led to treatment discontinuation at ~144 weeks and study withdrawal. Adverse events typically associated with HBV were reported in 5/23 (22%) participants receiving DTG + 3TC in GEMINI-1/-2 and 1/9 (11%) receiving DTG/3TC in TANGO. No HBV reactivation was reported in any study.
CONCLUSIONS: Among people living with HIV-1 with isolated reactive anti-HBc, DTG/3TC demonstrated high and similar HIV-1 suppression rates vs 3-/4-drug comparator regimens, with few liver enzyme elevations leading to discontinuation and no reports of HBV reactivation.
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