Background:
Response to hepatitis B treatment in people with HIV-1/HBV varies by baseline (BL) HBV DNA level and HBeAg status. Here we present a subanalysis of 48W outcomes from a phase 3 study (ALLIANCE) comparing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF) in participants initiating treatment for HIV-1 and HBV to examine HBV DNA suppression and predictors of HBs/eAg loss in this coinfected population.
Methods:
Adults with HIV-1/HBV were randomized 1:1 to initiate blinded treatment with B/F/TAF or DTG+F/TDF (with corresponding placebo). Coprimary endpoints were proportion with HIV-1 RNA < 50 copies/mL (Snapshot) and HBV DNA < 29 IU/mL (missing=failure) at W48: B/F/TAF was noninferior to DTG+F/TDF at achieving HIV-1 RNA < 50 copies/mL and superior at achieving HBV DNA < 29 IU/mL (Avihingsanon et al., AIDS 2022). Subgroup analyses determined the proportion with HBV DNA < 29 IU/mL stratified by BL HBV DNA < or ≥ 8 log10 IU/mL and HBeAg status (-/+ at BL). A multivariate analysis (MVA) was conducted to evaluate predictors of HBV DNA < 29 IU/mL and HBs/eAg loss.
Results:
243 participants were randomized/treated (121 B/F/TAF, 122 DTG+F/TDF) from 46 sites globally. HBV DNA < 29 IU/mL was achieved by 53% (63% B/F/TAF, 43% DTG+F/TDF), HBsAg loss by 9% (13% B/F/TAF, 6% DTG+F/TDF) and HBeAg loss by 20% (26% B/F/TAF, 14% DTG+F/TDF). Among those with BL HBV DNA < 8 log10 IU/mL (116/241), B/F/TAF-treated participants achieved significantly higher rates of HBV DNA < 29 IU/mL compared to DTG+F/TDF (87% vs 68%, p=0.008); for those with HBV DNA ≥8 log10 IU/mL at BL (125/241), B/F/TAF was also numerically higher (39% vs 23%, p=0.073). Among those who were HBeAg+ at BL (187/241), B/F/TAF-treated participants achieved significantly higher rates of HBV DNA < 29 IU/mL compared to DTG+F/TDF (51% vs 31%, p=0.0065); in those who were HBeAg- (54/241), response was also numerically higher (100% vs 92%, p=0.055). Baseline predictors of HBV DNA < 29 IU/mL from a MVA were: HBeAg-, HBV DNA < 8 log10 IU/mL, ALT >ULN and treatment with B/F/TAF; BL predictors of HBs/eAg loss included BL ALT >ULN and BL CD4 ≥200 cells/µL (Table 1).
Conclusions:
In adults with HIV-1/HBV coinfection initiating therapy, B/F/TAF resulted in superior HBV DNA suppression compared to DTG+F/TDF. In MVA, B/F/TAF treatment was an independent predictor of HBV DNA suppression.
Multivariate Logistic Regression Analysis