Risk of Virological Failure After Switch to a Tenofovir-Sparing Dual Therapy in Virologically Suppressed People With...

We compared the effectiveness of tenofovir (TFV)-based triple regimens (TT) to TFV-sparing dual therapies (DT) in virologically suppressed, HBsAg-/HBcAb+ people living with HIV (PLWH). We emulated a target trial including adults PLWH from five University Hospitals, with HBsAg-/HBcAb+ serostatus, starting a TT with unsuppressed serum HIV-RNA and reaching HIV-RNA < 50 cp/mL (baseline). PLWH starting a DT (3TC + bPI or DTG, DTG + RPV, DOR + DTG or long-acting CAB + RPV) were considered in the "treatment"-group only if they switched within a 1-year grace period; all other PLWH were considered "control"-group. To emulate randomization, participants were cloned at baseline and assigned the opposite strategy, then censored at the time of strategy-deviation and assigned a weight based on the inverse-probability of being uncensored. Probabilities of 5-year virological failure (VF; two consecutive HIV-RNA > 50 cp/mL or a single HIV-RNA ≥ 200 cp/mL) were estimated through a weighted Kaplan-Meier estimator. Overall, 415 PLWH were eligible for study analysis: 71 (17.1%) started a DT (3TC-based: 78.9%) during follow-up. They were mainly men (329, 79.3%), with a median age of 48 years. In the weighted analysis, the estimated probabilities of VF were: 29.3% for DT and 29.9% for TT at 5 years (difference: 0.5%; 95% CI: -28.7, +21.6). A higher VF risk was seen in the subset of PLWH with undetectable HBsAb at the longest follow-up available (4 years), independently of treatment group: 15.5% and 36.8% with DT and TT, respectively (difference: -21.3%; 95% CI: -30.3, -13.8). Switch to a TFV-sparing DT, compared with continuing a TT, was not associated with an increased risk of VF in PLWH and prior HBV infection.