Randomized trial compares virological failure rates of dual and triple therapies in HIV patients with past HBV infection, suggesting no increased risk from dual therapy.
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.
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Borghetti et al. (2026) studied this question.
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