Treatment With Bulevirtide in HIV Infected patients With chronic Hepatitis Delta. ANRS HD EP01 BULEDELTA & Compassionate Cohort

Background and Aims In France, Bulevirtide (BLV) was available in September 2019 through an early access program to treat patients with hepatitis Delta virus (HDV). The aim of this analysis was to evaluate the efficacy and safety of BLV in HIV patients with HDV coinfection. Patients and methods Patients received BLV 2 mg +/- pegylated interferon (pegIFNα) according to the physician’s decision. The primary endpoint (per-protocol analysis) was the virological response rate at week 48, defined as the proportion of patients with undetectable serum HDV-RNA or HDV-RNA decline > 2 log10 IU/mL from baseline. Results Characteristics of the 38 patients were as follow: 28 male, mean age 47.7 years, mean baseline HDV-RNA viral load 5.7 ± 1.2 log10 IU/ml. Median HIV viral load and mean CD4 count were 32 (30 - 65) cp/ml and 566 ± 307/mm3, respectively. Eight patients stopped treatment before week 48. At W48, 10 of 19 patients (52.6%) in the 2 mg BLV group, and 5 of 7 patients (71.4%) in the 2 mg BLV + pegIFNα group had reached virological response (no HDV-RNA available in 4 patients). At W48, 7/19 patients in the 2 mg BLV group, and 3/6 patients in the 2 mg BLV + pegIFNα group had combined response (virological response and normal ALT level). Conclusion Adults living with HIV coinfected with HDV can be treated by BLV with a virological response in more than 50% of patients. The combination of BLV and pegIFNα showed a strong virological response. IMPACT AND IMPLICATIONS • Bulevirtide is the only EMA-approved drug for HDV treatment and we showed that it can be used in adults living with HIV, with an overall good tolerability.• Bulevirtide induces a virologic response in more than 50% of patients suggesting that Bulevirtide should be considered as a first-line therapy in this specific population.• Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contra-indication.• No specific drug-drug interaction is reported.