Real-world effectiveness and safety of bulevirtide monotherapy for up to 96 weeks in patients with HDV-related cirrhosis.
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Degasperi Elisabetta, Anolli Maria Paola, Jachs Mathias, Reiberger Thomas, De Ledinghen Victor, Metivier Sophie, D'Offizi Gianpiero, di Maria Francesco, Schramm Christoph, Schmidt Hartmut, Zöllner Caroline, Tacke Frank, Dietz-Fricke Christopher, Wedemeyer Heiner, Papatheodoridi Margarita, Papatheodoridis George, Carey Ivana, Agarwal Kosh, Van Bömmel Florian, Brunetto Maurizia R, Cardoso Mariana, Verucchi Gabriella, Ciancio Alessia, Zoulim Fabien, Aleman Soo, Semmo Nasser, Mangia Alessandra, Hilleret Marie-Noelle, Merle Uta, Santantonio Teresa A, Coppola Nicola, Pellicelli Adriano, Roche Bruno, Causse Xavier, D'Alteroche Louis, Dumortier Jérome, Ganne Nathalie, Heluwaert Frederic, Ollivier Isabelle, Roulot Dominique, Viganò Mauro, Loglio Alessandro, Federico Alessandro, Pileri Francesca, Maracci Monia, Tonnini Matteo, Arpurt Jean-Pierre, Barange Karl, Billaud Eric, Pol Stanislas, Gervais Anne, Minello Anne, Rosa Isabelle, Puoti Massimo, Lampertico Pietro
Аннотация
METHODS: Consecutive HDV-infected patients with cirrhosis starting BLV 2 mg/day from September 2019 were included in a European retrospective multicenter real-world study (SAVE-D). Patient characteristics before and during BLV treatment were collected. Virological, biochemical, combined responses, adverse events and liver-related events (hepatocellular carcinoma [HCC], decompensation, liver transplant) were assessed.
RESULTS: A total of 244 patients with HDV-related cirrhosis receiving BLV monotherapy for a median of 92 (IQR 71-96) weeks were included: at BLV start, median (IQR) age was 49 (40-58) years and 61% were men; median ALT, LSM and platelet count were 80 (55-130) U/L, 18.3 (13.0-26.3) kPa, and 94 (67-145) x103/mm3, respectively; 54% had esophageal varices, 95% Child-Pugh A cirrhosis, and 10% HIV coinfection; 92% were on nucleos(t)ide analogues; median HDV RNA and HBsAg were 5.4 (4.1-6.5) log10 IU/ml and 3.8 (3.4-4.1) log10 IU/ml, respectively. At weeks 48 and 96, virological, biochemical and combined responses were observed in 65% and 79%, 61% and 64%, 44% and 54% of patients, respectively. AST, GGT, albumin, IgG and LSM values significantly improved throughout treatment. Serum bile acid levels increased in most patients, but only 10% reported mild and transient pruritus, which was independent of bile acid levels. The week 96 cumulative risks of de novo HCC and decompensation were 3.0% (95% CI 2-6%) and 2.8% (95% CI 1-5%), respectively. Thirteen (5%) patients underwent liver transplantation (n = 11 for HCC, n = 2 for decompensation).
CONCLUSION: BLV 2 mg/day monotherapy for up to 96 weeks was safe and effective in patients with HDV-related cirrhosis. Virological and clinical responses increased over time, while the incidence of liver-related complications was low.
IMPACT AND IMPLICATIONS: Bulevirtide 2 mg/day is EMA approved for the treatment of compensated chronic hepatitis delta; however, real-world data in large cohorts of patients with cirrhosis are lacking. Bulevirtide 2 mg/day monotherapy for up to 96 weeks was safe and effective (week 96: 79% virological, 64% biochemical and 54% combined response) in a large real-world cohort of patients with HDV-related cirrhosis, including patients with clinically significant portal hypertension. Liver function tests and liver stiffness improved, suggesting a potential clinical benefit in patients with advanced liver disease, while the incidence of de novo liver-related events (hepatocellular carcinoma and decompensation) was low during the 96-week study period.