Bulevirtide Appears Effective for HDV-Related Compensated Cirrhosis and CSPH

Bulevirtide 2mg daily led to remarkable improvement in treating patients with hepatitis D (HDV) with compensated cirrhosis and clinically significant portal hypertension (CSPH), a new study indicates. The findings of the study are published in Journal of Hepatology.

“This is the first study evaluating effectiveness and safety of Bulevirtide [BLV] 2 mg/day monotherapy for 48 weeks in patients with HDV-related compensated cirrhosis and CSPH,” the researchers noted.

The investigators analyzed data from patients with HDV who suffered from compensated cirrhosis and CSPH and were being treated bulevirtide monotherapy. Clinical and virological characteristics were collected at week 4, week 8, and then every 8 weeks thereafter throughout the 48-week course for this single-center study.

Of the 18 patients enrolled in the study (all White), all patients presented a gradual decline in HDV RNA levels by 3.1 log IU/mL (p<0.001 vs. baseline). In 5 patients, the HDV RNA levels were undetectable by the end of 48-week evaluation period; 14 patients reported a positive virological response and 2 patients reported a nonresponse. Alanine aminotransferase decreased to 35 U/L, normalizing in 83% of the patients, while 67% of the patients reported a combined response.

In general, the aspartate aminotransferase and gamma-glutamyl transferase levels positively improved, albumin values and liver function parameters significantly increased, and bilirubin remained stable. “LSM significantly improved in patients with virological response, while platelet count was unchanged. None of the patient developed decompensating events or hepatocellular carcinoma,” the authors elaborated. They added that bulevirtide was well tolerated, none of the patients opted out of the treatment, and increased levels of bile acids were fully asymptomatic.

“A 48-week course of BLV 2 mg/day monotherapy is safe and effective even for difficult-to treat HDV patients with compensated cirrhosis and CSPH,” the authors concluded.

—Priyam Vora

Reference:

Degasperi E, Anolli M, Renteria S et al. Bulevirtide monotherapy for 48 Weeks in hdv patients with compensated cirrhosis and clinically significant portal hypertension. J Hepatol. Published Online: August 13, 2022. DOI: https://doi.org/10.1016/j.jhep.2022.07.016