Bulevirtide safe, effective in HDV-induced cirrhosis with hypertension

A recent study has demonstrated the safety and efficacy of bulevirtide (BLV) monotherapy for 48 weeks in difficult-to-treat patients with hepatitis delta virus (HDV)-related compensated cirrhosis and clinically significant portal hypertension (CSPH).

A team of investigators conducted a single-centre study, including 18 consecutive patients with HDV-related compensated cirrhosis and CSPH who initiated BLV 2 mg/day. They collected clinical and virological characteristics at baseline, weeks 4, 8, and every 8 weeks thereafter. HDV RNA was quantified using Robogene 2.0 (lower limit of detection 6 IU/ml).

The participants had a mean age of 48 years, and 67 percent were male. Their median platelet count was 70x10³/μl, liver stiffness measurement (LSM) 16.4 kPa, alanine aminotransferase (ALT) 106 U/L, HBsAg 3.7 log IU/ml, and HDV RNA 4.9 log IU/ml.

Over 48 weeks, HDV RNA decreased by 3.1 log IU/ml (p<0.001 vs baseline), becoming undetectable in five patients (23 percent). Fourteen patients (78 percent) also achieved a virological response, while two (11 percent) did not respond to treatment.

ALT decreased to 35 U/L (p<0.001 vs baseline), which normalized in 83 percent of patients. Sixty-seven percent of patients also showed a combined response. Likewise, levels of aspartate aminotransferase and gamma-glutamyltransferase significantly improved.

For liver function parameters, albumin values increased while bilirubin remained stable. LSM markedly improved in patients with virological response, but platelet count remained unchanged.

Fortunately, decompensating events and hepatocellular carcinoma did not develop in patients. In addition, BLV was well tolerated. None of the participants ceased treatment, while the increase in bile acids was asymptomatic.

“HDV is associated with the most severe form of viral hepatitis,” the investigators said. “A new treatment for HDV called bulevirtide has recently received conditional approval for patients with chronic HDV infection.”