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UNITY-2: Patients with HCV, cirrhosis achieve SVR12 on fixed-dose regimen

Treatment-naive and experienced patients with chronic hepatitis C virus genotype 1 infection and cirrhosis achieved a sustained virologic response at 12 weeks while on a fixed-dose regimen of daclatasvir, asunaprevir and beclabuvir, according to newly published data in JAMA.

In the UNITY-2 trial, researchers, including Andrew J. Muir, MD, of the Duke Clinical Research Institute at the Duke University School of Medicine in North Carolina, randomly assigned 112 treatment-naive patients and 90 treatment-experienced patients to receive a twice daily, fixed-dose combination of 30 mg of daclatasvir (Bristol-Myers Squibb), 200 mg of asunaprevir (Bristol-Myers Squibb) and 75 mg of beclabuvir (BMS-791325, Bristol-Myers Squibb) with or without ribavirin for 12 weeks.

Andrew J. Muir

Overall, a sustained virologic response at 12 weeks (SVR12) was achieved by 98% of patients in the treatment-naive group and 93% in the treatment-experienced group when ribavirin was included in the regimen. The fixed-dose combination without ribavirin yielded a 93% SVR12 response rate in treatment-naive patients and 87% response rate in the treatment-experienced patients.

Two patients in the treatment-experienced group experienced virologic breakthrough and one patient in the treatment-experienced group had detectable HCV RNA at the end of 12 weeks. No virologic breakthroughs were observed in the treatment-naive group.

Of the patients, 199/202 completed therapy; three patients, all in the treatment-experienced group, discontinued treatment before 12 weeks.

Nine patients experienced serious adverse events, of which three were considered treatment-related; anemia, alanine aminotransferase and bilirubin elevations and ribavirin overdose. Four patients discontinued use of ribavirin due to anemia, hemoglobin reduction, cough or other complications. However, all four of these patients subsequently achieved SVR12, according to the research.

“The regimen was well-tolerated with or without ribavirin, with low rates of treatment-related serious adverse events, adverse-related discontinuations or grade 3 or 4 laboratory abnormalities,” the researchers wrote. – by Melinda Stevens

Disclosure: Muir reports receiving grant funds from BMS while conducting the study; grant funding and personal fees from AbbVie, Achillion, BMS, Gilead and Merck; personal fees from Theravance; and grant funding from Roche outside of this study. Please see the full study for a list of all other authors’ relevant financial disclosures.