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UNITY-1: Fixed-dose Combo Yields High SVR12 in HCV Patients Without Cirrhosis

Treatment-naive and experienced patients with chronic hepatitis C virus genotype 1 infection without 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.

Fred Poordad, MD, of the Texas Liver Institute and University of Texas Health Science Center in San Antonio, and colleagues, randomly assigned 312 treatment-naive patients and 103 treatment-experienced patients with HCV genotype 1 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) for 12 weeks.

Overall, a sustained virologic response at 12 weeks (SVR12) was achieved by 92% (287/312) of patients in the treatment-naive group and 89.3% (92/103) in the treatment-experienced group.

Eight-percent of all patients experienced virologic failure (34/415).

At least 10% of patients experienced an adverse event, with the most common being headache, fatigue, diarrhea and nausea, according to the research. Seven serious adverse events were observed among the patients. However, all were considered unrelated to the treatment regimen and less than 1% of these events led to treatment discontinuation.

“The SVR12 rates observed in this study are comparable with results observed with other phase 3 studies of all-oral, DAA-only regimens in patients with HCV genotype 1 infection,” the researchers wrote.

In an editorial, Hari Conjeevaram, MD, MSc, professor of internal medicine at University of Michigan Medical School in Ann Arbor, stated that this study by Poordad and colleagues is one of the studies that has “revolutionized management of hepatitis C.”

“[This study] adds to the armamentarium of all-oral interferon- free regimens that have revolutionized management of hepatitis C, not only for patients who are treatment-naive with no significant liver disease, but also for those who are treatment-experienced and those with cirrhosis.”

Despite the successes in HCV therapy, Conjeevaram also stated there is more work to be done.

“Despite the progress and success of viral eradication, numerous questions remain unanswered such as response based on race, still difficult-to-treat situations such as patients with end-stage liver disease or undergoing hemodialysis, access to and affordability of these therapies, improvement in quality of life and cost-effectiveness.”  – by Melinda Stevens

Disclosure: Conjeevaram reports no relevant financial disclosures. Poordad reports receiving grants and personal fees from BMS, Gilead, AbbVie, Janssen, Merck, Novartis and Salix, as well as grants from Idenix, Theravance and Achillion. Please see the study for a list of all other authors’ relevant financial disclosures.