Ravidasvir plus ritonavir-boosted danoprevir with ribavirin for 12 weeks resulted in 100% sustained virologic response among a cohort of Asian patients with hepatitis C genotype 1 without cirrhosis, according to recently published results of a phase 2 study.
“Many patients are intolerant or ineligible for interferon-based therapies. The efficacy of interferon-based therapies can be affected by factors such as cirrhosis status, HCV genotype (GT), IL28B genotype, etc.,” Jia-Horng Kao, MD, from the National Taiwan University College of Medicine and Hospital, and colleagues wrote. “All-oral, interferon-free regimens of direct-acting antivirals (DAAs) are better tolerated than interferon-based regimens with improved sustained virologic response (SVR) rates and shorter treatment duration.”
The researchers enrolled 37 patients with HCV genotype 1b and one patient with genotype 1a from five centers in Taiwan between December 2015 and March 2016. Patients received treatment with ravidasvir, a second-generation, pan-genotypic NS5A inhibitor; danoprevir, a macrocyclic noncovalent reversible NS3 protein inhibitor, boosted with ritonavir; and ribavirin.
At 12 weeks, all patients achieved SVR with no virologic breakthrough during treatment. One patient did not return for follow-up at 24 weeks. The other 37 patients remained in SVR at 24 weeks.
All patients showed rapid decline of serum HCV RNA levels: 16 patients achieved HCV RNA levels less than the lower limit of quantification at week 2 and all 38 achieved virologic response by week 8.
Additionally, the researchers observed consistent virologic response in patients with or without NS3/4A resistance-associated amino acid variants.
Ravidasvir plus ritonavir-boosted danoprevir with ribavirin was safe and well-tolerated. The researchers observed no deaths, treatment-related serious adverse events or discontinuations related to adverse events.
The most common treatment-related adverse events included anemia (26.3%), diarrhea (15.8%), rash (13.2%), upper respiratory tract infection (10.5%), fatigue (10.5%) and cough (10.5%). Three patients had adverse events that led to dose reductions of ribavirin. – by Talitha Bennett
Disclosure: Kao reports he was a consultant for Abbott, AbbVie, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Merck Sharp & Dohme, Novartis and Roche; and was on the speakers bureau for Abbott, Roche, Bayer, Bristol-Myers Squibb, GlaxoSmithKline and Novartis. Please see the full study for the other authors’ relevant financial disclosures.