Patients with hepatitis C Virus who had not previously had treatment or responded to treatment displayed sustained virologic response in phase 2b of a new study.
All-oral regimens of antiviral agents and ribavirin were effective in patients with hepatitis C Virus (HCV) genotype 1 infection who had not previously received therapy and also in those who had not had a response to prior therapy. This is according to results from a phase 2b of a study published online in The New England Journal of Medicine.
Scientists tested 571 patients without cirrhosis who had either not received previous treatment or who had not responded to prior treatment. They were assigned to a regimen of ABT-450/r, combined with ABT-267 or ABT-333 or both, for 8, 12 or 24 weeks. Each patient received at least one dose of therapy. All but 1 of the 14 treatment subgroups also received ribavirin (the dose was determined by body weight). The primary end point was sustained virologic response at 24 weeks after the end of the treatment. The primary efficacy analysis compared rates between previously untreated patients who received three direct-acting antiviral agents and ribavirin for 8 weeks and those who received the same therapy for 12 weeks.
For patients previously untreated who received three direct-acting antiviral agents plus ribavirin, the rate of sustained virologic response at 24 weeks after treatment was 88% and 95% for those who received therapy for 8 and 12 weeks, respectively. Across all subgroups, sustained virologic response rates ranged from 83% to 100%. The most frequent side effects included fatigue, headache, nausea, and insomnia. Eight patients in the study (1%) discontinued treatment because of the side effects.
The effects ribavirin had on HCV patients in this study also supports what scientists in Taiwan have concluded: antiviral therapy for HCV improves kidney and cardiovascular outcomes for patients with diabetes. “Our findings suggest that HCV may cause clinical complications related to diabetes. But these issues are mitigated by HCV antiviral therapy, specifically pegylated interferon plus ribavirin, which was found to reduce risks of kidney disease, stroke and cardiovascular diseases in diabetic patients,” Chun-Ying Wu, MD, PhD, MPH, from Taichung Veterans General Hospital in Taiwan, lead author, explained in a press release.