C-WORTHY: Grazoprevir/elbasvir regimen yielded high SVR rates in patients with HCV genotype 1
BOSTON — A number of patients with hepatitis C virus genotype 1 infection, with and without cirrhosis, and patients coinfected with HIV and HCV, achieved sustained virologic response at 12 weeks when treated with grazoprevir and elbasvir, with or without ribavirin, according to data from the phase 2 trial of the C-WORTHY study presented at The Liver Meeting.
“Grazoprevir and elbasvir, with or without ribavirin, demonstrated high efficacy,” Eric J. Lawitz, MD, of The Texas Liver Institute, University of Texas Health Science Center, San Antonio, said in the hepatitis plenary. “High efficacy was achieved regardless of the presence or absence of ribavirin or extended treatment duration from 12 to 18 weeks.”
Eric J. Lawitz
Treatment-naive patients with HCV genotype 1 and cirrhosis (n=123) and patients previously treated with pegylated interferon and ribavirin (n=130), with or without cirrhosis, were treated with grazoprevir and elbasvir (MK-5172, MK-8742; Merck) with (63 naive, 65 experienced) or without ribavirin (60 naive, 65 experienced) for 12 or 18 weeks. Each group of patients had at least 90% sustained virologic response rate at 12 weeks (SVR12) and minimal virologic failure, only six in the treatment naive group and four in the treatment experienced group. Virologic breakthrough was observed in one treatment naive patient who received treatment with ribavirin for 12 weeks and a treatment experienced patient who underwent treatment without ribavirin for 18 weeks. The most common adverse events (AE) were fatigue (26%), headache (23%) and asthenia (14%) and no treatment was discontinued due to AEs.
Treatment-naive patients mono-infected with HCV genotype 1 without cirrhosis (n=129) and patients coinfected with HIV and HCV without cirrhosis (n=59) were treated with grazoprevir and elbasvir with or without ribavirin for 12 weeks. In addition, 30 patients with mono-infected HCV were treated with grazoprevir and elbasvir plus ribavirin for 8 weeks. Ninety-three percent of HCV mono-infected patients treated with ribavirin and 98% treated without ribavirin experienced SVR12, HIV/HCV coinfected patients treated with ribavirin yielded a 97% SVR12 rate and 87% treated without ribavirin experienced SVR12. Among the patients in the 12-week groups, there was a 4% overall rate of virologic failure (7/188). In the 8-week group, 5 patients experienced virologic failure. The most common adverse events were fatigue (23%), headache (20%), nausea (15%) and diarrhea (10%). No discontinuations due to adverse events were observed.
“Grazoprevir and elbasvir were generally safe and well-tolerated,” Lawitz said. – by Melinda Stevens
For more information:
Lawitz E. Abstract 196. Presented at: The Liver Meeting, Nov. 7-11, 2014; Boston, MA.
Disclosures: See the abstract for a full list of relevant financial disclosures.