A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection
Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid
substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with
genotype 1a infection or cirrhosis will receive 12 weeks of open-label
paritaprevir/ritonavir/ombitasvir and dasabuvir ("3D"), and twice-daily ribavirin.
Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label
"3D". The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and
follow-up phase (96 weeks) to evaluate treatment response and reinfection.