NCT02634008

Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P

An Open Label, Multicentre, International Pilot Study of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir With or Without Ribavirin or Glecaprevir/Pibrentasvir for People With Recently Acquired Hepatitis C Virus Infection With or Without HIV Co-infection.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.

Detailed description

The use of a highly potent IFN-sparing drug combination in the setting of recently acquired 1 HCV infection is hypothesised to result in the vast majority of patients achieving SVR. In this setting, it is anticipated that therapy can be shortened relative to that used in established chronic infection. A short course IFN-free strategy is likely to be highly attractive to both patients and clinicians and if proven may further encourage early HCV testing and diagnosis. In this pilot study, the investigators plan to explore the safety, efficacy and feasibility of the IFN-sparing combination for treatment of recently acquired HCV infection. Cohort One: paritaprevir/ritonavir/ombitasvir, dasabuvir with/without ribavirin (HCV genotype 1 only) Cohort Two (and Three): glecaprevir/pibrentasvir (HCV genotypes 1-6)

Conditions

• Hepatitis C, Acute

Interventions

Type	Name	Description
DRUG	Paritaprevir/ritonavir/ombitasvir
DRUG	Dasabuvir
DRUG	Ribavirin
DRUG	Glecaprevir/pibrentasvir

Timeline

• Start date: 2016-06-01
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2015-12-17
• Last updated: 2022-08-22

Locations

11 sites across 3 countries: Australia, New Zealand, United Kingdom