Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sofosbuvir and Daclatasvir Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks. |
Drug: sofosbuvir and daclatasvir
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
Other Names:
|
| Active Comparator: Ledipasvir/sofosbuvir Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks. |
Drug: ledipasvir/sofosbuvir
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.
once daily;
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy [Post treatment Week 12]
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication
- Incidence of adverse events leading to permanent discontinuation of study drug [Baseline up to Week 12]
Secondary Outcome Measures
- Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment [Baseline up to Week 12]
- HCV RNA levels and change during and after treatment [Baseline up to Week 12]
- Treatment adherence [Baseline to Week 12]
To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)
- Change in health related quality of life [Baseline to Week 24]
To evaluate the change in health-related quality of life during treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;
-
Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
-
HCV RNA > 10,000 IU/mL at Screening;
-
Screening laboratory values within defined thresholds;
-
Negative pregnancy test at baseline (females of childbearing potential only);
-
Use of two effective contraception methods if female of childbearing potential or sexually active male.
Exclusion Criteria:
-
Pregnant or nursing female;
-
HIV infection or HBV infection (HBcAb and HBsAg positive);
-
Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
-
Active or recent history (≤ 1 year) of drug or alcohol abuse;
-
Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital | Beijing | Beijing | China | 100039 |
| 2 | Humanity and Health GI and Liver Centre | Hong Kong | Hong Kong | China | 00852 |
Sponsors and Collaborators
- Humanity and Health Research Centre
- Beijing 302 Hospital
Investigators
- Principal Investigator: George Lau, MD, Humanity and Health GI and Liver Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H&H_HCV G3 Study