Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients

Humanity and Health Research Centre

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: SOF+DCV; Drug: SOF+RBV; Drug: LDV/SOF

Study type: Interventional

Funder types: Other

Identifiers

NCT02482077

H&H_HCV G2 Study

Details and patient eligibility

About

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 genotypes 2 infection.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;
2. Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
3. HCV RNA > 10,000 IU/mL at Screening;
4. Screening laboratory values within defined thresholds
5. Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

1. Pregnant or nursing female or male with pregnant female partner;
2. HIV or chronic hepatitis B virus (HBV) infection;
3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
4. Active or recent history (≤ 1 year) of drug or alcohol abuse;
5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

112 participants in 6 patient groups

SOF+RBV 8 wk

Experimental group

Description:

Participants will receive SOF+RBV for 8 weeks.

Treatment:

Drug: SOF+RBV

SOF+RBV 12 wk

Experimental group

Description:

Participants will receive SOF+RBV for 12 weeks.

Treatment:

Drug: SOF+RBV

SOF+DCV 8 wk

Experimental group

Description:

Participants will receive SOF+DCV for 8 weeks.

Treatment:

Drug: SOF+DCV

SOF+DCV 12 wk

Experimental group

Description:

Participants will receive SOF+DCV for 12 weeks.

Treatment:

Drug: SOF+DCV

LDV/SOF 8 wk

Experimental group

Description:

Participants will receive LDV/SOF for 8 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF 12 wk

Experimental group

Description:

Participants will receive LDV/SOF for 12 weeks.

Treatment:

Drug: LDV/SOF