Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

• Status: Completed
• Trial end date: 2020-08-28
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Partners in Health
• Treatments: Antiviral Agents; Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Inclusion Criteria:

• patients that are willing and able to provide written informed consent

• age ≥ 18 years

• HCV RNA ≥ 103 IU/mL

• HCV genotype 1 or 4

• screening ultrasound excluding hepatocellular carcinoma (HCC)

• acceptable laboratory values (hemoglobin ≥8.0 g/dL, platelet count ≥40,000/mm3; AST, ALT, and alkaline phosphatase ≤10 × ULN; creatinine clearance ≥30 mL/min)

• general good health

• ability to comply with study procedures

• HIV-infected patients must have completed at least 6 months of any approved HIV antiretroviral therapy (ART) per Rwanda National Guidelines 2013, have been taking for at least 2 weeks prior to screening ART compatible with SOF/LDV (efavirenz, rilpivirine, raltegravir, dolutegravir, emtricitabine, lamivudine, zidovudine, tenofovir), have screening HIV RNA < 200 copies/mL, and have screening CD4 T-cell count of ≥100 cells/µL

Exclusion Criteria:

• current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)

• active tuberculosis

• other clinically-significant illness (except HCV and/or HIV) or any other major medical disorder

• active Hepatitis B infection

• difficulty with blood collection and/or poor venous access for the purposes of phlebotomy

• any IFN-containing regimen within 8 weeks prior to screening or any prior exposure to HCV-specific direct-acting antiviral agent (other than a NS3/4A protease inhibitor and SOF), current pregnancy or breastfeeding, and active drug or alcohol use or dependence