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

NCT ID: NCT02964091

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-08-28

Brief 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.

Detailed Description

This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in HCV treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 HCV infection. Approximately 240 participants will be enrolled and treated with sofosbuvir (SOF) 400 mg/LDV 90 mg fixed dose combination (FDC) one tablet once daily for 12 weeks in the SHARED 1 study. Sixty additional participants will be enrolled in the SHARED 2 sub-cohort with laboratory monitoring blinded to study clinicians.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Harvoni

sofosbuvir/ledipasvir once daily for 12 weeks

Group Type: OTHER

sofosbuvir/ledipasvir

Intervention Type: DRUG

Interventions

sofosbuvir/ledipasvir

Intervention Type: DRUG

Other Intervention Names

Harvoni

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Partners in Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Partners in Health

Jules Kabahizi, MD

Role: PRINCIPAL_INVESTIGATOR

Rwanda Military Hospital

Aimable Mbituyumuremyi, MD

Role: PRINCIPAL_INVESTIGATOR

Rwanda Biomedical Centre

Philip Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Claude M Muvunyi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rwanda

Locations

Rwanda Military Hospital

Kanombe, Kigali, Rwanda

Countries

Rwanda

References

Gupta N, Mbituyumuremyi A, Kabahizi J, Ntaganda F, Muvunyi CM, Shumbusho F, Musabeyezu E, Mukabatsinda C, Ntirenganya C, Van Nuil JI, Kateera F, Camus G, Damascene MJ, Nsanzimana S, Mukherjee J, Grant PM. Treatment of chronic hepatitis C virus infection in Rwanda with ledipasvir-sofosbuvir (SHARED): a single-arm trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):119-126. doi: 10.1016/S2468-1253(18)30382-0. Epub 2018 Dec 11.

Reference Type: DERIVED

PMID: 30552056 (View on PubMed)

Other Identifiers

SHARED 092415

Identifier Type: -

Identifier Source: org_study_id