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

NCT02964091 | Completed Phase 4 DMC

• 1 other identifier: SHARED 092415
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C Virus; sofosbuvir/ledipasvir; Efficacy

Outcome Measures

Primary Outcomes (3)

• Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment

  To determine the hepatitis C virus (HCV) antiviral efficacy of sofosbuvir/ledipasvir (SOF/LDV) fixed-dose combination (FDC) as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12) in Rwanda.

  After study completion (24 weeks)

• Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment, with limited lab monitoring

  To determine the HCV antiviral efficacy of SOF/LDV FDC, as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12), with limited lab monitoring in Rwanda.

  After study completion (24 weeks)

• Proportion of participants with a new grade 3 or 4 adverse event or premature study drug discontinuation due to an adverse event.

  To evaluate the safety and tolerability of SOF/LDV FDC in Rwanda

  After study completion (24 weeks)

Secondary Outcomes (9)

• A set of minimum required monitoring tests

  After study completion (24 weeks)

• Distribution of HCV genotypes subtypes among participants

  After study completion (24 weeks)

• SVR12, stratified by genotypic subtype

  After study completion (24 weeks)

• Basic demographic and clinical characteristics of patients referred for HCV treatment

  After study completion (24 weeks)

• Adherence to SOF/LDV measured by pill count

  After 12 weeks medication therapy

Study Arms (1)

Harvoni

OTHER

sofosbuvir/ledipasvir once daily for 12 weeks

Drug: sofosbuvir/ledipasvir

Interventions

sofosbuvir/ledipasvir DRUG

Also known as: Harvoni

Harvoni

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Partners in Health: lead

Study Sites (1)

Rwanda Military Hospital

Kanombe, Kigali, 00000, Rwanda

Location

Related Publications (1)

• 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.

  PMID: 30552056 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neil Gupta, MD

  Partners in Health

  PRINCIPAL INVESTIGATOR

• Jules Kabahizi, MD

  Rwanda Military Hospital

  PRINCIPAL INVESTIGATOR

• Aimable Mbituyumuremyi, MD

  Rwanda Biomedical Centre

  PRINCIPAL INVESTIGATOR

• Philip Grant, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Claude M Muvunyi, MD

  University of Rwanda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 15, 2016
• Study Start: October 1, 2016
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identifiable individual participant data will be made available 9 months after the publication date and ending 36 months after the publication date.
• Access Criteria: Forms and data can be accessed by written request to the corresponding author and the study sponsor, Partners In Health. The data will be made available following evaluation and approval of proposed use by the study sponsor and signed data access agreement with the study sponsor.

Locations

RW (1)