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

Chronic Hepatitis C Clinical Trial

— SHARED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964091
• Other study ID #: SHARED 092415
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: August 28, 2020

Study information

• Verified date: September 2021
• Source: Partners in Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 28, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• sofosbuvir/ledipasvir

Locations

Country	Name	City	State
Rwanda	Rwanda Military Hospital	Kanombe	Kigali

Sponsors (1)

Lead Sponsor	Collaborator
Partners in Health

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	A set of minimum required monitoring tests	A set of minimum required monitoring tests	After study completion (24 weeks)
Secondary	Distribution of HCV genotypes subtypes among participants	Distribution of HCV genotypes subtypes among participants	After study completion (24 weeks)
Secondary	SVR12, stratified by genotypic subtype	SVR12, stratified by genotypic subtype	After study completion (24 weeks)
Secondary	Basic demographic and clinical characteristics of patients referred for HCV treatment	Basic demographic and clinical characteristics of patients referred for HCV treatment	After study completion (24 weeks)
Secondary	Adherence to SOF/LDV measured by pill count	Adherence to SOF/LDV measured by pill count	After 12 weeks medication therapy
Secondary	Proportion of participants with virologic failure	Proportion of participants with virologic failure	After study completion (24 weeks)
Secondary	Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment	Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment	After study completion (24 weeks)
Secondary	Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment	Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment	After 12 weeks of medication therapy
Secondary	Proportion of participants reporting increased quality of life after SVR12 using the Medical Outcomes Study HIV Health Survey	To determine the effect of SOF/LDV and SVR12 on quality of life in Rwanda	After study completion (24 weeks)