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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 4

Locations

Rwanda

Study Type

Interventional

Intervention

sofosbuvir/ledipasvir

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C Virus, sofosbuvir/ledipasvir, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rwanda Military Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Harvoni

Arm Description

sofosbuvir/ledipasvir once daily for 12 weeks

Outcomes

Primary Outcome Measures

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.

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.

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

Secondary Outcome Measures

A set of minimum required monitoring tests

Distribution of HCV genotypes subtypes among participants

SVR12, stratified by genotypic subtype

Basic demographic and clinical characteristics of patients referred for HCV treatment

Adherence to SOF/LDV measured by pill count

Proportion of participants with virologic failure

Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment

Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment

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

Full Information

NCT ID

NCT02964091

First Posted

November 3, 2016

Last Updated

September 14, 2021

Sponsor

Partners in Health

1. Study Identification

Unique Protocol Identification Number

NCT02964091

Brief Title

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

Acronym

SHARED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

August 28, 2020 (Actual)

Study Completion Date

August 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Partners in Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

Hepatitis C Virus, sofosbuvir/ledipasvir, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Harvoni

Arm Type

Other

Arm Description

sofosbuvir/ledipasvir once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

sofosbuvir/ledipasvir

Other Intervention Name(s)

Harvoni

Primary Outcome Measure Information:

Title

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

Description

Time Frame

After study completion (24 weeks)

Title

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

Description

Time Frame

After study completion (24 weeks)

Title

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

Description

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

Time Frame

After study completion (24 weeks)

Secondary Outcome Measure Information:

Title

A set of minimum required monitoring tests

Description

A set of minimum required monitoring tests

Time Frame

After study completion (24 weeks)

Title

Distribution of HCV genotypes subtypes among participants

Description

Distribution of HCV genotypes subtypes among participants

Time Frame

After study completion (24 weeks)

Title

SVR12, stratified by genotypic subtype

Description

SVR12, stratified by genotypic subtype

Time Frame

After study completion (24 weeks)

Title

Basic demographic and clinical characteristics of patients referred for HCV treatment

Description

Basic demographic and clinical characteristics of patients referred for HCV treatment

Time Frame

After study completion (24 weeks)

Title

Adherence to SOF/LDV measured by pill count

Description

Adherence to SOF/LDV measured by pill count

Time Frame

After 12 weeks medication therapy

Title

Proportion of participants with virologic failure

Description

Proportion of participants with virologic failure

Time Frame

After study completion (24 weeks)

Title

Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment

Description

Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment

Time Frame

After study completion (24 weeks)

Title

Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment

Description

Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment

Time Frame

After 12 weeks of medication therapy

Title

Proportion of participants reporting increased quality of life after SVR12 using the Medical Outcomes Study HIV Health Survey

Description

To determine the effect of SOF/LDV and SVR12 on quality of life in Rwanda

Time Frame

After study completion (24 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Gupta, MD

Organizational Affiliation

Partners in Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jules Kabahizi, MD

Organizational Affiliation

Rwanda Military Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Aimable Mbituyumuremyi, MD

Organizational Affiliation

Rwanda Biomedical Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Philip Grant, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Claude M Muvunyi, MD

Organizational Affiliation

University of Rwanda

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rwanda Military Hospital

City

Kanombe

State/Province

Kigali

ZIP/Postal Code

00000

Country

Rwanda

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The study protocol, study data, data dictionary, data collection instruments, and informed consent forms are available upon request from the corresponding author. De-identifiable individual participant data will be made available 9 months after the publication date and ending 36 months after the publication date. 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.

IPD Sharing 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.

IPD Sharing 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.

Citations:

PubMed Identifier

30552056

Citation

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.

Results Reference

derived

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

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