Simplifying HCV Treatment in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3) (SHARED3)

September 10, 2019 updated by: Partners in Health

Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)

The main purpose of the study is to determine the antiviral efficacy and evaluate the safety and tolerability of sofosbuvir/ velpatasvir (SOF/VEL) and sofosbuvir/ velpatasvir/ voxilaprevir (SOF/VEL/VOX) used to treat individuals with chronic hepatitis C virus infection in Rwanda adults.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is an open-label single-arm study that will examine the antiviral efficacy, safety and tolerability of 12 weeks daily therapy with fixed dose combination (FDC) of SOF/VEL and SOF/VEL/VOX administered respectively in HCV-infected treatment-naïve adult participants and in HCV-infected individuals with a history of virologic failure to SOF/LDV or other DAA-containing regimen. A total of 100 participants will be enrolled in this portion of the SHARED study, labelled the "SHARED 3 study": 60 treatment-naïve participants and 40 individuals with history of virologic failure to SOF/LDV or other DAA-containing regimen

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Kigali, Rwanda
        • Recruiting
        • Rwanda Military Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Age ≥ 18 years
  • HCV RNA >1000 IU/mL at Screening
  • For SOF/VEL arm, HCV treatment-naïve or interferon/ribavirin-experienced
  • For SOF/VEL/VOX arm, history of virologic failure to SOF/LDV or other DAA-containing regimen as defined by a quantifiable HCV viral load any time at or after the end of HCV therapy
  • Screening ultrasound excluding hepatocellular carcinoma (HCC)

  • Acceptable laboratory values including:

    • Hemoglobin ≥8.0 g/dL
    • Platelet count ≥40,000/mm3
    • AST, ALT, and alkaline phosphatase ≤10 × ULN
    • Calculated creatinine clearance (CrCl) ≥30 mL/min
  • General good health
  • Ability to comply with the dosing instructions for study drug administration and to complete the study schedule of assessments

  • If HIV-infected:

    • The participant must have completed at least 6 months of any approved HIV antiretroviral therapy (ART) before starting enrollment
    • The participant at time of screening and for at least 2 weeks prior to screening must be on ART compatible with SOF/VEL and SOF/VEL/VOX
    • Screening HIV RNA < 200 copies/mL
    • Screening CD4 T-cell count of ≥100 cells/µL
  • Women of reproductive potential must have a negative urine pregnancy test at Screening and a negative urine pregnancy test at Entry prior to enrollment.

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 that, in the opinion of the site investigator, may interfere with participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically-significant illness (other than HCV/HIV) are also excluded.
  • Active Hepatitis B infection
  • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
  • Pregnant or nursing female
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study procedures and treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HCV treatment-naïve participants
HCV-infected individuals naïve to DAA therapy regimen; in this group we consider also HCV-infected individuals who have failed interferon-based therapy. Sofosbubir/velpatasvir (SOF/VEL) will be administered once daily for 12 weeks to eligible HCV treatment-naïve participants.
Drug: sofosbubir/velpatasvir
SOF/VEL (400 mg/100 mg) FDC once daily
Other Names:
  • Epclusa
EXPERIMENTAL: HCV treatment-experienced participants
HCV treatment-experienced participants, i.e.HCV-infected individuals with a history of virologic failure to SOF/LDV or other DAA-containing regimen. Sofosbubir/velpatasvir /voxilaprevir (SOF/VEL/VOX) will be administered once daily for 12 weeks to eligible HCV treatment-experienced participants
Drug: sofosbubir/velpatasvir/voxilaprevir
SOF/VEL/VOX (400 mg/100 mg/100 mg) FDC once daily
Other Names:
  • Vosevi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12)
Time Frame: After study completion (week 24)
Antiviral efficacy of SOF/VEL FDC and SOF/VEL/VOX 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 (week 24)
Proportion of patients treated with SOF/VEL FDC and SOF/VEL/VOX FDC with a new grade 3 or 4 adverse event as defined by the DAIDS Scales or with premature study drug discontinuation due to an adverse event
Time Frame: After study completion (week 24)
Proportion of patients treated with SOF/VEL FDC and SOF/VEL/VOX FDC with a new grade 3 or 4 adverse event as defined by the DAIDS Scales or with premature study drug discontinuation due to an adverse event
After study completion (week 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants by HCV genotype subtypes with SVR12 after completing treatment with SOF/VEL FDC and SOF/VEL/VOX FDC
Time Frame: After study completion (week 24)
Proportion of participants by HCV genotype 4 subtype with SVR12 after completing the study treatment with SOF/VEL FDC and SOF/VEL/VOX FDC
After study completion (week 24)
Adherence to SOF/VEL FDC and SOF/VEL/VOX FDC
Time Frame: After study completion (week 24)
Proportion of participants with adequate adherence to SOF/VEL FDC and SOF/VEL/VOX FDC measured by pill count >90% of pills taken
After study completion (week 24)
Odds ratio for achievement of SVR12 by treatment type for the following variables: age (per 10 year increase), female sex, HIV co-infection, genotype subtype 4r, baseline HCV viral load (per 1 log increase), APRI > 1.0
Time Frame: After study completion (week 24)
Odds ratio for achievement of SVR12 by treatment type for the following variables: age (per 10 year increase), female sex, HIV co-infection, genotype subtype 4r, baseline HCV viral load (per 1 log increase), APRI > 1.0
After study completion (week 24)
Proportion of HIV co-infected subjects that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment
Time Frame: After study completion (week 24)
Proportion of HIV co-infected subjects that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment, with HIV-1 RNA test performed at completion of the study treatment (week 12)
After study completion (week 24)
Effect of SOF/VEL FDC and SOF/VEL/VOX FDC and SVR12 on quality of life
Time Frame: After study completion (week 24)
Effect of SOF/VEL FDC and SOF/VEL/VOX FDC and SVR12 on quality of life, using the MOS HIV questionnaire, with proportion of patients showing significant improvement on physical quality of life and mental quality of life from pre- to post- treatment
After study completion (week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Partners in Health

Investigators

  • Principal Investigator: Neil Gupta, MD, MPH, Partners In Health; Brigham and Women's Hospital; Harvard Medical School
  • Principal Investigator: Fredrick Kateera, MD, PhD, Partners In Health/Inshuti Mu Buzima - Rwanda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 26, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (ACTUAL)

March 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PartnersIH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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