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

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ClinicalTrials.gov Identifier: NCT03888729
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Partners in Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: sofosbubir/velpatasvir Drug: sofosbubir/velpatasvir/voxilaprevir Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be assigned to one of the following two groups in parallel for the duration of the study, based on treatment indication to be put on SOF/VEL or SOF/VEL/VOX:

  • sofosbubir/velpatasvir (SOF/VEL) FDC once daily for 12 weeks will be administered to HCV-infected individuals naïve to DAA therapy regimen (in this group we consider also HCV-infected individuals who have failed interferon-based therapy) who meet other eligibility criteria;
  • sofosbubir/velpatasvir /voxilaprevir (SOF/VEL/VOX) FDC once daily for 12 weeks will be administered to HCV treatment-experienced participants (i.e. HCV-infected individuals with a history of virologic failure to SOF/LDV or other DAA-containing regimen) who meet other eligibility criteria.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Vosevi




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888729


Contacts
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Contact: Fabienne Shumbusho, MD +250788559065 Fshumbusho@pih.org

Locations
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Rwanda
Rwanda Military Hospital Recruiting
Kigali, Rwanda
Contact: Fabienne Shumbusho    +250788559065 ext +250788559065    Fshumbusho@pih.org   
Sponsors and Collaborators
Partners in Health
Investigators
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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 of Results:
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Responsible Party: Partners in Health
ClinicalTrials.gov Identifier: NCT03888729    
Other Study ID Numbers: PartnersIH
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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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
Keywords provided by Partners in Health:
Hepatitis C
direct-acting antiviral
Rwanda
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Velpatasvir
Antiviral Agents
Anti-Infective Agents