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

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ClinicalTrials.gov Identifier: NCT02964091
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Partners in Health

Tracking Information
First Submitted Date  ICMJE November 3, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date June 28, 2018
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • 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 [ Time Frame: After study completion (24 weeks) ]
    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 [ Time Frame: After study completion (24 weeks) ]
    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. [ Time Frame: After study completion (24 weeks) ]
    To evaluate the safety and tolerability of SOF/LDV FDC in Rwanda
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • A set of minimum required monitoring tests [ Time Frame: After study completion (24 weeks) ]
  • Distribution of HCV genotypes subtypes among participants [ Time Frame: After study completion (24 weeks) ]
  • SVR12, stratified by genotypic subtype [ Time Frame: After study completion (24 weeks) ]
  • Basic demographic and clinical characteristics of patients referred for HCV treatment [ Time Frame: After study completion (24 weeks) ]
  • Adherence to SOF/LDV measured by pill count [ Time Frame: After 12 weeks medication therapy ]
  • Proportion of participants with virologic failure [ Time Frame: After study completion (24 weeks) ]
  • Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment [ Time Frame: After study completion (24 weeks) ]
  • 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 ]
  • Proportion of participants reporting increased quality of life after SVR12 using the Medical Outcomes Study HIV Health Survey [ Time Frame: After study completion (24 weeks) ]
    To determine the effect of SOF/LDV and SVR12 on quality of life in Rwanda
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World
Official Title  ICMJE Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE Drug: sofosbuvir/ledipasvir
Other Name: Harvoni
Study Arms  ICMJE Harvoni
sofosbuvir/ledipasvir once daily for 12 weeks
Intervention: Drug: sofosbuvir/ledipasvir
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Rwanda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02964091
Other Study ID Numbers  ICMJE SHARED 092415
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Partners in Health
Study Sponsor  ICMJE Partners in Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neil Gupta, MD Partners in Health
Principal Investigator: Jules Kabahizi, MD Rwanda Military Hospital
Principal Investigator: Aimable Mbituyumuremyi, MD Rwanda Biomedical Center
Principal Investigator: Philip Grant, MD Stanford University
Principal Investigator: Claude M Muvunyi, MD University of Rwanda
PRS Account Partners in Health
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP