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

NCT ID: NCT03888729

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2020-03-31

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.

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

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

sofosbubir/velpatasvir

Intervention Type: DRUG

SOF/VEL (400 mg/100 mg) FDC once daily

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

Group Type: EXPERIMENTAL

sofosbubir/velpatasvir/voxilaprevir

Intervention Type: DRUG

SOF/VEL/VOX (400 mg/100 mg/100 mg) FDC once daily

Interventions

sofosbubir/velpatasvir

SOF/VEL (400 mg/100 mg) FDC once daily

Intervention Type: DRUG

sofosbubir/velpatasvir/voxilaprevir

SOF/VEL/VOX (400 mg/100 mg/100 mg) FDC once daily

Intervention Type: DRUG

Other Intervention Names

Epclusa; Vosevi

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Partners in Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Gupta, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Partners In Health; Brigham and Women's Hospital; Harvard Medical School

Fredrick Kateera, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Partners In Health/Inshuti Mu Buzima - Rwanda

Locations

Rwanda Military Hospital

Kigali, , Rwanda

Site Status: RECRUITING

Countries

Rwanda

Central Contacts

Fabienne Shumbusho, MD

Role: CONTACT

Fshumbusho@pih.org

+250788559065

Facility Contacts

Fabienne Shumbusho

Role: primary

Fshumbusho@pih.org

+250788559065 ext. +250788559065

References

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.

Reference Type: RESULT

PMID: 30552056 (View on PubMed)

Kateera F, Shumbusho F, Manirambona L, Kabihizi J, Murangwa A, Serumondo J, Makuza JD, Nsanzimana S, Muvunyi CM, Kabakambira JD, Sylvain H, Camus G, Grant PM, Gupta N. Safety and efficacy of sofosbuvir-velpatasvir to treat chronic hepatitis C virus infection in treatment-naive patients in Rwanda (SHARED-3): a single-arm trial. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):533-541. doi: 10.1016/S2468-1253(21)00398-8. Epub 2022 Mar 3.

Reference Type: DERIVED

PMID: 35248213 (View on PubMed)

Gupta N, Manirambona L, Shumbusho F, Kabihizi J, Murangwa A, Serumondo J, Makuza JD, Nsanzimana S, Muvunyi CM, Mukabatsinda C, Musabeyezu E, Camus G, Grant PM, Kateera F. Safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):542-551. doi: 10.1016/S2468-1253(21)00399-X. Epub 2022 Mar 3.

Reference Type: DERIVED

PMID: 35248212 (View on PubMed)

Other Identifiers

PartnersIH

Identifier Type: -

Identifier Source: org_study_id