Swiss HCVree Trial

NCT02785666 | Completed Phase 3

• 1 other identifier: BASEC 2016-00131
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim at investigating the efficacy of grazoprevir/elbasvir ±ribavirin in HIV-positive MSM participating in the SHCS in a broader setting of coinfected MSM. The study pursues a comprehensive approach of a treat, counsel and cure strategy exploring the impact of such a strategy in a representative HIV/HCV-coinfected MSM population. This study is a nested project of the Swiss HIV Cohort Study entitled "The Swiss HCVree Trial".

Conditions

Hepatitis C; HIV

Keywords

Men who have sex with men; Elimination

Outcome Measures

Primary Outcomes (1)

• Virological efficacy of grazoprevir/elbasvir ±ribavirin: SVR rates at week 12 after treatment stop.

  The main analysis will be the evaluation of SVR 12 weeks after end of treatment (SVR12). We will determine the proportion of patients with an SVR12 (HCV viral load\< 20 copies per ml) in intention to treat analyses including all patients who have received at least one dose of the study compound. Per protocol analyses will also be performed.

  12 weeks after treatment stopp, i.e. week 24.

Secondary Outcomes (16)

• Safety of grazoprevir/elbasvir ±ribavirin: frequency of adverse events and serious adverse events.

  At week 0, week 4, week 6, week 8, week 12, week 16, and week 24.

• Change in condom use before and after the behavioural Intervention

  At week 0, week 12, and week 24.

• Change in recreational drug use before and after the behavioural intervention

  At week 0, week 12, and week 24.

• Change in condom use attitude before and after the behavioural intervention

  At week 0, week 12, and week 24.

• Change in condom use self-efficacy before and after the behavioural intervention

  At week 0, week 12, and week 24.

Study Arms (1)

Treatment and behavioural intervention:

EXPERIMENTAL

Treatment intervention: Patients with a replicating GT 1 and/or 4 HCV infection without or with cirrhosis will be treated with grazoprevir/elbasvir (100mg/50mg) for 12 weeks. GT 1a infected patients with baseline RAV's and GT 4 infected patients with a history of prior HCV treatment failure without or with cirrhosis will be treated with the same regimen for 16 weeks, in combination with weight-adjusted ribavirin. Behavioural Intervention: Participants with inconsistent condom use with occasional partners will receive the behavioral Intervention and in addition standard of care written and oral information on prevention of HCV reinfection. Study participants with consistent condom use or those reporting inconsistent condom use with occasional partners but not willing to participate in the intervention will receive standard of care written and oral information on prevention of HCV reinfection only

Drug: grazoprevir/elbasvir, ribavirin; Behavioral: Behavioural Intervention

Interventions

grazoprevir/elbasvir, ribavirin DRUG

To investigate the virological efficacy and safety of grazoprevir/elbasvir ±ribavirin for HIV/HCV-coinfected MSM with a GT 1 and/or 4 infection

Also known as: Zepatier, Rebetol

Treatment and behavioural intervention:

Behavioural Intervention BEHAVIORAL

To counsel the targeted population with a behavioral intervention regarding the reduction of sexual risk behaviour and recreational drug use.

Treatment and behavioural intervention:

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent documented by signature
• Participation in the SHCS
• Male individual ≥18 years old
• Homosexual or bisexual preference/transmission mode according to the SHCS entry state and/or in the opinion of the study physician.
• Replicating HCV infection (i.e., positive HCV-RNA-test).
• HCV GT 1 and/or 4 infection.

You may not qualify if:

• Contraindications to grazoprevir/elbasvir and ribavirin due to significant drug-drug interactions (DDI) (e.g., HIV protease inhibitors) according to the Liverpool drug-interaction data base.
• Contraindications to grazoprevir/elbasvir and ribavirin, e.g. known hypersensitivity or allergy to the class of drugs or the investigational product.
• Participant is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
• Inability to follow the study procedures (e.g. language barriers, psychiatric disorders
• Known or suspected non-adherence to study-procedures.
• Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study.
• Enrolment of the investigator, his/her family members, employees and other dependent persons.
• Participant suffers from clinically significant concomitant diseases (for the detailed list of diseases we refer to the according section of this protocol).
• Participant has a history of malignancy ≤5 years prior to signing informed consent or is under evaluation for other active or suspected malignancy.
• Participant has a history of opportunistic infection in the preceding 6 months prior to screening.
• Participants with mixed HCV infection of genotype 1, 4 or 6 with genotype 2, 3 or 5.
• Participant is coinfected with HBV-DNA positive hepatitis B virus (of note, HBsAg positive individuals with suppressed HBV-DNA might be included).
• Participant has evidence of decompensated liver disease.
• Liver cirrhosis Child-Pugh Class B or C, or who have a Pugh-Turcotte (CPT) score \>5,
• Participant has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (6)

• Kusejko K, Salazar-Vizcaya L, Shah C, Stockle M, Beguelin C, Schmid P, Ongaro M, Darling K, Bernasconi E, Rauch A, Kouyos RD, Gunthard HF, Boni J, Fehr JS, Braun DL; Swiss HIV Cohort Study. Sustained Effect on Hepatitis C Elimination Among Men Who Have Sex With Men in the Swiss HIV Cohort Study: A Systematic Re-Screening for Hepatitis C RNA Two Years Following a Nation-Wide Elimination Program. Clin Infect Dis. 2022 Nov 14;75(10):1723-1731. doi: 10.1093/cid/ciac273.

  PMID: 35404384 DERIVED

• Kunzler-Heule P, Fierz K, Schmidt AJ, Rasi M, Bogdanovic J, Kocher A, Engberg S, Battegay M, Nostlinger C, Lehner A, Kouyos R, Schmid P, Braun DL, Fehr J, Nicca D. Response to a sexual risk reduction intervention provided in combination with hepatitis C treatment by HIV/HCV co-infected men who have sex with men: a reflexive thematic analysis. BMC Infect Dis. 2021 Apr 6;21(1):319. doi: 10.1186/s12879-021-06003-z.

  PMID: 33823783 DERIVED

• Braun DL, Hampel B, Ledergerber B, Grube C, Nguyen H, Kunzler-Heule P, Shah C, Salazar-Vizcaya L, Conen A, Flepp M, Stockle M, Beguelin C, Schmid P, Rougemont M, Delaloye J, Bernasconi E, Nicca D, Boni J, Rauch A, Kouyos RD, Gunthard HF, Fehr JS. A Treatment-as-Prevention Trial to Eliminate Hepatitis C Among Men Who Have Sex With Men Living With Human Immunodeficiency Virus (HIV) in the Swiss HIV Cohort Study. Clin Infect Dis. 2021 Oct 5;73(7):e2194-e2202. doi: 10.1093/cid/ciaa1124.

  PMID: 32761122 DERIVED

• Kunzler-Heule P, Engberg S, Battegay M, Schmidt AJ, Fierz K, Nguyen H, Kocher A, Nostlinger C, Hampel B, Stockle M, Beguelin C, Delaloye J, Schmid P, Flepp M, Rougement M, Braun DL, Fehr J, Nicca D; Swiss HIV Cohort Study (SHCS). Screening HIV-positive men who have sex with men for hepatitis C re-infection risk: is a single question on condom-use enough? A sensitivity analysis. BMC Infect Dis. 2019 Sep 18;19(1):821. doi: 10.1186/s12879-019-4456-7.

  PMID: 31533734 DERIVED

• Braun DL, Hampel B, Martin E, Kouyos R, Kusejko K, Grube C, Flepp M, Stockle M, Conen A, Beguelin C, Schmid P, Delaloye J, Rougemont M, Bernasconi E, Rauch A, Gunthard HF, Boni J, Fehr JS; Swiss HIV Cohort Study. High Number of Potential Transmitters Revealed in a Population-based Systematic Hepatitis C Virus RNA Screening Among Human Immunodeficiency Virus-infected Men Who Have Sex With Men. Clin Infect Dis. 2019 Feb 1;68(4):561-568. doi: 10.1093/cid/ciy545.

  PMID: 30107494 DERIVED

• Braun DL, Hampel B, Kouyos R, Nguyen H, Shah C, Flepp M, Stockle M, Conen A, Beguelin C, Kunzler-Heule P, Nicca D, Schmid P, Delaloye J, Rougemont M, Bernasconi E, Rauch A, Gunthard HF, Boni J, Fehr JS; Swiss HIV Cohort Study. High Cure Rates With Grazoprevir-Elbasvir With or Without Ribavirin Guided by Genotypic Resistance Testing Among Human Immunodeficiency Virus/Hepatitis C Virus-coinfected Men Who Have Sex With Men. Clin Infect Dis. 2019 Feb 1;68(4):569-576. doi: 10.1093/cid/ciy547.

  PMID: 30107485 DERIVED

MeSH Terms

Conditions

Hepatitis C; Homosexuality

Interventions

grazoprevir; elbasvir; Ribavirin; elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Dominique L Braun, MD

  University Hospital Zurich, University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 30, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)