Hepatitis CPhase 3HCVreeNCT02785666

Swiss HCVree Trial

A Phase 3 study testing grazoprevir/elbasvir, ribavirin and Behavioural Intervention in people with Hepatitis C and HIV, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hepatitis C, HIV
What is being tested?: grazoprevir/elbasvir, ribavirin and Behavioural Intervention
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteSwitzerland
Study dates: Jun 2016to Aug 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 18Show fewer

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.
Participant has clinically-relevant drug or alcohol abuse at the PI's discretion within 12 months of screening.
Participant is a male whose female partner(s) is/are pregnant (this is a contraindication for ribavirin use)
Participant has exclusionary laboratory values at the screening visit (for the table containing these laboratory values we refer to the according section of this protocol).

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich
Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase III, Multi-center, Open-label Trial to Investigate the Impact of a Treat, Counsel and Cure Strategy in Men Who Have Sex With Men With Hepatitis C Infection in the Swiss HIV Cohort Study

Read the detailed description

The prevalence of hepatitis C virus (HCV) infection is increasing in HIV-positive men who have sex with men (MSM) participating in the Swiss HIV Cohort Study (SHCS). MSM with high-risk sexual behaviour are recognized to be the main drivers of the current HCV epidemic. However, in Switzerland treatment with the newest available direct acting agents (DAAs) is currently restricted to patients with a METAVIR fibrosis score ≥2 (i.e., patients with beginning or advanced liver fibrosis or cirrhosis) by the federal office of public health due to the tremendous costs of these DAAs. Within the study population (i.e. HIV-infected MSM with a replicating HCV-infection in Switzerland), about 90% of individuals have a METAVIR fibrosis score <2. As a consequence, HCV therapy with new DAAs is not covered by health insurances for the majority of this population. However, there is evidence that HCV treatment should not be delayed until the development of advanced liver disease. Treating HIV/HCV-coinfected individuals independently of their liver fibrosis score can prevent the development of liver related complications and the transmission of HCV infection.

The once daily oral combination regimen grazoprevir/elbasvir was approved by the Food and Drug Administration (FDA) in January 2016 for the treatment of genotype (GT) 1 and 4 HCV infection in mono- and HIV/HCV coinfected patients. In phase III clinical trial, a 12-week course of grazoprevir/elbasvir showed high efficacy with sustained virologic response (SVR) rates of ≥95%, and favourable tolerability. A 16 weeks treatment with grazoprevir/elbasvir in combination with weight-adjusted ribavirin is necessary in GT 1a infected patients with baseline resistance associated variants (RAV's) and GT 4 infected patients with a history of prior failure to HCV-treatment. Grazoprevir/elbasvir has only robust data from phase 2 and 3 clinical trials for GT 1, 4 HCV infections.

Of note, GT 1, 4 infections account for ~90% of HCV infections in the MSM population in the SHCS.

HCV reinfection remains a concern among MSM, who can be re-exposed to HCV through high-risk sexual behaviours after successful HCV treatment. A recent review shows evidence that behavioural interventions in high risk MSM have the potential to be effective at least in short term reduction of sexual risk behaviours.

To date the knowledge about the HCV-specific immune responses during DAA treatment is sparse. An effective adaptive cellular immunity is known to play a crucial role in spontaneous viral eradication after primary infection.

Conditions: Hepatitis C, HIV
Being tested: grazoprevir/elbasvir, ribavirin, Behavioural Intervention
Keywords: Men who have sex with men, Elimination
Medical subject headings: Hepatitis C, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

grazoprevir/elbasvir, ribavirinDrug
Also called Zepatier, Rebetol
To investigate the virological efficacy and safety of grazoprevir/elbasvir ±ribavirin for HIV/HCV-coinfected MSM with a GT 1 and/or 4 infection
Behavioural InterventionBehavioural
To counsel the targeted population with a behavioral intervention regarding the reduction of sexual risk behaviour and recreational drug use.

Study groups in NCT02785666
Study group	Role	What they receive
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 Receives: Drug: grazoprevir/elbasvir, ribavirin; Behavioral: Behavioural Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
AE will be assessed at every study-visit using standardized AE forms from the electronic case Report form
Measured: 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
Changes in condom use will be assessed as mediators for behaviour change. The behavioral intervention will be evaluated as a case-control study with the behavioural intervention as the exposure and a switch from "reporting condom-less sex" to "not reporting condom-less sex" as the outcome.
Measured: At week 0, week 12, and week 24.
Change in recreational drug use before and after the behavioural intervention
Changes in recreational drug use will be assessed as mediators for behaviour change. The behavioral intervention will be evaluated as a case-control study with the behavioural intervention as the exposure and a switch from "reporting recreational drug use" to "not reporting recreational drug use" as the outcome.
Measured: At week 0, week 12, and week 24.
Change in condom use attitude before and after the behavioural intervention
Changes in attitude of condom use use will be assessed as mediators for behaviour change. The behavioral intervention will be evaluated as a case-control study with the behavioural intervention as the exposure and a switch from "reporting condom-less sex" to "not reporting condom-less sex" as the outcom
Measured: At week 0, week 12, and week 24.
Change in condom use self-efficacy before and after the behavioural intervention
Changes in attitude of condom use self-efficacy will be assessed as mediators for behaviour change. The behavioral intervention will be evaluated as a case-control study with the behavioural intervention as the exposure and a switch from "reporting condom-less sex" to "not reporting condom-less sex" as the outcom
Measured: At week 0, week 12, and week 24.
Change in condom use behaviour before and after the behavioural intervention
Changes in attitude of condom use will be assessed as mediators for behaviour change. The behavioral intervention will be evaluated as a case-control study with the behavioural intervention as the exposure and a switch from "reporting condom-less sex" to "not reporting condom-less sex" as the outcom
Measured: At week 0, week 12, and week 24.
Change in recreational drug use attitude before and after the behavioural intervention
Changes in recreational drug use attitude will be assessed as mediators for behaviour change. The behavioral intervention will be evaluated as a case-control study with the behavioural intervention as the exposure and a switch from "reporting recreational drug use" to "not reporting recreational drug use" as the outcome.
Measured: At week 0, week 12, and week 24.
Change in recreational drug use behaviour before and after the behavioural intervention
Changes in recreational drug use behaviour will be assessed as mediators for behaviour change. The behavioral intervention will be evaluated as a case-control study with the behavioural intervention as the exposure and a switch from "reporting recreational drug use" to "not reporting recreational drug use" as the outcome.
Measured: At week 0, week 12, and week 24.
Change in recreational drug use self-efficacy before and after the behavioural intervention
Changes in recreational drug use self-efficacy will be assessed as mediators for behaviour change. The behavioral intervention will be evaluated as a case-control study with the behavioural intervention as the exposure and a switch from "reporting recreational drug use" to "not reporting recreational drug use" as the outcome.
Measured: At week 0, week 12, and week 24.
HCV treatment uptake: proportion of potentially eligible MSM participating in this study.
Treatment uptake will be compared according to demographical and clinical characteristics. Descriptive statistics will be used to assess risk factors for not initiating HCV therapy.
Measured: At week 0
Identification of presumed places of HCV acquisition and modes of HCV transmission: evaluation of patient's questionnaires
All patients will fill out an patient questionnaire at visit 1 where they are asked to provide information on the potential transmission mode (e.g., unprotected anal intercourse, intravenous drug use) of the HCV infection and the presumed places of acquisition (e.g. foreign country, Switzerland, city). This questionnairs will be analysed qualitatively.
Measured: At week 0
Barriers to treatment: systematic documentation of exclusion reasons for HCV treatment by patient's questionnaire
Reasons not to start HCV treatment will be compared according to demographical and clinical characteristics. Descriptive statistics will be used to assess risk factors for not initiating HCV therapy.
Measured: At week 0
Adherence to HCV treatment: proportion of patients which are adherent to ≥95% of prescribed pills
Adherence will be defined as the proportion of study drug doses taken. Acceptable adherence will be met if at least 95% of the prescribed tablets are taken. Predictors of non-adherence will be assessed using logistic regression and adherence will be included as an explanatory variable into the model evaluating predictors of the primary outcome.
Measured: At week 0, week 4, week 6, week 8, week 12, and week 24.
Impact of resistance associated variants: SVR 12 in GT 1a infected individuals stratified by presence of baseline RAV's.
In every patient with a GT 1a HCV infection a HCV resistance test will pe performed to determine resistance associated variants (RAV's) at baseline. Based on the presence of baseline RAVs the treatment duration will be prolonged to 16 weeks in addition to ribavirin as add-on to grazoprevir/elbasvir. The SVR 12 rates will then be analysed comparing the patients with and without baseline RAVs.
Measured: At week 24, i.e. 12 weeks after treament stopp
Assessment of HCV-specific cellular immune response: changes of HCV-specific T-cell functionality by ex vivo fluorescence-activated cell sorting (FACS) before and after DAA therapy
For the assessment of the cellular immune responses descriptive statistics will be used to compare changes before and after medical intervention and regression analysis to assess the influence of the immune responses on treatment failure and HCV re-infection.
Measured: At week 0, and week 24
Assessment of HCV-specific cellular immune response: changes of HCV-specific T-cell phenotype by ex vivo fluorescence-activated cell sorting (FACS) before and after DAA therapy
For the assessment of the cellular immune responses descriptive statistics will be used to compare changes before and after medical intervention and regression analysis to assess the influence of the immune responses on treatment failure and HCV re-infection.
Measured: At week 0, and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Aug 2018

First posted30 May 2016 (estimated)
Study startJun 2016
Primary completionApr 2018
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02785666
Sponsor's protocol ID: BASEC 2016-00131
Acronym: HCVree
Status last verified: Aug 2018
First submitted: 17 May 2016
Last updated: 31 Aug 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 35404384
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.
PubMed 33823783
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.
PubMed 32761122
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.
PubMed 31533734
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.
PubMed 30107494
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.
PubMed 30107485

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multi-center, Open-label Trial to Investigate the Impact of a Treat, Counsel and Cure Strategy in Men Who Have Sex With Men With Hepatitis C Infection in the Swiss HIV Cohort Study
ClinicalTrials.gov ID: NCT02785666
Acronym / sponsor ID: HCVree / BASEC 2016-00131
Conditions: Hepatitis C, HIV
Keywords: Men who have sex with men, Elimination
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: University of ZurichUniversity, hospital or other
Study start: Jun 2016
Primary completion: Apr 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 30 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Of note, GT 1, 4 infections account for ~90% of HCV infections in the MSM population in the SHCS.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment and behavioural intervention:	Experimental	Drug: grazoprevir/elbasvir, ribavirin, Behavioral: Behavioural InterventionTreatment 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

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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).

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
grazoprevir/elbasvir, ribavirinAlso: Zepatier, RebetolTo investigate the virological efficacy and safety of grazoprevir/elbasvir ±ribavirin for HIV/HCV-coinfected MSM with a GT 1 and/or 4 infection	Drug	Treatment and behavioural intervention:
Behavioural InterventionTo counsel the targeted population with a behavioral intervention regarding the reduction of sexual risk behaviour and recreational drug use.	Behavioural	Treatment and behavioural intervention:

Primary outcome

Virological efficacy of grazoprevir/elbasvir ±ribavirin: SVR rates at week 12 after treatment stop.
Time frame: 12 weeks after treatment stopp, i.e. week 24.
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.

16 secondary outcomes

Safety of grazoprevir/elbasvir ±ribavirin: frequency of adverse events and serious adverse events.
Time frame: 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
Time frame: At week 0, week 12, and week 24.
Change in recreational drug use before and after the behavioural intervention
Time frame: At week 0, week 12, and week 24.
Change in condom use attitude before and after the behavioural intervention
Time frame: At week 0, week 12, and week 24.
Change in condom use self-efficacy before and after the behavioural intervention
Time frame: At week 0, week 12, and week 24.
Change in condom use behaviour before and after the behavioural intervention
Time frame: At week 0, week 12, and week 24.
Change in recreational drug use attitude before and after the behavioural intervention
Time frame: At week 0, week 12, and week 24.
Change in recreational drug use behaviour before and after the behavioural intervention
Time frame: At week 0, week 12, and week 24.
Change in recreational drug use self-efficacy before and after the behavioural intervention
Time frame: At week 0, week 12, and week 24.
HCV treatment uptake: proportion of potentially eligible MSM participating in this study.
Time frame: At week 0
Identification of presumed places of HCV acquisition and modes of HCV transmission: evaluation of patient's questionnaires
Time frame: At week 0
Barriers to treatment: systematic documentation of exclusion reasons for HCV treatment by patient's questionnaire
Time frame: At week 0
Adherence to HCV treatment: proportion of patients which are adherent to ≥95% of prescribed pills
Time frame: At week 0, week 4, week 6, week 8, week 12, and week 24.
Impact of resistance associated variants: SVR 12 in GT 1a infected individuals stratified by presence of baseline RAV's.
Time frame: At week 24, i.e. 12 weeks after treament stopp
Assessment of HCV-specific cellular immune response: changes of HCV-specific T-cell functionality by ex vivo fluorescence-activated cell sorting (FACS) before and after DAA therapy
Time frame: At week 0, and week 24
Assessment of HCV-specific cellular immune response: changes of HCV-specific T-cell phenotype by ex vivo fluorescence-activated cell sorting (FACS) before and after DAA therapy
Time frame: At week 0, and week 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Derived from this study: PubMed 35404384Kusejko 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.
Derived from this study: PubMed 33823783Kunzler-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.
Derived from this study: PubMed 32761122Braun 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.
Derived from this study: PubMed 31533734Kunzler-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.
Derived from this study: PubMed 30107494Braun 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.
Derived from this study: PubMed 30107485Braun 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dominique L Braun, MD principal investigator

University Hospital Zurich, University of Zurich

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing grazoprevir/elbasvir, ribavirin and Behavioural Intervention in people with Hepatitis C and HIV, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virological efficacy of grazoprevir/elbasvir ±ribavirin: SVR rates at week 12 after treatment stop. (time frame: 12 weeks after treatment stopp, i.e. week 24.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02785666, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.