Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-25 @ 9:13 PM
Study NCT ID:
NCT02785666
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swiss HCVree Trial
Sponsor:
University of Zurich
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCVree
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".
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.
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".
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.
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".
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: