Hepatitis C HIV Coinfection

 

The Swiss HCVree Trial: The vision of a hepatitis C free Switzerland

 


Background of the Swiss HCVree Trial

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. 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 HCV drugs (DAAs) is currently restricted to patients with beginning or advanced liver fibrosis or cirrhosis (i.e., METAVIR fibrosis score ≥2) due to the tremendous costs by the federal office of public health. In the SHCS about 90% of HIV-infected MSM with a replicating HCV-infection have a METAVIR fibrosis score <2. As a consequence, HCV treatment with new DAAs is not covered by health insurances for the majority of this population.

Aims of the Swiss HCVree Trial

The Swiss HCVree trial aims at providing a HCV treatment to all HIV/HCV-positive MSM in Switzerland with the goal to prevent the development of liver related complications and to interrupt the transmission chain of HCV infection in the MSM community. Together with the possibility to treat chronic HCV infections of individuals which have been infected by intravenous drug use with an advanced liver fibrosis, the Swiss HCVree Trial pursues the vison of a hepatitis C free Switzerland.

Study procedures

The Swiss HCVree Trial is leaded by PD Dr. Jan Fehr and Dr. Dominique Braun from the Department of Infectious Diseases and Hospital Epidemiology from the University Hospital Zurich and is conducted in all seven centres participating in the SHCS. From October 1st 2015 to March 31th 2016 all HIV-positive MSM in the SHCS will undergo intensified HCV-screening by ultrasensitive HCV testing to detect a replicating HCV infection in this population. Thereafter, from April 1st to December 31th 2016 interferon-free HCV treatment with a highly effective, once daily combination regimen DAA will be offered to all MSM with a replicating HCV infection. Data shows that a 12 or 16 week course with the combination regimen DAA used in the Swiss HCVree Trial results in high HCV curing rates of ≥95%. The treatment period will be accompanied by an intensified risk-behaviour counselling to limit the risk of HCV re-infection after succesfull treatment. After the treatment period, from January 1st to March 31th 2017 the number of replicating HCV infection will be re-assessed in the same population.

New insights of the Swiss HCVree Trial

The Swiss HCVree Trial will allow to assess the impact of a treatment intervention on HCV prevalence and liver-related diseases in a nation-wide representative population. The proposed intervention will inform national and international guideline panels regarding the best strategies to combat the HCV epidemic. For example, treatment recommendations could change from todays practice to focus on those with advanced liver disease to individuals in earlier stages of HCV-infection especially in those most likely to further transmit HCV infection to uninfected partners. Additionally, the Swiss HCVree Trial will assess the burden of disease, quality of life and its improvement as a consequence of successful treatment. Thereby we would be in position to show a benefit on the level of the society in addition to an individual level. This could serve as an important argument for payers and health authorities of the usefulness of a timely treatment.

Publications

• Wandeler G, Dufour JF, Bruggmann P, Rauch A. Hepatitis C: a changing epidemic. Swiss Med Wkly 2015;145:w14093.
• Wandeler G, Gsponer T, Bregenzer A, et al. Hepatitis C virus infections in the Swiss HIV Cohort Study: a rapidly evolving epidemic. Clin Infect Dis 2012;55:1408-16.

Information and Registry

Tel.+41 44 255 33 22
Fax +41 44 255 44 99

Team

• PD Dr. med. Jan Fehr, attending physician, Department of Infectious Diseases and Hospital Epidemiology
• Dr. med. Dominique Braun, attending physician, Department of Infectious Diseases and Hospital Epidemiology


Research collaboration

• www.shcs.ch
• http://www.hepatitis-schweiz.ch

Contact address

Department of Infectious Diseases and Hospital Epidemiology
PD Dr. J. Fehr
University Hospital Zurich
Rämistrasse 100
8091 Zürich

Hepatitis C viremia and the risk of non-liver-related morbidity and mortality in HIV-infected individuals

Background
Apart from liver disease HCV has been associated with extrahepatic morbidities, including kidney, bone-related, metabolic and cardiovascular diseases. Besides the contribution of lifestyle-related risk factors associated with HCV-exposure   (intravenous drug use, alcohol, poor nutrition), replicating HCV infection itself has been postulated as a contributing factor by promoting immune activation and inflammation.

Study Aims
1) To explore the contribution of replicating HCV infection to extrahepatic comorbidities and mortality by comparing patients with chronic HCV infection with those with spontaneous HCV clearance.
2) To investigate whether successful HCV treatment reduces the risk of extrahepatic comorbidities and mortality by comparing patients with SVR to patients with treatment failure.

Study Design
All HCV-seropositive SHCS participants with a follow-up visit since 2001 will be included. Associations of clinical events (liver, non-AIDS, cardiovascular, diabetes, malignancies, fractures, renal) and mortality with HCV stage (viremic/nonviremic, treated with/without SVR) will be analysed in Cox proportional hazards regression models.

 Publications
• Kovari H, Ledergerber B, Cavassini M, et al. High hepatic and extrahepatic mortality and low treatment uptake in HCV-coinfected persons in the Swiss HIV Cohort Study between 2001 and 2013. J Hepatol. 2015; 63: 573-580.

Corresponding Author
Division of Infectious Diseases and Hospital Epidemiology
Dr. Helen Kovari, University Hospital Zurich, University of Zurich
Rämistrasse 100
8091 Zürich, Switzerland