HCV Reinfection in in HIV/HCV-coinfected Patients Achieving SVR by Antiviral Therapy

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04768517

Collaborator

(none)

300

Enrollment

Locations

36.7

Anticipated Duration (Months)

42.9

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic hepatitis C virus (HCV) infection remains a health burden in people living with human immunodeficiency virus (HIV). Interferon (IFN)-based therapy is the treatment of choice for HCV infection for HIV coinfected patients in earlier years. However, the treatment responses are far from ideal and the treatment-emergent adverse events (AEs) are frequently encountered. Based on the excellent efficacy and safety, IFN-free direct acting antivirals (DAAs) have been the mainstay of therapy for HCV. Furthermore, the world health organization (WHO) has set the goal of global HCV elimination by 2030. The microelimination of HCV among HIV/HCV-coinfected patients is also listed as the prioritized target by WHO. Although the overall treatment response has improved dramatically during the past 5-10 years, several studies have indicated the HIV/HCV-coinfected patients had high risks of reinfection following successful antiviral treatment. The risk of HCV reinfection was reported to be 24.6% among HIV-positive men who have sex with men (MSM) in Austria, German, France and the United Kingdom who attained sustained virologic response (SVR) by IFN-based therapy. Two recent studies from Canada showed that the incidence of HCV reinfection in HIV-positive patients was higher that HIV-negative patients (3.44 vs. 1.13 per 100 person-year; 2.56 vs. 1.12 per 100 person-year). In Taiwan, 14.1% of the HIV-positive patients had HCV reinfection following treatment-induced or spontaneous viral clearance, resulting an incidence of 8.2 per 100 person-year with a total of 218.3 person-years of follow-up for these patients.

Because data regarding to the HCV reinfection in HIV-positive patients are still limited, where a more comprehensive assessment of HCV reinfection is important based on the perspectives of HCV microelimination among HIV-positive patients in Taiwan, the investigators thus aim to conduct a long-term, large-scale cohort study to assess the risk of HCV reinfection in HIV-positive patients achieving SVR after IFN-based or IFN-free therapies, and to assess the factors associated with different risks of reinfection in these patients.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection Hepatitis C Virus Infection, Response to Therapy of Human Immunodeficiency Virus (HIV) Coinfection

Detailed Description

Chronic hepatitis C virus (HCV) infection remains a health burden in people living with human immunodeficiency virus (HIV). Compared to the midpoint prevalence rate of HCV coinfection to be 2.4% in the general HIV-positive population, the prevalence rates are higher among bisexual men (4.0%), gay men (6.4%), and people who inject drugs (PWIDs) (82.4%). Following the widespread use of antiretroviral therapy (ART) for HIV which improves the health outcome by reducing the acquired immunodeficiency syndrome (AIDS)-related deaths, the liver-related death has become a frequent cause of non-AIDS-related deaths in HIV-positive population. If HCV is left untreated, the HIV/HCV-coinfected patients may have higher risks of developing hepatic decompensation or hepatocellular carcinoma (HCC) than HCV-monoinfected patients due to the accelerated progression of hepatic fibrosis.

Interferon (IFN)-based therapy is the treatment of choice for HCV infection for HIV coinfected patients in earlier years. However, the treatment responses are far from ideal and the treatment-emergent adverse events (AEs) are frequently encountered. Based on the excellent efficacy and safety, IFN-free direct acting antivirals (DAAs) have been the mainstay of therapy for HCV. Furthermore, the world health organization (WHO) has set the goal of global HCV elimination by 2030. The microelimination of HCV among HIV/HCV-coinfected patients is also listed as the prioritized target by WHO.

Although the overall treatment response has improved dramatically during the past 5-10 years, several studies have indicated the HIV/HCV-coinfected patients had high risks of reinfection following successful antiviral treatment. The risk of HCV reinfection was reported to be 24.6% among HIV-positive men who have sex with men (MSM) in Austria, German, France and the United Kingdom who attained sustained virologic response (SVR) by IFN-based therapy. Two recent studies from Canada showed that the incidence of HCV reinfection in HIV-positive patients was higher that HIV-negative patients (3.44 vs. 1.13 per 100 person-year; 2.56 vs. 1.12 per 100 person-year). In Taiwan, 14.1% of the HIV-positive patients had HCV reinfection following treatment-induced or spontaneous viral clearance, resulting an incidence of 8.2 per 100 person-year with a total of 218.3 person-years of follow-up for these patients.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Risk of Hepatitis C Virus Reinfection in Human Immunodeficiency Virus and Hepatitis C Virus Coinfected Patients Achieving Sustained Virologic Response by Antiviral Therapy

Actual Study Start Date :

Feb 9, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Outcome Measures

Primary Outcome Measures

Cumulative reinfection rate [Through study completion, an average of 3 years]
Time-dependent accumulative proportion of participants with evidence of resurgence of HCV viremia from the time point of viral clearance after antiviral therapy to the time point of last follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age old than 20 years old
Patients with human immunodeficiency virus coinfection (HIV) during IFN-based or IFN-free antiviral therapy for hepatitis C virus (HCV) infection
Patients achieving SVR, defined as undetectable serum HCV RNA at week 12 off-therapy

Exclusion Criteria:

Poor access to sites for venipuncture

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	National Taiwan University Hospital, Yun-Lin Branch	Douliu	Taiwan	640
2	China Medical University Hospital	Taichung	Taiwan	40447
3	Taichung Veterans General Hospital	Taichung	Taiwan	40705
4	National Taiwan University Hospital	Taipei	Taiwan	10002
5	Taipei City Hospital, Ren-Ai Branch	Taipei	Taiwan	10629
6	Taipei Medical University Hospital	Taipei	Taiwan	110
7	Tri-Service General Hospital	Taipei	Taiwan