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

NCT04768517 | Unknown

• 1 other identifier: 202012260RIND
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 7

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.

Conditions

Hepatitis C Virus Infection; Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus (HIV) Coinfection

Keywords

Hepatitis C virus; Human immunodeficiency virus; Sustained virologic response; Reinfection

Outcome Measures

Primary Outcomes (1)

• Cumulative reinfection rate

  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

  Through study completion, an average of 3 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV/HCV-coinfected patients who undergo antiviral therapy for hepatitis C virus infection and who achieve sustained virologic response

You may qualify if:

• 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

You may not qualify if:

• Poor access to sites for venipuncture

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (7)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, 640, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Taipei City Hospital, Ren-Ai Branch

Taipei, 10629, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome; Coinfection; Reinfection

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; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chen-Hua Liu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Hua Liu, MD

CONTACT

+886-223123456; jacque_liu@mail2000.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: February 9, 2021
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

TW (7)