Hepatitis C Virus InfectionNCT04768517
HCV Reinfection in in HIV/HCV-coinfected Patients Achieving SVR by Antiviral Therapy
An observational study of Hepatitis C Virus Infection and Hepatitis C Virus Infection, Response to Therapy of, run by National Taiwan University Hospital at 7 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis C Virus Infection, Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus (HIV) Coinfection
- How many people
- 300 participants
- Where
- 7 sitesTaiwan
- Study dates
- 9 Feb 2021to 1 Mar 2024
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV/HCV-coinfected patients who undergo antiviral therapy for hepatitis C virus infection and who achieve sustained virologic response
Who may be able to join
- 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
Who cannot join
- Poor access to sites for venipuncture
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites, 7 recruiting
- Recruiting
National Taiwan University Hospital, Yun-Lin Branch
Douliu, 640
Chen-Hua Liu, MD, +886-972651880, jacque_liu@mail2000.com.tw
- Recruiting
China Medical University Hospital
Taichung, 40447
Cheng-Yuan Peng, MD, +886422052121, cypeng@mail.cmuh.org.tw
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Sheng-Shun Yang, MD, +886423592525, yansh@vghtc.gov.tw
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Chen-Hua Liu, MD, +886-223123456 ext. 63572, jacque_liu@mail2000.com.tw
- Recruiting
Taipei City Hospital, Ren-Ai Branch
Taipei, 10629
Chih-Lin Lin, MD, +886227093600, DAB53@tpech.gov.tw
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Wei-Yu Kao, MD, +886227372181, 121021@tmuh.org.tw
- Recruiting
Tri-Service General Hospital
Taipei
Yu-Lueng Shih, MD, +886287923311, albreb@ms28.hinet.net
About this study
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
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.
Read the 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.
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
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome, Coinfection, Reinfection
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start9 Feb 2021
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen-Hua Liu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768517
- Sponsor's protocol ID
- 202012260RIND
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04768517
- Acronym / sponsor ID
- 202012260RIND
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 24 Feb 2021 (actual)
- 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.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV/HCV-coinfected patients who undergo antiviral therapy for hepatitis C virus infection and who achieve sustained virologic response
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Poor access to sites for venipuncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative reinfection rate
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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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.
Chen-Hua Liu, MD principal investigator
National Taiwan University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus Infection and Hepatitis C Virus Infection, Response to Therapy of, run by National Taiwan University Hospital at 7 sites in Taiwan.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Hua Liu, MD (+886-223123456 ext. 63572, jacque_liu@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative reinfection rate (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2021.