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100 naïve CHC patients concomitant with hepatocellular carcinoma without clinical evidence of HCC recurrence more than 3 months after curative treatments.

100 naïve CHC patients without malignancy

They received peginterferon alpha-2a (180 μg/week) and weight-based ribavirin 1000-1200 mg/day, with a 24-week follow-up period.

peginterferon alpha-2a and ribavirin

Wan-Long Chuang, MD

Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in chronic hepatitis C patients concomitant with hepatocellular carcinoma deserve to be elucidated.

The purposes of this study are:

1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.
2. To investigate the role of baseline and on-treatment factors on the response to pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.

A prospective, hospital-based study enrolling 100 chronic hepatitis C patients concomitant with hepatocellular carcinoma and other sex- and age-matched 100 chronic hepatitis C patients without malignancy will be conducted. The 100 chronic hepatitis C patients concomitant with hepatocellular carcinoma will receive pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after oncological treatments and/or interventions. The other 100 chronic hepatitis C patients without malignancy receiving the same antiviral therapy will serve as controls. The primary outcome measurement is sustained virological response and safety, whilst the secondary measurement is rapid virological and early virological response.

Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

Kaohsiung Medical University Chung-Ho Memorial Hospital

Wan-Long Chuang, MD.

Patient will be contacted for automated reminders within one month before the six-month interval indicating they are due for HCC screening.

The patient navigator will coordinate with the provider and subject to schedule the appropriate office visit and imaging for HCC screening as needed within one month before the test is due.

At the time consent is obtained, members of the research team will collect data about how a subject prefers to be contacted for automated reminders (i.e. text messages, postcard, email, MyChart)

Automated reminders

The patient navigator will attempt to provide a reminder to the subject one to three days before the scheduled imaging and also offer to accompany the subject to the test.

Patient navigation

Ponni Perumalswami, MD

Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV) infection in the United States have advanced liver disease. Patients with advanced fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are clinically cured of HCV continue to have an elevated risk of developing hepatocellular carcinoma (HCC). According to guidelines from several professional societies and from the American Association for the Study of Liver Diseases (AASLD), in particular, patients with advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening has risen dramatically in recent years due to the confluence of three factors: Increased screening for HCV, which has allowed more people to realize that they have this often "silent" infection; the availability of safe and highly effective direct acting antiviral drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to achieve an SVR; and the long duration of HCV infection in many patients, which has allowed enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in the era of DAAs and to promote HCC screening, the objective of this study is to conduct a randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC screening between patients randomized to either personalized patient navigation or automated reminders (e.g. electronic or mailed). Both interventions represent improved care over current standard of care (no patient navigation or automated reminders). There is no evidence to suggest one intervention is better than the other. Healthcare providers who agree to participate in the study will be contacted to confirm the liver disease status of their patients and during the clinical trial the providers of patients in both arms of the trial will be sent reminders about the need to schedule patients for screening visits.

Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening

Ratio of Number of on-time screening visits to number of missed screening visits

Percentage for patients completing timely screening visit

Icahn School of Medicine at Mount Sinai

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Hepatocellular Carcinoma	NCT00834860	Chronic Hepatit... Hepatocellular ...	peginterferon a...	18 Years -	Kaohsiung Medical University Chung-Ho Memorial Hospital
Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening	NCT02833298	Hepatocellular ... HCC Hepatitis C HCV	Automated remin... Patient navigat...	21 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for sustained virological response