Dataset Information

Durable virological response and functional cure of chronic hepatitis D after long-term peginterferon therapy.

ABSTRACT:

Background

Hepatitis delta virus (HDV) infection is the most aggressive form of chronic viral hepatitis. Response rates to therapy with 1- to 2-year courses of pegylated interferon alpha (peginterferon) treatment are suboptimal.

Aims

To evaluate the long-term outcomes of patients with chronic hepatitis D after an extended course of peginterferon.

Methods

Patients were followed after completion of trial NCT00023322 and classified based on virological response defined as loss of detectable serum HDV RNA at last follow-up. During extended follow-up, survival and liver-related events were recorded.

Results

All 12 patients who received more than 6 months of peginterferon in the original study were included in this analysis. The cohort was mostly white (83%) and male (92%) and ranged in age from 18 to 58 years (mean = 42.6). Most patients had advanced but compensated liver disease at baseline, a median HBV DNA level of 536 IU per mL and median HDV RNA level of 6.86 log₁₀ genome equivalents per mL. The treatment duration averaged 6.1 years (range 0.8-14.3) with a total follow-up of 8.8 years (range 1.7-17.6). At last follow-up, seven (58%) patients had durable undetectable HDV RNA in serum, and four (33%) cleared HBsAg. Overall, one of seven (14%) responders died or had a liver-related event vs four of five (80%) non-responders.

Conclusions

With further follow-up, an extended course of peginterferon therapy was found to result in sustained clearance of HDV RNA and favourable clinical outcomes in more than half of patients and loss of HBsAg in a third.

SUBMITTER: Hercun J

PROVIDER: S-EPMC9969742 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Publications

Durable virological response and functional cure of chronic hepatitis D after long-term peginterferon therapy.

Hercun Julian J Kim Grace E GE Da Ben L BL Rotman Yaron Y Kleiner David E DE Chang Richard R Glenn Jeffrey S JS Hoofnagle Jay H JH Koh Christopher C Heller Theo T

Alimentary pharmacology & therapeutics 20210528 2

<h4>Background</h4>Hepatitis delta virus (HDV) infection is the most aggressive form of chronic viral hepatitis. Response rates to therapy with 1- to 2-year courses of pegylated interferon alpha (peginterferon) treatment are suboptimal.<h4>Aims</h4>To evaluate the long-term outcomes of patients with chronic hepatitis D after an extended course of peginterferon.<h4>Methods</h4>Patients were followed after completion of trial NCT00023322 and classified based on virological response defined as loss ...[more]

PMID: 34048594

Similar Datasets

Project description:BackgroundIn patients with chronic hepatitis C who do not have a response to antiviral treatment, the disease may progress to cirrhosis, liver failure, hepatocellular carcinoma, and death. Whether long-term antiviral therapy can prevent progressive liver disease in such patients remains uncertain.MethodsWe conducted a randomized, controlled trial of peginterferon alfa-2a at a dosage of 90 microg per week for 3.5 years, as compared with no treatment, in 1050 patients with chronic hepatitis C and advanced fibrosis who had not had a response to previous therapy with peginterferon and ribavirin. The patients, who were stratified according to stage of fibrosis (622 with noncirrhotic fibrosis and 428 with cirrhosis), were seen at 3-month intervals and underwent liver biopsy at 1.5 and 3.5 years after randomization. The primary end point was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points.ResultsWe randomly assigned the patients to receive peginterferon (517 patients) or no therapy (533 patients) for 3.5 years. The level of serum aminotransferases, the level of serum hepatitis C virus RNA, and histologic necroinflammatory scores all decreased significantly (P<0.001) with treatment, but there was no significant difference between the groups in the rate of any primary outcome (34.1% in the treatment group and 33.8% in the control group; hazard ratio, 1.01; 95% confidence interval, 0.81 to 1.27; P=0.90). The percentage of patients with at least one serious adverse event was 38.6% in the treatment group and 31.8% in the control group (P=0.07).ConclusionsLong-term therapy with peginterferon did not reduce the rate of disease progression in patients with chronic hepatitis C and advanced fibrosis, with or without cirrhosis, who had not had a response to initial treatment with peginterferon and ribavirin. (ClinicalTrials.gov number, NCT00006164.)

Dataset Information

Durable virological response and functional cure of chronic hepatitis D after long-term peginterferon therapy.

Background

Aims

Methods

Results

Conclusions

Publications

Durable virological response and functional cure of chronic hepatitis D after long-term peginterferon therapy.

Similar Datasets

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