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peginterferon alfa-2a for the treatment of chronic hepatitis C in the era of direct-acting antivirals

Hepatobiliary & Pancreatic Diseases International 2017年第5期16卷 470-479页

作者： Yan Huang Ming-Hui Li Min Hou Yao Xie Shanghai Roche Pharmaceuticals Ltd. Shanghai 201203 China Liver Disease Center Beijing Ditan Hospital Capital Medical University Beijing 100015 China

BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained virological response (SVR). Nevertheless, the majority of patients globally are unable to access these treatments because of cost and infrastructure constraints and, thus, remain untreated and uncured. DATA SOURCE: Relevant articles of peginterferon (PegIFN)-based treatments in HCV and sofosbuvir-based treatments, simeprevir, daclatasvir/asunaprevir, ritonavir-boosted paritaprevir/ombitasvir/dasabuvir, and grazoprevir/elbasvir, were searched in PubMed database, including general population and special population. RESULTS: PegIFN in combination with ribavirin remains an important and relevant option for some patients, achieving SVR rates of up to 79% in genotype 1 and 89% in genotype 2 or 3 infections, which increases for patients with favorable IL28B genotypes. Triple therapy of DAA plus PegIFN/ribavirin is effective in treating difficult-to-cure patients infected with HCV genotype 3 or with resistance-associated variants. Owing to its long history in HCV management, the efficacy, tolerability and long-term outcomes associated with PegIFN alfa-2a are well established and have been validated in large-scale studies and in clinical practice for many populations. Furthermore, emerging data show that IFN-induced SVR is associated with lower incidences of hepatocellular carcinoma compared with DAAs. On the contrary, novel DAAs have yet to be studied in special populations, and long-term outcomes, particularly tumor development and recurrence in patients with cirrhosis and/or hepatocellular carcinoma, and reactivation of HBV in dually infected patients, are still unclear. CONCLUSION: In this interferon-free era, PegIFN-based regimens remain a safe and effective option for selected HCV patients.

关键词： chronic hepatitis C direct-acting antivirals hepatitis C virus peginterferon alfa-2a ribavirin

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Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients： A Randomized, Multicenter, Phase IIIb Open-Label Study （POTENT Study）

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Chinese Medical Journal 2018年第14期131卷 1645-1651页

作者： Dae Won Jun Sang Bong Ahn Tae Yeob Kim Joo Hyun Sohn Sang Gyune Kim Se Whan Lee Byung Ho Kim Dong Joon Kim Ja Kyung Kim Hyoung Su Kim Seong Gyu Hwang Won Choong Choi Won Young Tak Heon Ju Lee Ki Tae Yoon Byung Cheol Yun Sung Wook Lee Soon Koo Baik Seung Ha Park Ji Won Park Sol Ji Park Ji Sung Lee Department of Internal Medicine Hanyang University Seoul Hospital Hanyang University Seou104763 Korea Department of Internal Medicine Nowon Eulji Hospital Eulji University Seou101830 Korea Department of Internal Medicine Hanyang University Guri Hospital Hanyang University Guri 11923 Korea Department of Internal Medicine SoonChunHyang University Bucheon Hospital SoonChunHyang University Bucheon 14584 Korea Department of Internal Medicine SoonChunHyang University Cheonan Hospital SoonChunHyang University Cheonan 31151 Korea Department of Internal Medicine Kyung Hee University Hospital Kyung Hee University Seoul 02453 Korea Department of Internal Medicine Chuncheon Sacred Heart Hospital Hallym University Chuncheon 24252 Korea Department of Internal Medicine Kangdong Sacred Heart Hospital Hallym University Seou105355 Korea Department of Internal Medicine Gangnam Severance Hospital Yonsei University Seou106273 Korea Department of Internal Medicine CHA Bundang Medical Center CHA University Seongnam 13496 Korea Department of Internal Medicine Sanggye Paik Hospital Inje University Seoul 01757 Korea Department of Internal Medicine Kyungpook National University Hospital Kyungpook National University Daegu 41944 Korea Department of Internal Medicine Yeungnam University Medical Center Yeungnam University Daegu 42415 Korea Department of Internal Medicine Pusan National University Yangsan Hospital Pusan National University Yangsan 50612 Korea Department of Internal Medicine Kosin University Gospel Hospital Kosin University Pusan 49267 Korea Department of Internal Medicine Dong A University Medical Center Dong A University Pusan 49201 Korea Department of Internal Medicine Wonju Severance Christian Hospital Yonsei University Wonju 26426 Korea Department of Internal Medicine Haeundae Paik Hospital Inje University Pusan 48108 Korea Department of Internal Medicine Hallym University Sacred Heart Hospital Hallym University Anyang 14068 Korea Department of Cli

Background： Until now, various types of combined therapy with nucleotide analogs and pegylated interferon （Peg-INF） in patients with hepatitis B patients have been tried. Howe6ver, studies regarding the benefits of de novo combination, late-add on, and sequential treatmentare very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment. Methods： Between June 2010 and June 2015, hepatitis 13 e antigen （HBeAg）-positive patients （n = 162） received Peg-IFN for 48 weeks （mono-treatment group, n = 81） and entecavir （ETV） for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy （sequential treatment group, n = 81）. The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher＇s exact test, and regression analysis.Results： HBeAg seroconversion rate （18.2% vs. 18.2%, t = 0.03, P = 1.000） and seroclearance rate （19.7% vs. 19.7%, t = 0.03, P = 1.000） were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase （ALT） normalization （45.5% vs. 54.5%, t = 1.12, P = 0.296） and serum hepatitis B virus （HBV）-DNA 〈2000 U/L （28.8% vs. 28.8%, t = 0.10, P = 1.000） was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate （HBeAg seroconversion and serum HBV-DNA 〈2000 U/L） was not different in the two groups （12.1% vs. 16.7%, t = 1.83, P = 0.457）. Baseline HBV-DNA level （7 log10 U/ml vs. 7.5 log10 U/ml, t = 1.70, P = 0.019） and hepatitis B surface antigen titer （3.6 log10 U/ml vs. 4.0 log10 U/ml, t = 2.19, P = 0.020） were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively. Conclusions： The current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.

关键词： Entecavir Hepatitis B peginterferon alfa-2a

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Sustained Responses in Chronic Hepatitis B Patients with Nucleos(t)ide Analogue Drug-resistance after Peg-interferon alfa-2a Add-on Treatment:A Long-term Cohort Study

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Journal of Clinical and Translational Hepatology 2018年第1期6卷 18-24页

作者： Yunhua Liu Weikun Li Ting Jia Dan Peng Huimin Li Xiaofei Li Songqin Lv The Third People's Hospital of Kunming City KunmingChina Department of Liver Disease The Third People's Hospital of Kunming CityKunming 650041China

Background and Aims:The use of additional nucleos(t)ide analogues(NAs)without cross-resistance to previously used NAs as a rescue therapy is recommended by most international guidelines for chronic hepatitis B patients with NAresistance.We aimed to investigate the efficacy and safety of combination therapy of peg-interferon(PegIFN)alfa-2a and NA in these patients,comparing to those who switch to an alternative NA therapy without cross-resistance.Methods:In this prospective,comparative and cohort study,data were collected from the patients'hospital records.Eligible patients were those with hepatitis B e antigen(HBeAg)positivity and resistance to one or more NAs.All patients were treated with alternative NA alone or in combination with PegIFN alfa-2a for 52 weeks or 72 weeks,respectively.HBeAg seroconversion was measured at the end of follow-up(EOF;more than 104 weeks after the end of treatment).Results:Sixty-three patients were recruited to the cohort study(NAtherapy group=31 patients;combination therapy group of NA and PegIFN alfa-2a=32 patients).At the EOF,significantly more patients in the combination therapy group(13/27,48.2%)achieved primary outcome of HBeAg seroconversion than those in the NA therapy group(4/32,12.5%)(p=0.003).Four patients(14.8%)in the combination therapy group achieved hepatitis B surface antigen(HBsAg)loss and HBsAg seroconversion,but none in the NA therapy group did(p=0.039).In the combination therapy group,16 patients(51.6%)achieved HBeAg seroconversion at the end of treatment,of which,11 patients(68.8%)maintained the response until EOF.Conclusions:Adding on PegIFN alfa-2a in combination with NA therapy might be an appropriate rescue treatment option for patients who have prior NA resistance.In addition,combination therapy induced sustained off-treatment biochemical responses in these patients.

关键词： Chronic hepatitis B peginterferon alfa-2a NA drug resistance HBeAg seroconversion Cohort study

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