Recommendations for the Clinical Management of Hepatitis C in Iran: A Consensus-Based National Guideline

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Abstract

Context

Hepatitis C virus (HCV) infection is a major public health issue worldwide, including Iran. The new direct-acting antiviral agents (DAAs) with high efficacy have changed the landscape of HCV treatment. This guideline provides updated recommendations for clinical management of HCV infection in Iran.

Evidence Acquisition

The recommendations of this guideline are based on international and national scientific evidences and consensus-based expert opinion. Scientific evidences were collected through a systematic review of studies that evaluated efficacy and safety of DAA regimens, using PubMed, Scopus and Web of Science. Expert opinion was based on the consensus of Iran Hepatitis Scientific Board (IHSB) in the 3 ^rd national consensus on management of Hepatitis C in Iran, held on 22 ^nd of July 2016.

Results

Pegylated Interferon alpha (PegIFN), Ribavirin (RBV), Sofosbuvir (SOF), Ledipasvir (LDV) and Daclatasvir (DCV) are currently available in Iran. Pre-treatment assessments include HCV RNA level, HCV genotype and resistance testing, assessment of liver fibrosis, and underlying diseases. In HCV genotype 1 and 4, DCV/SOF and LDV/SOF are recommended. In HCV genotype 2, SOF plus RBV and in HCV genotype 3, DCV/SOF is recommended. Additional care for underlying diseases should be considered.

Conclusions

Affordable new HCV treatment regimens are available in Iran, providing an opportunity for HCV elimination. Recommendations provided in this current national guideline can facilitate evidence-based management of HCV infection.

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Most cited references 67

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EASL Recommendations on Treatment of Hepatitis C 2015.

(2015)

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Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.

Kris V Kowdley, Stuart Gordon, K Rajender Reddy … (2014)

High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen. In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or ledipasvir-sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy. The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir-sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% (95% CI, 92 to 98) with 12 weeks of ledipasvir-sofosbuvir. As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir, the rate in the 12-week group was 1 percentage point higher (97.5% CI, -4 to 6) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower (95% CI, -6 to 4); these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen, on the basis of a noninferiority margin of 12 percentage points. Adverse events were more common in the group that received ribavirin than in the other two groups. No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events. Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis. No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks. (Funded by Gilead Sciences; ION-3 ClinicalTrials.gov number, NCT01851330.).

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Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.

Michael P Curry, Jacqueline G. O'Leary, Natalie H. Bzowej … (2015)

As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase.

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Author and article information

Journal

Journal ID (nlm-ta): Hepat Mon

Journal ID (iso-abbrev): Hepat Mon

Journal ID (doi): 10.5812/hepatmon

Journal ID (publisher-id): Kowsar

Title: Hepatitis Monthly

Publisher: Kowsar

ISSN (Print): 1735-143X

ISSN (Electronic): 1735-3408

Publication date (Electronic): 13 August 2016

Publication date Collection: August 2016

Volume: 16

Issue: 8

Electronic Location Identifier: e40959

Affiliations

[1 ]Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Baqiyatallah University of Medical Sciences, Tehran, IR Iran

[2 ]Middle East Liver Diseases (MELD) Center, Tehran, IR Iran

[3 ]Viral Hepatitis Clinical Research Program, The Kirby Institute, The University of New South Wales (UNSW Australia), Sydney, Australia

[4 ]Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, IR Iran

[5 ]Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, IR Iran

[6 ]Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, IR Iran

[7 ]Iranian Research Center for HIV/AIDS (IRCHA), Tehran University of Medical Sciences, Tehran, IR Iran

[8 ]Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran

[9 ]Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, IR Iran

[10 ]Department of Infectious Diseases and Tropical Medicine, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran

[11 ]Department of Gastroenterology and Hepatology, Isfahan University of Medical Sciences, Isfahan, IR Iran

[12 ]Hepatitis Research Center, Birjand University of Medical Sciences, Birjand, IR Iran

[13 ]Student’s Research Committee, Baqiyatallah University of Medical Sciences, Tehran, IR Iran

[14 ]Department of Medicine, Gastroenterology Division 1, AM and A Migliavacca Center for the Study of Liver Disease, Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Italy

[15 ]New York Associates in Gastroenterology, Bronx, New York, USA

[16 ]Division of Infectious Diseases, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon

[17 ]Cleveland Clinic, Cleveland, OH, USA

[18 ]Gastroenterology and Hepatology Department, Gouin Hospital, Clichy, France

[19 ]Department of Hepatitis and AIDS, Pasteur Institute of Iran, Tehran, IR Iran

Author notes

[* ]Corresponding Author: Seyed Moayed Alavian, Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Baqiyatallah University of Medical Sciences, Tehran, IR Iran. Tel: +98-2181264070, E-mail: alavian@ 123456thc.ir

Article

DOI: 10.5812/hepatmon.guideline

PMC ID: 5075356

SO-VID: 78677db4-baca-4f79-b807-1b463a178e05

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.

Recommendations for the Clinical Management of Hepatitis C in Iran: A Consensus-Based National Guideline

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Abstract

Context

Evidence Acquisition

Results

Conclusions

Related collections

Point-Of-Care Testing for Hepatitis

Most cited references 67

EASL Recommendations on Treatment of Hepatitis C 2015.

Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.

Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.

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