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01-01-2018 | Original Article

RETRACTED ARTICLE: Efficacy and safety of sofosbuvir plus ribavirin for treatment of cirrhotic patients with genotype 4 hepatitis C virus in real-life clinical practice

Authors: Sherief Abd-Elsalam, Mohamed Sharaf-Eldin, Shaimaa Soliman, Asem Elfert, Rehab Badawi, Youssef K. Ahmad

Published in: Archives of Virology | Issue 1/2018

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Abstract

Egypt has the highest hepatitis C virus (HCV) prevalence in the world. Sofosbuvir is a new highly effective drug for treatment of HCV infection. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to fourfold reduced duration of therapy. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin in Egyptian patients with liver cirrhosis due to chronic HCV infection. We studied 2400 cirrhotic Egyptian patients with chronic HCV infection who were treated with dual therapy with sofosbuvir and ribavirin for 24 weeks. Efficacy was determined by assessment of serum HCV RNA. Any adverse events during treatment were recorded. Two thousand four hundred cirrhotic Egyptian patients with chronic HCV infection treated with sofosbuvir and ribavirin for 24 weeks were enrolled in the study. The mean age of the studied group (± SD) was 53.9 ± 6.5 years, 1549 (64.54%) were males, all were cirrhotic patients, 3.41% were treatment-experienced, the baseline mean HCV RNA concentration was 4.33 × 106 IU/mL, and 94.37% of the patients had completed the full course of therapy. The overall SVR12 rate was 71.2%. The most common adverse events were fatigue, myalgia, headache, insomnia, and anemia. One hundred thirty-five (5.63%) patients stopped treatment permanently due to the appearance of complications that prevented continuation of treatment. The sofosbuvir and ribavirin combination is safe and effective in treatment of HCV patients with liver cirrhosis. However, further studies are needed to establish the optimal treatment regimen for those cases.
Literature
1.
go back to reference Ahmed OA, Kaisar HH, Hawash N et al (2017) Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in treatment of a cohort of Egyptian patients with hepatitis C virus infection. Infect Disord Drug Targets 17(2):95–100CrossRef Ahmed OA, Kaisar HH, Hawash N et al (2017) Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in treatment of a cohort of Egyptian patients with hepatitis C virus infection. Infect Disord Drug Targets 17(2):95–100CrossRef
2.
go back to reference McOmish F, Yap PL, Dow BC et al (1994) Geographical distribution of hepatitis C virus genotypes in blood donors: an international collaborative survey. J Clin Microbiol 32:884–892CrossRef McOmish F, Yap PL, Dow BC et al (1994) Geographical distribution of hepatitis C virus genotypes in blood donors: an international collaborative survey. J Clin Microbiol 32:884–892CrossRef
3.
go back to reference Khattab MA, Ferenci P, Hadziyannis SJ et al (2011) Management of hepatitis C virus genotype 4: recommendations of an international expert panel. J Hepatol 54:1250–1262CrossRef Khattab MA, Ferenci P, Hadziyannis SJ et al (2011) Management of hepatitis C virus genotype 4: recommendations of an international expert panel. J Hepatol 54:1250–1262CrossRef
4.
go back to reference Kamal SM, Nasser IA (2008) Hepatitis C genotype 4: what we know and what we don’t yet know. Hepatology 47:1371–1383CrossRef Kamal SM, Nasser IA (2008) Hepatitis C genotype 4: what we know and what we don’t yet know. Hepatology 47:1371–1383CrossRef
5.
go back to reference Gower E, Estes C, Blach S et al (2014) Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol 61:45–57CrossRef Gower E, Estes C, Blach S et al (2014) Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol 61:45–57CrossRef
6.
go back to reference AbdElrazek AE, Bilasy SE, Elbanna AE et al (2014) Prior to the oral therapy, what do we know about HCV-4 in Egypt: a randomized survey of prevalence and risks using data mining computed analysis. Medicine (Baltimore) 93:e204CrossRef AbdElrazek AE, Bilasy SE, Elbanna AE et al (2014) Prior to the oral therapy, what do we know about HCV-4 in Egypt: a randomized survey of prevalence and risks using data mining computed analysis. Medicine (Baltimore) 93:e204CrossRef
7.
go back to reference Smith DB, Bukh J, Kuiken C et al (2014) Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: updated criteria and genotype assignment Web resource. Hepatology 59:318–327CrossRef Smith DB, Bukh J, Kuiken C et al (2014) Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: updated criteria and genotype assignment Web resource. Hepatology 59:318–327CrossRef
8.
go back to reference Kamal SM (2007) Improving outcome in patients with hepatitis C virus genotype 4. Am J Gastroenterol 102:2582–2588CrossRef Kamal SM (2007) Improving outcome in patients with hepatitis C virus genotype 4. Am J Gastroenterol 102:2582–2588CrossRef
9.
go back to reference Abdel-Razek W, Waked I (2015) Optimal therapy in genotype 4 chronic hepatitis C: finally cured? Liver Int 35(Suppl. 1):27–34CrossRef Abdel-Razek W, Waked I (2015) Optimal therapy in genotype 4 chronic hepatitis C: finally cured? Liver Int 35(Suppl. 1):27–34CrossRef
10.
go back to reference Cholongitas E, Papatheodoridis GV (2014) Sofosbuvir: a novel oral agent for chronic hepatitis C. Ann Gastroenterol. 27(4):331–337PubMedPubMedCentral Cholongitas E, Papatheodoridis GV (2014) Sofosbuvir: a novel oral agent for chronic hepatitis C. Ann Gastroenterol. 27(4):331–337PubMedPubMedCentral
12.
go back to reference Tran TT (2012) A review of standard and newer treatment strategies in hepatitis C. Am J Manag Care 18(14 Suppl):S340–S349PubMed Tran TT (2012) A review of standard and newer treatment strategies in hepatitis C. Am J Manag Care 18(14 Suppl):S340–S349PubMed
13.
go back to reference Bourlière M, Khaloun A, Wartelle-Bladou C et al (2012) Future treatment of patients with HCV cirrhosis. Liver Int 32(Suppl 1):113–119CrossRef Bourlière M, Khaloun A, Wartelle-Bladou C et al (2012) Future treatment of patients with HCV cirrhosis. Liver Int 32(Suppl 1):113–119CrossRef
14.
go back to reference Manns M, Vierling JM, Bacon BR et al (2013) High sustained viral response at 12- and 24-week follow-up of MK-7152 with pegylated interferon alfa-2a and ribavirin in HCV genotype 1 treatment-naive non-cirrhotic patients. J Hepatol 58(Suppl N1):1 Manns M, Vierling JM, Bacon BR et al (2013) High sustained viral response at 12- and 24-week follow-up of MK-7152 with pegylated interferon alfa-2a and ribavirin in HCV genotype 1 treatment-naive non-cirrhotic patients. J Hepatol 58(Suppl N1):1
15.
go back to reference Lawitz E, Gane E, Lalezari J et al (2013) High concordance of SVR4, SVR12, SVR24 in patients with HCV infection who have received treatment with sofosbuvir. The International Liver Congress, Amsterdam, p P848 Lawitz E, Gane E, Lalezari J et al (2013) High concordance of SVR4, SVR12, SVR24 in patients with HCV infection who have received treatment with sofosbuvir. The International Liver Congress, Amsterdam, p P848
16.
go back to reference Elwan N, Elfert A, Abd-Elsalam S et al (2016) Study of hepatic steatosis index in patients with chronic HCV infection. Int J Curr Microbiol App Sci 5(5):266–274CrossRef Elwan N, Elfert A, Abd-Elsalam S et al (2016) Study of hepatic steatosis index in patients with chronic HCV infection. Int J Curr Microbiol App Sci 5(5):266–274CrossRef
17.
go back to reference Ruane PJ, Ain D, Stryker R et al (2015) Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry. J Hepatol 62(5):1040–1046CrossRef Ruane PJ, Ain D, Stryker R et al (2015) Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry. J Hepatol 62(5):1040–1046CrossRef
18.
go back to reference Zeuzem S, Dusheiko GM, Salupere R et al (2014) Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 370:1993–2001CrossRef Zeuzem S, Dusheiko GM, Salupere R et al (2014) Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 370:1993–2001CrossRef
19.
go back to reference Afdhal N, Reddy KR, Nelson DR et al (2014) Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 370:1483–1493CrossRef Afdhal N, Reddy KR, Nelson DR et al (2014) Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 370:1483–1493CrossRef
20.
go back to reference Sulkowski MS, Poordad F, Manns MP et al (2013) Anemia during treatment with peg interferon alfa-2b/ribavirin and boceprevir: Analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial. Hepatology 57:974–984CrossRef Sulkowski MS, Poordad F, Manns MP et al (2013) Anemia during treatment with peg interferon alfa-2b/ribavirin and boceprevir: Analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial. Hepatology 57:974–984CrossRef
21.
go back to reference European Association for the Study of the Liver diseases (2014) EASL recommendations on treatment of hepatitis C. J Hepatol 61:373–395CrossRef European Association for the Study of the Liver diseases (2014) EASL recommendations on treatment of hepatitis C. J Hepatol 61:373–395CrossRef
22.
go back to reference AASLD/IDSA HCV Guidance Panel (2015) Hepatitis C guidance: AASLD IDSA recommendations for testing, managing and treating adults infected with hepatitis C virus. Hepatology 62:932–954CrossRef AASLD/IDSA HCV Guidance Panel (2015) Hepatitis C guidance: AASLD IDSA recommendations for testing, managing and treating adults infected with hepatitis C virus. Hepatology 62:932–954CrossRef
23.
go back to reference Esmat GE, Shiha G, Omar RF et al (2014) Sofosbuvir plus ribavirin in the treatment of Egyptian patients with chronic genotype 4 HCV. Hepatology 60(4 suppl):133A Esmat GE, Shiha G, Omar RF et al (2014) Sofosbuvir plus ribavirin in the treatment of Egyptian patients with chronic genotype 4 HCV. Hepatology 60(4 suppl):133A
24.
go back to reference Doss W, Shiha G, Hassany M et al (2015) Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol 63(3):581–585CrossRef Doss W, Shiha G, Hassany M et al (2015) Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol 63(3):581–585CrossRef
25.
go back to reference Dabbous HM, Montasser IF, Sakr MA et al (2016) Safety, efficacy, and tolerability of sofosbuvir and ribavirin in management of recurrent hepatitis C virus genotype 4 after living donor liver transplant in Egypt: What have we learned so far? Hepat Mon 16(5):e35339CrossRef Dabbous HM, Montasser IF, Sakr MA et al (2016) Safety, efficacy, and tolerability of sofosbuvir and ribavirin in management of recurrent hepatitis C virus genotype 4 after living donor liver transplant in Egypt: What have we learned so far? Hepat Mon 16(5):e35339CrossRef
26.
go back to reference Halfon P, Mohamed S, Penaranda G et al (2016) Hepatitis C genotype 4R resistance-associated polymorphisms: the achilles heel of the nonstructural 5A inhibitors? Hepatology 64(2):697–698CrossRef Halfon P, Mohamed S, Penaranda G et al (2016) Hepatitis C genotype 4R resistance-associated polymorphisms: the achilles heel of the nonstructural 5A inhibitors? Hepatology 64(2):697–698CrossRef
27.
go back to reference Foster GR, Pianko S, Brown A et al (2015) Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experienced patients with cirrhosis and hepatitis C virus genotype 2 infection. Gastroenterology 149(6):1462–1470CrossRef Foster GR, Pianko S, Brown A et al (2015) Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experienced patients with cirrhosis and hepatitis C virus genotype 2 infection. Gastroenterology 149(6):1462–1470CrossRef
Metadata
Title
RETRACTED ARTICLE: Efficacy and safety of sofosbuvir plus ribavirin for treatment of cirrhotic patients with genotype 4 hepatitis C virus in real-life clinical practice
Authors
Sherief Abd-Elsalam
Mohamed Sharaf-Eldin
Shaimaa Soliman
Asem Elfert
Rehab Badawi
Youssef K. Ahmad
Publication date
01-01-2018
Publisher
Springer Vienna
Published in
Archives of Virology / Issue 1/2018
Print ISSN: 0304-8608
Electronic ISSN: 1432-8798
DOI
https://doi.org/10.1007/s00705-017-3573-0

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