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.
This is a preview of subscription content, access via your institution.

Change history
20 May 2022
Editor's Note: The Editor-in-Chief is currently investigating this article as concerns have been raised about the reporting of this clinical trial. Further editorial action will be taken as appropriate once the investigation into the concerns is complete and all parties have been given an opportunity to respond in full.
20 September 2022
This article has been retracted. Please see the Retraction Notice for more detail: https://doi.org/10.1007/s00705-022-05600-w
References
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):95–100
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 32:884–892
Khattab MA, Ferenci P, Hadziyannis SJ et al (2011) Management of hepatitis C virus genotype 4: recommendations of an international expert panel. J Hepatol 54:1250–1262
Kamal SM, Nasser IA (2008) Hepatitis C genotype 4: what we know and what we don’t yet know. Hepatology 47:1371–1383
Gower E, Estes C, Blach S et al (2014) Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol 61:45–57
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:e204
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 59:318–327
Kamal SM (2007) Improving outcome in patients with hepatitis C virus genotype 4. Am J Gastroenterol 102:2582–2588
Abdel-Razek W, Waked I (2015) Optimal therapy in genotype 4 chronic hepatitis C: finally cured? Liver Int 35(Suppl. 1):27–34
Cholongitas E, Papatheodoridis GV (2014) Sofosbuvir: a novel oral agent for chronic hepatitis C. Ann Gastroenterol. 27(4):331–337
AASLD/IDSA/IAS-USA (2014) Recommendations for testing, managing, and treating hepatitis C. http://hcvguidelines.org. Accessed 24 April 2014
Tran TT (2012) A review of standard and newer treatment strategies in hepatitis C. Am J Manag Care 18(14 Suppl):S340–S349
Bourlière M, Khaloun A, Wartelle-Bladou C et al (2012) Future treatment of patients with HCV cirrhosis. Liver Int 32(Suppl 1):113–119
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
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
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):266–274
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):1040–1046
Zeuzem S, Dusheiko GM, Salupere R et al (2014) Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 370:1993–2001
Afdhal N, Reddy KR, Nelson DR et al (2014) Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 370:1483–1493
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 57:974–984
European Association for the Study of the Liver diseases (2014) EASL recommendations on treatment of hepatitis C. J Hepatol 61:373–395
AASLD/IDSA HCV Guidance Panel (2015) Hepatitis C guidance: AASLD IDSA recommendations for testing, managing and treating adults infected with hepatitis C virus. Hepatology 62:932–954
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
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):581–585
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):e35339
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):697–698
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):1462–1470
Welker MW, Luhne S, Lange CM et al (2016) Lactic acidosis in patients with hepatitis C virus cirrhosis and combined ribavirin/sofosbuvir treatment. J Hepatol 64(4):790–799. doi:10.1016/j.jhep.2015.11.034
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Source of support
None.
Conflict of interest
All authors declared that they have no conflict of interest.
Additional information
Handling Editor: Michael Carpenter.
About this article
Cite this article
Abd-Elsalam, S., Sharaf-Eldin, M., Soliman, S. et al. 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. Arch Virol 163, 51–56 (2018). https://doi.org/10.1007/s00705-017-3573-0
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00705-017-3573-0