A Randomized study of sofosbuvir plus ribavirin with and without PEG interferon alpha 2b in treatment of hepatitis C genotype 3 infection: Real life data from a Tertiary Care Center

  • Anurag Tiwari
  • Gaurav Garg Associate Professor, Medicine Department, LLRM Medical College Meerut U.P.
  • Deepika Chaturvedi IMS BHU Varanasi U.P.
  • Alka Srivasatava LLRM Medical College Meerut U.P.
Keywords: Sofosbuvir, ETR, SVR12

Abstract

Background and Aim- Sofosbuvir, a polymerase inhibitor is pangenotypic directly acting antiviral for hepatitis C. In this study we evaluate two sofosbuvir containing regimens with or without pegylated interferon (PEGIFN) in patients with chronic hepatitis or compensated cirrhosis caused by hepatitis C genotype 3 infections.

Methods- It was a prospective, single centre, randomized open label study. Thirty nine patients were randomized into two groups: sofosbuvir plus ribavirin with (A) and without (B) PEGIFN alpha 2b for 12 and 24 weeks respectively. Patients with contraindications and treatment experience were excluded. Primary end points were end of treatment response (ETR) and sustained virological response at 12 weeks (SVR12). Rates of adverse effects were secondary end point.

Results- Baseline characteristics in both groups were comparable. Two patients in group B did not complete therapy and excluded from analysis. ETR and SVR12 rate in group A were 100 % and in group B were 89.4 % showing 100% concordance between ETR and SVR12 in either group. Non-specific adverse effects were more frequent in group A than group B (94.4 versus 79%). Rates of hemoglobin decrease, neutropenia and thrombocytopenia were 100, 17 and 44.4% in group A and 94, 0 and 15.8% in group B respectively.

Conclusion- Addition of PEGIFN to sofosbuvir and ribavirin achieves higher ETR and SVR12 and reduces duration of therapy. PEG-IFN based treatment leads to higher hematological as well as non hematological side effects but these are mild and easily manageable during 12 weeks treatment.

Downloads

Download data is not yet available.

Author Biographies

Anurag Tiwari
DM Gastroenterology Varanasi U.P.
Gaurav Garg, Associate Professor, Medicine Department, LLRM Medical College Meerut U.P.
Associate Professor, Medicine Department, LLRM Medical College Meerut U.P.
Deepika Chaturvedi, IMS BHU Varanasi U.P.
Post Graduate Resident Biochemistry Department, IMS BHU Varanasi
Alka Srivasatava, LLRM Medical College Meerut U.P.
Lecturer Physiology Department, LLRM Medical College Meerut U.P.

References

Hatzakis A, Chulanov V, Gadano AC, et al. The present and future disease burden of hepatitis C virus (HCV) infections with today's treatment paradigm – volume 2. J Viral Hepat. 2015;22(suppl. S1):26–45.

Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology.2015;61:77–87.

Gane EJ, Stedman CA, Hyland RH, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013;368:34–44.

Reyes-Mendez MA, Juarez-Figueroa L, Iracheta-Hernandez P, Medina-Islas Y, RuizGonzalez V. Comparison of two diagnostic algorithms for the identification of patients with HCV viremia using a new HCV antigen test. Ann Hepatol. 2014;13:337–342.

Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013;368:1867–1877.

Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013;368:1867–1877.

Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014;370:1993–2001.

Lawitz E, Lalezari JP, Hassanein T, et al. Sofosbuvir in combination with peginterferon alfa2a and ribavirin for non-cirrhotic, treatmentnaive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2013;13:401–408.

Lawitz E, Poordad F, Brainard DM, et al. Sofosbuvir in combination with PegIFN and ribavirin for 12 weeks provides high SVR rates in HCV-infected genotype 2 or 3 treatmentexperienced patients with and without compensated cirrhosis: results from the LONESTAR-2 study. Hepatology. 2013;58:1380 A.

Esteban R, Nyberg L, Lalezari J, et al. Successful retreatment with sofosbuvir-containing regimens for HCV genotype 2 or 3 infected patients who failed prior sofosbuvir plus ribavirin therapy. J Hepatol. 2014;60:S4.

Bourlière M, Khaloun A, Wartelle- Bladou C, et al. Chronic hepatitis C: treatments of the future. Clin Res Hepatol Gastroenterol 2011;35:Suppl 2:S84-S95.

Lam AM, Murakami E, Espiritu C, et al. PSI-7851, a pronucleotide of beta-D-2′- deoxy-2′fluoro-2′-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication. Antimicrob Agents Chemother 2010;54: 3187-96.

Sofia MJ, Bao D, Chang W, et al. Discovery of a β-d-2’-deoxy-2′-α-fluoro-2′-β- Cmethyluridine nucleotide prodrug (PSI- 7977) for the treatment of hepatitis C virus. J Med Chem 2010;53:7202-18.

Foster GR, Pianko S, Brown A, et al. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with HCV genotype 3 infection and treatment-experienced patients with cirrhosis and HCV genotype 2 infection. Gastroenterology. 2015. http://dx.doi.org/10.1053/j.gastro.2015.07.043.

Published
2018-04-01
Section
Original Research Articles