Efficacy and safety of sofosbuvir plus ribavirin in treatment-naive chronic hepatitis c genotype 3 patients of South Punjab, Pakistan

Authors

  • Qazi Masroor Ali Department of Medicine, Quaid e Azam Medical College, Bahawal Victoria Hospital, Bahawalpur, Pakistan
  • Syed Hashim Raza Department of Medicine, Quaid e Azam Medical College, Bahawal Victoria Hospital, Bahawalpur, Pakistan
  • Ali Imran Department of Medicine, Quaid e Azam Medical College, Bahawal Victoria Hospital, Bahawalpur, Pakistan
  • Saba Anjum Department of Medicine, Quaid e Azam Medical College, Bahawal Victoria Hospital, Bahawalpur, Pakistan
  • Maria Masroor Department of Pathology, Sheikh Zayed Medical College and Hospital, Rahim Yar Khan, Pakistan

DOI:

https://doi.org/10.18203/2320-6012.ijrms20205297

Keywords:

Efficacy, Hepatitis C virus infection, Sofosbuvir, Ribavirin, PCR

Abstract

Background: To evaluate the efficacy and safety of sofosbuvir (SOF) plus ribavirin (RIB) in naive patients with chronic HCV genotype 3. The study design was open label, quasi experimental study. The study was conducted at Medical Outpatient Department of Medical Unit-1, Bahawal Victoria Hospital, affiliated with Quaid e Azam Medical College (QAMC), Bahawalpur, from April 2016 to June 2019.

Methods: A total of 627 treatment-naive patients, aged above 18 years, with chronic Hepatitis C virus (HCV) genotype 3 infection were enrolled. SOF as 400 mg once a day plus weight-based RIB (1000 mg/day <75 kg and 1200 mg/day >75 kg) was given to all the study participants for 24 weeks. Qualitative polymerase chain reaction (PCR) for HCV ribonucleic acid (RNA) were done at 4 weeks to note the rapid virological response (RVR) whereas end of treatment response (ETR) was recorded at 24 weeks and sustained virological response (SVR) was noted 3 months after completion of treatment.

Results: By 4th week, PCR of 524 (83.6%) patients was available, out of which, 492 (93.9%) had undetectable HCV RNA. By the end of treatment (24 weeks), PCR of 401 (64.0%) patients was available, out of which, 393 (98.0%) had undetectable HCV RNA. Data of 291 (46.4%) patients was available for SVR, 274 (94.1%) had undetectable HCV RNA. Weakness and fatigue turned out to be the commonest side effects, observed in 236 (37.6%) patients.

Conclusions: Sofosbuvir was found to have good efficacy and safety in the local population of South Punjab having treatment-naïve chronic HCV genotype 3 infection.

References

Butt N, Reema S, Khan MA, Abbasi A, Butt S, Masood. MK, et al. Efficacy and Safety of Sofosbuvir and Ribavirin for Treating Chronic Hepatitis C, Genotype 3: Experience of a Tertiary Care Hospital at Karachi, Pakistan. Cureus. 2019;11(4):e44-58.

Lavanchy D. The global burden of hepatitis C. Liver International. 2009;1:74-81.

Gower E, Estes C, Blach S, Shearer KR, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014;61(1):45-57.

Akhter TS, Umar M, Khaar H, Aslam F, Nisar G, Naseer A, et al. Sofosbuvir For The Treatment Of Hepatitis C Genotype 3 Infected Patients In Pakistan. J Ayub Med Coll. 2016;28(4):884-9.

Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatol. 2009;49(4):1335-74.

Falck-Ytter Y, Kale H, Mullen KD, Sarbah SA, Sorescu L, McCullough AJ. Surprisingly small effect of antiviral treatment in patients with hepatitis C. Ann Intern Med. 2002;136(4):288-92.

Fried MW. Side effects of therapy of hepatitis C and their management. Hepatol. 2002:36(5):S237-44.

Osinusi A, Meissner EG, Lee YJ, Bon D, Heytens L, Nelson A, et al. Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients With Unfavorable Treatment Characteristics-A Randomized Clinical Trial. JAMA. 2013;310(8):804-11.

Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, et al. Nucleotide Polymerase Inhibitor Sofosbuvir plus Ribavirin for Hepatitis C. N Engl J Med. 2013;368(1):34-44.

Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland R, et al. Sofosbuvir + ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial. Hepatol. 2013;58(4):733-4.

Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, et al. Sofosbuvir for previously untreated chronic hepatitis C infection . N Engl J Med. 2013;368(20):1878-87.

Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013;368(20):1867-77.

Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatol. 2015;61(4):1127-35.

Foster GR, Pianko S, Brown A, Forton D, Nahass RG, George J, et al. 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. Gastroenterol. 2015;149(6):1462-70.

Mangia A, Piazzolla V. Overall efficacy and safety results of sofosbuvir-based therapies in Phase II and III studies. Dig Liver Dis. 2014;46(5):S179-85.

Farooqi JI, Humayun M, Chaudhry A, Sadik M, Din Z, Alam A, et al. Multi-center experience using Sofosbuvir & Ribavirin with and without pegylated interferon to treat hepatitis C patients with and without liver cirrhosis (RESiP Study: Real-life Experience with Sofosbuvir in Pakistan).

Sarwar S, Khan AA. Sofosbuvir based therapy in Hepatitis C patients with and without cirrhosis: Is there difference? Pak J Med Sci. 2017;33(1):37-41.

Azam Z, Shoaib M, Javed M, Sarwarm MA, Shaikh H, Khokhar N. Initial results of efficacy and safety of Sofosbuvir among Pakistani Population: A real life trial - Hepatitis Eradication Accuracy Trial of Sofosbuvir (HEATS). Pak J Med Sci. 2017;33(1):48-52.

Ziauddin, Khattak BM, Iqbal N, Inyatullah, Mahmood K, Zia S. Experience with sofosbuvir in treating HCV infected patients in tertiary care hospital khyber pakhtunkhwa. KJMS. 2017;10(3):415-19.

Nabi GT, Shakil A, Hussain SM, Mumtaz A, Nazeer UH, Yasir A et al. Clinical response of sofosbuvir (generic, searle) based treatment of chronic hepatitis c infection: a pakistani real life study home (hepatitis observational management envision) study. EJPMR. 2018;5(1):104-7.

Aziz H, Gil ML, Waheed Y, Adeeb U, Raza A, Bilal I, et al. Evaluation of prognostic factors for peg interferon alfa-2b plus ribavirin treatment on HCV infected patients in Pakistan. Infect Genet Evol. 2011;11(3):640-5.

Umar M, Khaar HU, Khan SA, Ahmed M, Ambreen S, Minhas ZM, et al. Early predictability of virological response in patients of chronic hepatitis- C with genotype-3, treated with pegylated interferon and ribavirin. J Ayub Med Coll. 2014;26(4):559-63.

Qureshi MS, Iqbal M, Nomani AZ, Rasheed K. Time for Change: Conventional Interferon Regimes Should Not Be the Standard of Care for Management of Pakistani Genotype-3 in Chronic Hepatitis C. J Coll Physicians Surg Pak. 2014;24(1):70-2.

Fateen F, Yousaf MN, Khan N, Nouman F, Iqbal W, Siraj S. Therapy success rate with pegylated interferon/ribavirin treatment of relapse and nonresponder hepatitis c patients. Adv Basic Med Sci. 2015;1(1):11-5.

Reddy R, Lim JK, Kuo A, Di Bisceglie A, Vargas H, Galati J, et al. All oral HCV therapy is safe and effective in patients with decompensated cirrhosis: report from HCV-TARGET. J Hepatol. 2015;62(2):S193.

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Published

2020-11-27

How to Cite

Ali, Q. M., Raza, S. H., Imran, A., Anjum, S., & Masroor, M. (2020). Efficacy and safety of sofosbuvir plus ribavirin in treatment-naive chronic hepatitis c genotype 3 patients of South Punjab, Pakistan. International Journal of Research in Medical Sciences, 8(12), 4242–4246. https://doi.org/10.18203/2320-6012.ijrms20205297

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Original Research Articles