Sustained virological response (SVR) and safety of two direct acting anti-viral (DAA) combination therapies in Chronic Hepatitis-C infected patients of Lahore, Pakistan. A Randomized Controlled Trial

SVR and DAA Therapies in Hepatitis-C Infected Patients

Authors

  • Salman Kazmi Mayo hospital, Lahore, Pakistan
  • Humaira Farooqi Pathology Department, King Edward Medical University, Lahore, Pakistan
  • Umer Sohail Mayo hospital, Lahore, Pakistan
  • Sohaib Haider Zaidi Endocrinology Department, Services Hospital, Lahore, Pakistan
  • Naeem Majeed United Nations International Children's Emergency Fund (UNICEF), Lahore, Pakistan
  • Safia Firdus Faculty of Rehabilitation Sciences and Allied Health Sciences (FRAHS), Riphah International University, Lahore, Pakistan

DOI:

https://doi.org/10.54393/pjhs.v3i06.294

Keywords:

Chronic HCV, Direct Acting Anti-Virals (DAA), Sustained Virological Response (SVR), Sofobuvir

Abstract

Chronic Hepatitis C (HCV) is a deadly infection affecting > 185 million people worldwide and led to liver cirrhosis, hepatocellular carcinoma, or liver failure. Recently, treatment regimens of chronic HCV have entered the era of direct acting anti-virals (DAAs). Sustained virological response (SVR) rate is one of the best available tools to evaluate the efficacy of DAA treatments. Objective: To compare SVR rate and safety of two combinations of DAA treatments (Sofosbuvir and Daclatasvir vs Sofosbuvir and Velpatasvir) in chronic HCV infected patients of Lahore, Pakistan. Methods: Present randomized controlled trial was conducted at Mayo Hospital, Lahore, Pakistan and recruited 76 chronic HCV infected patients according to Consort guidelines. Registered patients were allocated in two groups by lottery method. Group A received sofobuvir with daclatasvir (SOFO + DCV) while group B received sofobuvir with velpatasvir (SOFO + VEL) treatment for 12 weeks. Response to therapy was evaluated in terms of SVR after 24 weeks and safety profile of the drug. Results: Both treatment groups showed high SVR 24 weeks after the completion of therapy. Group A (SOFO + DCV) presented 92% SVR while group B showed 97% SVR rate. Both DAA combination therapies presented good efficacy and safety profile. Few contraindications noted during the treatment included fatigue, arthritis, headache, loss of appetite and anemia. Conclusions: The efficacy of both DAA combination therapies was comparably high with > 90% SVR rate. Group A proved safer as compared to group B. Studied DAA combinations are effective treatment options for chronic HCV treatment planning.

References

Petruzziello A, Marigliano S, Loquercio G, Cozzolino A, Cacciapuoti C. Global epidemiology of hepatitis C virus infection: An up-date of the distribution and circulation of hepatitis C virus genotypes. World Journal of Gastroenterology. 2016 Sep; 22(34):7824. doi: 10.3748%2Fwjg.v22.i34.7824

Smith-Palmer J, Cerri K, Valentine W. Achieving sustained virologic response in hepatitis C: a systematic review of the clinical, economic and quality of life benefits. BMC Infectious Diseases. 2015 Dec; 15(1):1-9. doi: 10.1186/s12879-015-0748-8

Lauer GM and Walker BD. Hepatitis C virus infection. New England Journal of Medicine. 2001 Jul; 345(1):41-52. doi: 10.1056/NEJM200107053450107

Jacobson IM, Dore GJ, Foster GR, Fried MW, Radu M, Rafalsky VV, et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. The Lancet. 2014 Aug; 384(9941):403-13. doi: 10.1016/S0140-6736(14)60494-3

Manns M, Marcellin P, Poordad F, De Araujo ES, Buti M, Horsmans Y, et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet. 2014 Aug; 384(9941):414-26. doi: 10.1016/S0140-6736(14)60538-9

Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, DeMicco M, et al. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. The Lancet. 2013 Jun; 381(9883):2100-7. doi: 10.1016/S0140-6736(13)60247-0

Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. New England Journal of Medicine. 2013 May; 368(20):1878-87. doi: 10.1056/NEJMoa1214853

Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. New England Journal of Medicine. 2014 May; 370(20):1889-98. doi: 10.1056/NEJMoa1402454

Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. New England Journal of Medicine. 2014 Apr; 370(16):1483-93. doi: 10.1056/NEJMoa1316366

Pearlman BL and Traub N. Sustained virologic response to antiviral therapy for chronic hepatitis C virus infection: a cure and so much more. Clinical Infectious Diseases. 2011 Apr; 52(7):889-900. doi: 10.1093/cid/cir076

Martinot‐Peignoux M, Stern C, Maylin S, Ripault MP, Boyer N, Leclere L, et al. Twelve weeks posttreatment follow‐up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin. Hepatology. 2010 Apr; 51(4):1122-6. doi: 10.1002/hep.23444

Campos-Varela I, Castells L, Esteban JI, Bes M, Rodríguez-Frías F, Sapisochin G, et al. Twelve-week posttreatment follow-up to predict sustained virologic response for recurrent hepatitis C infection in liver recipients. Transplantation. 2012 Feb; 93(4):450-3. doi: 10.1097/TP.0b013e318240e9dd

Chen J, Florian J, Carter W, Fleischer RD, Hammerstrom TS, Jadhav PR, et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology. 2013 Jun; 144(7):1450-5. doi: 10.1053/j.gastro.2013.02.039

Spengler U. Direct antiviral agents (DAAs)-A new age in the treatment of hepatitis C virus infection. Pharmacology and Therapeutics. 2018 Mar; 183:118-26. doi: 10.1016/j.pharmthera.2017.10.009

Hill A, Simmons B, Gotham D, Fortunak J. Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C. Journal of Virus Eradication. 2016 Jan; 2(1):28-40. doi: 10.1016/S2055-6640(20)30691-9

European Association for The Study of The Liver. EASL recommendations on treatment of hepatitis C 2016. Journal of Hepatology. 2017 Jan; 66(1):153-94. doi: 10.1016/j.jhep.2016.09.001

Chung RT, Ghany MG, Kim AY, Marks KM, Naggie S, Vargas HE, et al. Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clinical Infectious Disease. 2018 Sep; 67(10):1477–92. doi: 10.1093/cid/ciy585

Falade-Nwulia O, Suarez-Cuervo C, Nelson DR, Fried MW, Segal JB, Sulkowski MS. Oral direct-acting agent therapy for hepatitis C virus infection: a systematic review. Annals of Internal Medicine. 2017 May; 166(9):637-48. doi: 10.7326/M16-2575

Belperio PS, Shahoumian TA, Loomis TP, Mole LA, Backus LI. Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3. Journal of Hepatology. 2019 Jan; 70(1):15-23. doi: 10.1016/j.jhep.2018.09.018

Omar H, El Akel W, Elbaz T, El Kassas M, Elsaeed K, El Shazly H, et al. Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real‐world results from 18 378 patients in Egypt. Alimentary Pharmacology and Therapeutics. 2018 Feb; 47(3):421-31. doi: 10.1111/apt.14628

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Published

2022-11-30
CITATION
DOI: 10.54393/pjhs.v3i06.294
Published: 2022-11-30

How to Cite

Kazmi, S. ., Farooqi, H. ., Sohail, U. ., Haider Zaidi, S. ., Majeed, N., & Firdus, S. . (2022). Sustained virological response (SVR) and safety of two direct acting anti-viral (DAA) combination therapies in Chronic Hepatitis-C infected patients of Lahore, Pakistan. A Randomized Controlled Trial: SVR and DAA Therapies in Hepatitis-C Infected Patients . Pakistan Journal of Health Sciences, 3(06), 135–139. https://doi.org/10.54393/pjhs.v3i06.294

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