Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir (SOF/LDV) ± Ribavirin (RBV) in Patients (n=130) Infected with HCV Genotype 6 (Real World Myanmar Experience)

Authors

  • Soe Thiha Maung Department of Hepatology, Yangon GI and Liver Centre
  • Aung Hlaing Bwa Department of Hepatology, Yangon GI and Liver Centre
  • Si Thu Sein Win Department of Hepatology, Yangon GI and Liver Centre
  • Su Su Htar Department of Hepatology, Yangon GI and Liver Centre
  • Khin Aye Wint Han Department of Hepatology, Yangon GI and Liver Centre
  • Moe Pwint Oo Department of Hepatology, Yangon GI and Liver Centre
  • Su Htar Lwin Department of Hepatology, Mandalay General Hospital
  • Naomi Khaing Than Hlaing Department of Hepatology, Yangon GI and Liver Centre
  • Khin Maung Win Department of Hepatology, Yangon GI and Liver Centre

Keywords:

Hepatitis C virus, genotype 6, sofosbuvir, ledipasvir, ribavirin

Abstract

Background: The prevalence rate of HCV Genotype 6 is estimated to account for 36% of all HCV infections in Myanmar.

Objective: This study is aimed to assess the efficacy of SOF/LDV ± RBV in patients infected with HCV genotype 6.

Methods: We performed the prospective and observational study of 130 patients infected with chronic HCV genotype 6 (both treatment-naïve and treatment-experienced) was performed. The patients were treated with SOF/LDV ± RBV for 12 or 24 weeks.

Results: Overall SVR (sustained virologic response) rate was 77% of patients. Higher SVR rate was noted among the cirrhotic patients (p-value = 0.003) and treatment-experienced patients (p-value = 0.008). Co-infection with HBV was seen in 7 patients and all these patients achieved SVR12. In the study cohort, 104 patients were treatment-naïve and 26 patients were treatment-experienced. SVR rates of treatment-naïve patients with or without cirrhosis treated with SOF/LDV regimen for 12 weeks was 65% (n=47), SOF/LDV/RBV for 12 weeks was 82% (n=9) and SOF/LDV for 24 weeks was 91% (n=19). Twenty-six treatment-experienced patients were treated with SOF/LDV/RBV for 24 weeks and achieved 96% SVR rate.

Conclusion: SOF/LDV ± RBV therapy achieved SVR12 in 77% of all categories of genotype 6 patients demonstrating the unsatisfactory response and efficacy in the era of SVR rates approaching 100% in other genotypes. Therefore, our real-life experience showed genotype 6 as the most difficult to treat genotype. However, it was noted that the addition of RBV or extension of treatment duration can increase the SVR rates significantly.

References

Hepatitis C Fact Sheets. Geneva: World Health Organization, October 2017 http://www.who.int/news-room/factsheets/detail/hepatitis-c

Chao DT, Abe K, Nguyen MH. Systematic review: epidemiology of hepatitis C genotype 6 and its management. Aliment Pharmacol Ther. 2011; 34: 286-96.

Lwin AA, Shinji T, Khin M, Win N, Obika M, Okada S, Koide N. Hepatitis C virus genotype distribution in Myanmar: Predominance of genotype 6 and existence of new genotype 6 subtype. Hepatol Res. 2007; 37:337–45.

Omata M, Kanda T, Wei L, Yu ML, Chuang WL, Ibrahim A, Lesmana CR, Sollano J, Kumar M, Jindal A, Sharma BC, Hamid SS, Dokmeci AK, Mamun-Al-Mahtab, McCaughan GW, Wasim J, Crawford DH, Kao JH, Yokosuka O, Lau GK, Sarin SK. APASL consensus statements and recommendation on treatment of hepatitis C Hepatol Int. 2016 Sep; 10 (5):702-26. doi: 10.1007/s12072-016-9717-6. Epub 2016 Apr 29

European Association for the Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2016 J Hepatol 2017; 2017(66):153-94

American Association for the Study of Liver Disease and the Infectious Diseases Society of America. Recommendations for Testing, Managing and Treating Hepatitis C July 2016

Gane EJ, Hyland RH, An D, et al. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology 2015; 149 (6): 1454-61 e1

Thu PT, Bunchorntavakul C, Tan HD, Palecki J, Reddy KR. Sofosbuvir-ledipasvir with or without ribavirin for chronic hepatitis C genotype-1 and 6: real-world experience in Vietnam. Antiviral therapy. 2018 Jan

Cavalcante LN, Lyra AC. Predictive factors associated with hepatitis C antiviral therapy response. World J Hepatol. 2015;7: 1617-31

Kutala BK, Mouri F, Castelnau C, et al. Efficacy and safety of sofosbuvir-based therapies in patients with advanced liver disease in a real-life cohort. Hepatol Med 2017; 9: 67-73

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Published

2021-01-01

How to Cite

Maung, S. T., Bwa, A. H., Sein Win, S. T., Htar, S. S., Wint Han, K. A., Pwint Oo, M., Lwin, S. H., Than Hlaing, N. K., & Win, K. M. (2021). Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir (SOF/LDV) ± Ribavirin (RBV) in Patients (n=130) Infected with HCV Genotype 6 (Real World Myanmar Experience). Greater Mekong Subregion Medical Journal, 1(1), 1–10. Retrieved from https://he02.tci-thaijo.org/index.php/gmsmj/article/view/247611

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Original article