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Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in “real-life” cohort

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Abstract

Background

The safety and efficacy of sofosbuvir-based treatment (sofosbuvir and ribavirin with or without pegylated interferon-α) for hepatitis C virus (HCV) infection has been established in clinical trials. However, there is limited data regarding safety and efficacy of sofosbuvir-based treatment for HCV infection in a “real-life” cohort. We describe our experience with sofosbuvir-based treatment for HCV infection in a real-life cohort.

Methods

This was a prospective, nonrandomized and observational study at a tertiary care centre in Surat, India. The primary end-point was proportion of the study patients who achieved a sustained virological response 12 weeks after cessation of treatment (SVR 12). Secondary end-points of the study include SVR 4, virological relapse and appearance of adverse events.

Results

A total of 107 patients with chronic HCV who received sofosbuvir-based treatment were included in the study. During study period, two patients died due to severity of liver complications. Hence, overall rate of SVR 4 and SVR 12 was 98.1 % (n = 103/105) and 94.3 % (n = 99/105), respectively. Among 67 patients with HCV genotype-3 infection, the SVR 12 rate was 92.5 % (n = 62/67), and among 38 patients with HCV genotype-1 infection, the rate of SVR 12 was 97.4 % (n=37/38). A total of 32 (29.9 %) patients reported adverse events during the course of sofosbuvir-based treatment. None of the patient discontinued treatment due to adverse event.

Conclusions

Sofosbuvir-based treatment is safe and efficacious in clinical practice in Indian patients with HCV genotype-1 and genotype-3 infection.

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Authors and Affiliations

  1. Department of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India

    Rajiv Mehta, Mayank Kabrawala, Subhash Nandwani, Mrunal Shah & Vishwa Bhayani

  2. Department of Physiology, Government Medical College, Majuragate, Surat, 395 001, India

    Rini Tekriwal & Payal Nandaniya

Authors
  1. Rajiv Mehta
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  2. Mayank Kabrawala
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  3. Subhash Nandwani
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  4. Rini Tekriwal
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  5. Payal Nandaniya
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  6. Mrunal Shah
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  7. Vishwa Bhayani
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Corresponding author

Correspondence to Rajiv Mehta.

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Conflict of interest

RM, MK, SN, RT, PN, MS, and VB declare that they have no conflict of interest.

Ethical consideration

The Institutional Review Board has given approval. This study was conducted in accordance with the principles of the Declaration of Helsinki as revised in 2000.

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Mehta, R., Kabrawala, M., Nandwani, S. et al. Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in “real-life” cohort. Indian J Gastroenterol 35, 459–464 (2016). https://doi.org/10.1007/s12664-016-0713-5

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  • DOI: https://doi.org/10.1007/s12664-016-0713-5

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