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Use of Sofosbuvir Based Regimen in Patients with End Stage Renal Disease and Chronic Hepatitis C. An Open label, Non-randomized, Single arm, Single Center Study from Pakistan

Rajesh Mandhwani, Farina M.Hanif, Ghulamullah Lail, Nasir Hassan Luck, Muhammad Ali Khalid, Muhammad Manzoor ul Haque
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Abstract

Introduction: With the advent of interferon-free direct-acting antiviral agents (DAAs), the treatment of chronic hepatitis C (CHC) has been revolutionized. Pakistan is among those countries where novel sofosbuvir (SOF) free antiviral agents are not available.  Thus, we aimed to determine the virological response and safety of SOF based DAAs in CHC patients on long-term haemodialysis.

Methods: This non-randomized, single-arm, enrolled all hemodialysis patients with chronic hepatitis C; who consented, were treated with SOF in combination either with interferon (IFN group) or daclatasavir (DAC group) and the virological response was assessed as per standard guidelines. Data was analyzed by SPSS version 20.00.

 

Results: Out of 133 patients, majority were males with mean age of 31.92 ± 9.88years. Majority of patients (50.3%) had genotype 1, while mix genotype was documented in 6 (4.4%) patients. Among these, 60 patients (45.1 %) received standard IFN, SOF and RBV (IFN group). Remaining patients (54.9 %) received SOF, DAC and RBV (DAC group). End of treatment and sustained virological response at 12 weeks post-treatment were achieved in 133 (100%) and 129 (97 %) patients, respectively. The adverse effects were anemia in 58 (43.6 %) patients and raised alanine transaminases was noted in 11 patients.

 

Conclusion: Sofosbuvir in combination with Interferon or daclatasavir is efficacious and effective treatment regimen for patients on maintenance hemodialysis, especially in resource poor countries.

Keywords

End stage renal disease, hepatitis C virus, interferon, anti-viral treatment response, sustained virological response

References

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DOI: https://doi.org/10.22037/ghfbb.v13i2.1856