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Efficacy and safety of generic daclatasvir + sofosbuvir ± ribavirin in treatment of genotype 3 infected hepatitis C patients - a real life experience from Pakistan

Aim: Genotype 3 is the most prevalent genotype in Pakistan. Despite a revolution in the treatment of Hepatitis C, genotype 3 is still thought to be difficult to treat genotype. The price of patent direct acting antivirals was thought to a great limiting factor especially for low income countries. In Pakistan low cost generics of daclatasvir and sofosbuvir are easily available for treatment. The aim of our study is to provide real life local data to determine their efficacy and safety. Methods: This open-label, non-randomized, uncontrolled study was carried out at Center for Liver and Digestive Diseases, Holyfamily Hospital, Rawalpindi. We enrolled patients from March 2016 through March 2018 who were 18 years or older having chronic hepatitis C infection with detectable polymerase chain reaction (PCR), regardless of whether they were treatment naïve or have experienced Interferon in the past. The patients were offered generic sofosbuvir 400 mg and daclatasvir 60 mg once daily with or without ribavirin for a period of 12 to 24 weeks. Followup PCRs were performed at 4th week of treatment, end of treatment and 12 weeks post treatment. All those patients were included in the study that had at least one follow-up PCR during or after the course of treatment. Results: A total of 102 patients were enrolled in the study with a mean age of 48.11 ± 12.70 including 63% males and 37% females. All patients were genotype 3. On 4th week follow up, 31/36 (86.11%) patients had quantitative PCR negative. Out of 102 patients 78 patients had follow up PCR at the completion of therapy with an end of treatment response of about 96.1%. Thirty patients had a follow up at 12 weeks post treatment with a SVR12 of 83.33% (25/30) amongst which treatment Naïve had a response rate of 84% (21/25), treatment experience 80% (4/5), non-cirrhotics 85.71% (12/14), cirrhotics 81.25% (13/16) and decompensated chronic liver disease patients have a SVR12 of about 83.33% (10/12) respectively. The combination was well tolerated with few side effects, 18.6% patients had itching, 10.8% had insomnia, 8.8% had oral ulcers and 6.9% had fatigue. Conclusion: Generic sofosbuvir and daclatasvir are cheap, safe and efficacious with a SVR12 of about 83.33% amongst genotype 3 patients. These generics will act as a pivot in the eradication of hepatitis C infection from developing world.