Genotype 4 HCV is the most common genotype in Saudi Arabia and the Middle East. Management of genotype 4 HCV has shifted to interferon free regimens with high rates of sustained virological response (SVR12), especially with NS5B/NS5A inhibitor combinations such as sofosbuvir and ledipasvir (Sof-Led). The combination of sofosbuvir and another NS5A inhibitor, daclatasvir (Sof-Dac) has been recommended by the guidelines for the management of HCV genotypes 1-3. However, its use was extended to genotype 4 HCV based on extrapolating evidence. Our hypothesis is that the efficacy of Sof-Dac combination is as good as Sof-Led. It's a prospective, observational, non-inferiority, and comparative to historical control study for all patients who will receive the combination of Sof-Dac (Group 1) starting October 1^st, 2016 compared to patients who received the combination of Sof-Led (Group 2) from Jan 1^st, 2014 to Sep 30^th, 2016. Primary endpoint is the proportion of patients achieving SVR12. Secondary endpoint is the change in Child Turcotte Pugh (CTP) scores at week 12 after end of treatment. The study was designed to recruit 102 subjects from each group. A total of 63 patients in group 1 and 102 patients in group 2 were included so far. Out of the 63 patients in group1, 39 (62%) reached the time to evaluate SVR12 and were included in the analysis. For the primary endpoint, 38 (97.44%) patients achieved SVR12 in group 1 versus 98 (96.18%) in group 2 (p=0.68). For the secondary end point, the change in CTP score at 12 weeks after end of treatment was reported as follow: 29 (74.36%) patients had no change, 4 (10.26%) improved and 6 (15.38%) worsened scores in group 1 versus 83 (81.27%) no change, 16 (15.79%) improved and 3 (2.92%) worsened scores in group 2 (p=0.04). This is the largest cohort ever presented that compared generic Sofosbuvir in combination with branded Daclatasvir to Sof-Led in the treatment of genotype 4 HCV infected patients. Our interim analysis showed that Sof-Dac for 12 weeks was non-inferior to Sof-Led in achieving SVR12. Final results will be available in 6-months and should add more guidance to our preliminary findings.

CITATION INFORMATION: Joharji H., Al-Jedai A., Alkortas D., Ajlan A., Devol E., Ahmed M., Aba Al-Khail F., El-Siesy H., Al-Sebayel M., Al-Ashgar H., Al-Quaiz M., Alhomodi W., Aloubal A., Almohishir A. Efficacy of Generic Sofosbuvir and Branded Daclatasvir Compared to Sofosbuvir and Ledipasvir Combination in the Treatment of Genotype 4 Hepatitis C Virus Am J Transplant. 2017;17 (suppl 3).

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