PTH-109 Real Life Data on Sofosbuvir/Ledipasvir + Ribavirin for 12 Weeks in Genotype 3 Patients in The North East of Scotland

IntroductionThere are robust data from clinical trials supporting the use of the combination of Sofosbuvir and Ledipasvir (sof/ledip) in patients with Genotype 1 HCV infection with expected SVR rates of >90%. Data on the success rates of this combination for the treatment of patient with Genotype 3 infection are less robust. Our aim was to examine the SVR rates when using this combination in a “real life’ setting in patients with Genotype 3 infection.MethodsLocal guidelines from December 2014 to November 2015 advised the use of the combination of sof/ledip along with ribavirin for 12 weeks for patients with Genotype 3 HCV infection who were interferon intolerant or ineligible. During this period, data was collected prospectively on all patients commenced this regimen. Fibrosis F3 was defined as fibroscan >9 kPa, cirrhosis was defined as a fibroscan >12.5 kPa or confirmed on liver biopsy.ResultsIn total 26 patients with genotype 3 infection received treatment with sof/ledip plus ribavirin for 12 weeks. Of the 26 patients, 21 (81%) were male. The average age was 53 (range 38–68). Mean fibroscan score was 18.7 kPa (range 4.8–63.9). Table 1 describes the fibroscan score distribution.Abstract PTH-109 Table 112.5 kPaNumber of patients31814The majority (17/26) (65%) of patients were treatment naive. Opiate substitution therapy was prescribed in 5/26 (19%). SVR 4 data is available in 25 patients (22/25, 88%) and SVR 12 available in 21 patients (17/21, 81%). Figure 1 shows SVR data for those with and without cirrhosis, SVR was 100% in those without cirrhosis. One patient died of end stage liver disease at week 3 on treatment but all others have completed the prescribed course of treatment. One patient is HCV RNA negative at the end of treatment but not yet 4 weeks post treatment. The 3 patients who did not achieve SVR 12 were all cirrhotic with a history of hepatic decompensation, 2 treatment naive and 1 treatment experienced. Intention to treat analysis of SVR 12 for all patients will be available by the time of presentation.Abstract PTH-109 Figure 1ConclusionThere are limited options for all oral therapy to treat patients with Genotype 3 HCV infection. Our data demonstrates that the combination of sof/ledip with ribavirin is well tolerated with few side effects. All patients without cirrhosis completed the planned treatment regimen and obtained viral clearance. As a result of emerging data and our experience of a lower SVR rate in pati