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Abstract
Introduction There 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.
Methods Local 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.
Results In 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.
The 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.
Conclusion There 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 patients with cirrhosis, our guideline has been adapted to using alternative therapies as first line in patients with Genotype 3 infection and cirrhosis. We keep our guidelines for the treatment of patients without cirrhosis under review while awaiting analysis of the full dataset and further drug developments
Disclosure of Interest None Declared