Introduction Studies have identified groups of patients with Genotype 1 HCV infection who may achieve greater than 90% SVR 12 with only 8 weeks of treatment with Sofosbuvir/Ledipasvir (Sof/Led) (ION3 1). Patients in clinical trials tend to be highly selected and therefore our aim was to explore if the SVRs that can be achieved by this shortened duration of treatment in a ‘real life’ setting match the experience in the trials.
Methods Our local guidelines state that Genotype 1, non cirrhotic, treatment naive patients should receive 8 weeks of Sof/Led with the addition of Ribavirin if the viral load is >10 million iu/ml. Data on all patients commenced on Sof/Led between January and November 2015 was collected prospectively. Cirrhosis was defined as a fibroscan >12.5 kpa.
Results In total 42 patients have received treatment with Sof/Led for 8 weeks. Of the 42 patients 26 (62%) were male. The average age was 43 years (range 18–78). Average fibroscan score was 5.6 kpa (range 2.9–10.2). There were 4 patients with a fibroscan >9 (classified as F3). All were treatment naive. Opiate substitution therapy was prescribed in 6/42 (14%). The viral load distribution was <10,000 iu/ml – 5/42 (12%), 10001 iu/ml – <10 M iu/ml –34/42 (81%), >10 M–3/42 (7%).
To date all patients have completed treatment (100%). Table 1 outlines the end of treatment (EOT), Week 4 SVR (SVR 4) and Week 12 SVR (SVR 12) data.
The 2 patients ‘unknown’ were lost to follow up they completed treatment but did not attend for post treatment bloods. SVR 12 data will be available for all patients at the time of presentation.
Conclusion Treatment with 8 weeks of Sofosbuvir/Ledipasvir ± ribavirin is well tolerated with few side effects or premature treatment discontinuations. Our data suggest that the SVRs rates with shortened duration of therapy achieved in clinical trials are achievable in ‘real life’ settings.
Reference 1 Kowdley KV, et al, Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis. N Engl J Med. 2014 May 15;370(20):1879–88. doi: 10.1056/NEJMoa1402355. Epub 2014 Apr 10.
Disclosure of Interest None Declared
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