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EASL 2016: Portugal's Roll-Out of Hepatitis C DAA Therapy Achieves Impressive Outcomes

Roll-out of hepatitis C therapy using direct-acting antivirals (DAAs) has achieved excellent outcomes in Portugal, data presented to the International Liver Congress in Barcelona shows. Overall, 96% of treated patients had a sustained virological response (SVR) to therapy, with a 100% response rate seen in some sub-groups. Treatment also worked well for people with liver cirrhosis and treatment response was unaffected by HIV coinfection, previous hepatitis C therapy, or older age.

[Produced in collaboration with infohep.org]

Standard therapy for genotype 1 hepatitis C virus (HCV) includes the DAAs sofosbuvir (Sovaldi) or sofosbuvir/ledipasvir (Harvoni). This therapy has been associated with excellent outcomes in randomized controlled trials, with over 90% of patients having a sustained virological response 12 weeks after the completion of treatment (SVR12).

In February 2015, Portugal initiated a policy granting universal access to hepatitis C therapy with sofosbuvir or sofosbuvir/ledipasvir. In the present study, investigators analyzed outcomes among people who received this therapy in the first year after its roll-out.

Approximately 5500 people started treatment and data were available for 1069 individuals who completed treatment and were assessed for SVR by the end of January 2016.

The patients had a mean age of 52 years, 70% were male, 77% had HCV genotype 1, 27% had HIV/HCV coinfection, and 66% had previously taken a course of hepatitis C therapy.

The vast majority (94%) of patients were treated with sofosbuvir/ledipasvir. The overall SVR rate was 94%. However, 100% response rates were seen in some sub-groups.

Response rates among people with cirrhosis varied between 84% and 94%, with the poorest SVR rate observed in people with HCV genotype 3 and the best in people with genotype 1.

Overall, people with genotype 1 were more than twice as likely to achieve SVR compared to people with other HCV genotypes (OR 2.6). Cirrhosis was associated with an 80% reduction in the chance of achieving SVR (OR 0.2).

HIV/HCV coinfection (97% SVR rate), age, and previous hepatitis C treatment history did not have a significant impact on treatment outcomes.

The results underlined that people with HCV genotype 3 and cirrhosis -- a historically difficult-to-treat population -- had poorer outcomes than other sub-groups of patients.

“Real-life data demonstrates that hepatitis C treatment with universal access to [sofosbuvir/ledipasvir] and sofosbuvir-based regimens is associated with very high SVR rates, irrespective of HCV genotype involved," concluded the researchers.

4/27/16

Reference

R Tato-Marinho, J Rodrigues, JC Martins, et al. Evidence of impressive real-world SVR from Portuguese ledipasvir/sofosbuvir and sofosbuvir universal coverage program to eradicate (eliminate) hepatitis C. International Liver Congress 2016. Barcelona, April 13-17, 2016. Abstract LBP523.