Portugal's roll-out of HCV therapy with DAAs achieves impressive results

Roll-out of hepatitis C virus (HCV) 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 patients had a sustained virological response (SVR) to therapy with a 100% response seen in some sub-sets. Treatment also worked well for people with cirrhosis, achieving SVR rates of between 84 and 94%. Treatment response was unaffected by HIV co-infection, previous HCV therapy or older age.

Standard therapy for HCV is based on the DAAs ledipasvir/sofosbuvir (LDV/SOF) or sofosbuvir (SOF). This therapy has been associated with excellent outcomes in randomised controlled trials, with over 90% of patients having a sustained virological response to therapy twelve weeks after the completion of treatment (SVR12).

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

Approximately 5500 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 co-infection and 66% had previously taken a course of HCV therapy.

The vast majority (94%) of patients were treated with ledipasvir/sofosbuvir. The overall SVR rate (SVR12 or SVR24) was 94%. However, 100% response rates were seen in some sub-sets.

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

Overall, people with genotype 1 were more than two-times more likely to achieve SVR compared to people with other HCV genotypes (OR = 2.6; 95% CI, 1.4-5.0; p = 0.003). Cirrhosis was associated with an 80% reduction in the chance of achieving SVR (OR = 0.2; 95% CI, 0.1-0.4; p < 0.001).

HIV co-infection (97% SVR rate), age and previous HCV treatment history did not have a significant impact on treatment outcomes.

The results underlined that patients with 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 LDV/SOF and SOF-based regimens is associated with very high SVR rates, irrespective of HCV genotype involved,” conclude the researchers.

Tato Marinho R 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, Barcelona, 2016.