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.

Glossary

sustained virological response (SVR)

The continued, long-term suppression of a virus as a result of treatment. In hepatitis C, refers to undetectable hepatitis C RNA after treatment has come to an end. Usually SVR refers to RNA remaining undetectable for 12 or 24 weeks after ending treatment and is considered to be a cure (SVR12 or SVR24).

cirrhosis

Severe fibrosis, or scarring of organs. The structure of the organs is altered, and their function diminished. The term cirrhosis is often used in relation to the liver. 

antiviral

A drug that acts against a virus or viruses.

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.

References

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.