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 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 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 people 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.