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DAAs achieve excellent outcomes in real-world settings
Michael Carter, 2016-04-21 07:20:00
Hepatitis C virus
(HCV) therapy with direct acting antivirals (DAAs) is as effective in real-world
settings as it was in clinical trials, according to US research presented to
the International Liver Congress in Barcelona last week. Investigators from the
Department of Veteran Affairs (VA) analysed outcomes in over 9000 patients
treated with DAA combinations. Outcomes were excellent, with two combinations
achieving cure rates of 93%, similar to those seen in randomised studies with
strict eligibility criteria and close follow-up.
The development of
DAAs has revolutionised HCV treatment and care. The aim of treatment is an
undetectable viral load twelve weeks after the completion of therapy, usually
called a sustained virological response (SVR12). Several DAA regimens have
performed well in clinical trials, achieving SVR12 rates of 90% or more.
However, there are limited data on the effectiveness of DAAs in routine care
settings and it is therefore unclear if the impressive results observed in
clinical trials can be replicated in the real world.
the VA therefore analysed the records of 9,604 people with hepatitis C who completed
therapy with a DAA combination and were followed until twelve weeks after the completion of treatment.
received one of three regimens:
- simeprevir/sofosbuvir (3,064)
- ledipasvir/sofosbuvir (5,524)
majority (96.3%) of patients were male, 65.1% were aged between 60
and 65 years and 75.4% had HCV genotype 1.
Patients with more
advanced liver disease at baseline were more likely to have received therapy
with simeprevir/sofosbuvir, the first of the study regimens to come to market.
combinations achieved impressive SVR12 rates.
- simeprevir/sofosbuvir = 87.3%
- ledipasvir/sofosbuvir = 93.2%
- 3D = 93.4%
for baseline characteristics, people taking ledipasvir/sofosbuvir and people taking the 3D combination were significantly more likely to
achieve SVR12 than people taking simeprevir/sofosbuvir. The severity of baseline liver disease affected
treatment outcomes, with more severe disease associated with lower chances of
achieving SVR12. Non-genotype 1 infection was also associated with reduced odds
of sustained viral suppression.
Encouragingly, co-infection with HIV did not affect treatment outcomes.
conclude that use of DAA combinations in routine settings have been found “to
fulfill their promise of greater than 90%, as first documented in randomized