Once-daily combination pills that can treat all genotypes of
hepatitis C infection are curing almost everyone who completes a course of
treatment, and drop-out rates during treatment are low, large 'real-world' cohort studies reported this week at The International Liver Congress in
The findings show that currently available treatments
delivered at large scale have the potential to eliminate hepatitis C in the
population, if they are affordable and if people can be diagnosed and engaged
Sofosbuvir/velpatasvir (Epclusa) is a pangenotypic once-daily single-pill treatment for
hepatitis C. It combines an NS5A inhibitor (sofosbuvir) and an
NS5B inhibitor (velpatasvir). It is dosed without ribavirin, for 12 weeks. Epclusa is marketed by Gilead Sciences.
Generic versions of the combination are also being manufactured in India.
- compensated cirrhosis
The earlier stage of
cirrhosis, during which the liver is damaged but still able to perform most of
its functions. See also ‘cirrhosis’ and ‘decompensated cirrhosis’.
- decompensated cirrhosis
The later stage of
cirrhosis, during which the liver cannot perform some vital functions and
complications occur. See also ‘cirrhosis’ and ‘compensated cirrhosis’.
Sofosbuvir/velpatasvir is one of the
simplified treatment options that can be prescribed without genotyping for
short-course treatment of hepatitis C with a low risk of adverse events. The
main alternative to Epclusa is
marketed by AbbVie, which is also a pangenotypic treatment that can be dosed
once-daily without ribavirin.
Dr Alessandria Mangia presented data on real-world treatment
outcomes in 5340 people in 12 clinical cohorts in Europe and North America
who began treatment prior to November 2018. The study excluded data on outcomes
in people with decompensated cirrhosis or a previous history of treatment with sofosbuvir
or daclatasvir, and outcomes of people treated for more than 12 weeks.
Cohort participants had a mean age of 54 years, 52% were
male, 3.7% had co-infection with HIV, 13.2% were current or former injecting
drug users, and 20.7% had compensated cirrhosis. Thirty per cent had genotype 1 infection
and 33% had genotype 3 infection.
By intent-to-treat analysis (everyone who started
treatment), 92.7% achieved a sustained virologic response 12 weeks after
completing treatment (SVR12). Of those who did not achieve SVR12, over
two-thirds were lost to follow-up and 26% discontinued treatment early for
unspecified reasons. Overall, 1.4% of those who started treatment experienced
Overall, less than one in 20 people were either lost
to follow-up or unable to complete the treatment course and it is likely that
these patients would respond to a future course of treatment if re-engaged in
By per-protocol analysis (everyone who completed a 12-week
course of treatment), 98.5% achieved an SVR. There was
no difference in treatment response by genotype or fibrosis stage, nor by
German researchers presented an analysis of treatment
outcomes in 1698 adults treated with glecaprevir/pibrentasvir (Maviret) who were included in the German
Hepatitis C-Registry (DHC-R). The study population was predominantly male (69%)
with a median age of 43 years. Fifty-three per cent had genotype 1 infection and
35% had genotype 3 infection. Most people (84%) had no previous treatment
experience and were free of cirrhosis, and so were treated for 8 weeks.
Just over one-quarter of the cohort was receiving opioid
substitution therapy, 3% were active drug users and 15% had a mental health
“These are all important comorbidities encountered in clinical practice that
often have led to treatment being deferred in the past,” explained Professor
Markus Cornberg from Hannover Medical School in Germany, who presented the
In the intent-to-treat population, the SVR rate at 12 weeks after the
end of glecaprevir/pibrentasvir treatment was 97% (964/998). There was no difference in response
rate by genotype or subgroup. Glecaprevir/pibrentasvir was generally well tolerated with three
people discontinuing due to adverse events. Six individuals had hepatitis C virus (HCV) reinfection post-treatment and five individuals had a virological relapse.
"We found G/P [glecaprevir/pibrentasvir] treatment to be safe and highly effective, and to lead to
significant improvements in reported physical and mental well-being, across
this large, primarily treatment-naive cohort of HCV-infected individuals with
typical comorbidies," said Professor Cornberg.