An eight-week course of
treatment with the combination of glecaprevir and pibrentasvir (Maviret) is highly effective in curing
hepatitis C infection in people without cirrhosis, results of two real-world
studies presented at the 2018 International Liver Congress in Paris show.
Preliminary results of the studies, carried out in cohorts of patients in Germany
and Italy, confirm the results of clinical trials that led to the registration
of Maviret. In the German study, all
people without cirrhosis who started treatment were cured after eight weeks
of treatment and in the Italian study 97.7% of people were cured.
“These data are important because they confirm the high cure
rates of more than 98% observed in phase 3 trials,” said Professor Markus
Cornberg of the Hannover Medical School, Germany, and EASL Governing Board
Member. “Eight weeks of therapy is possible for all naïve, non-cirrhotic
patients, regardless of genotype.”
- 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’.
Glecaprevir/pibrentasvir is a pangenotypic treatment for
hepatitis C. An 8-week treatment course is approved for use in the European
Union in all previously untreated people without cirrhosis, regardless of
genotype. These recommendations are based on the results of phase 3 clinical
trials and may not reflect the real-world performance of drugs.
To assess the performance of glecaprevir/pibrentasvir in
German patients, Dr Thomas Berg of the University of Leipzig and colleagues looked at data from the German Hepatitis C-Registry. The registry compiles data on all German
patients with hepatitis C treated by private practitioners, who make up a large
proportion of physicians treating hepatitis C patients in the German healthcare system.
Individuals were included in the analysis if they did not have cirrhosis or had compensated cirrhosis and were previously untreated or had
received only interferon-based treatment for hepatitis C in the past. Three
hundred and seventeen eligible people have begun treatment with
glecaprevir/pibrentasvir since the regimen was approved in July 2017. Of these,
271 have end-of-treatment viral load results available and 96 have 12-week
post-treatment virological results available.
People receiving the 8-week Maviret regimen were predominantly male (68%) and previously
untreated (90%), with a median age of 47 years. The predominant genotypes were
1a (34%) and 3 (35%). Only 7% had compensated cirrhosis and the baseline APRI
score was below 1 in 79% of people, indicating good liver function and less
advanced fibrosis. Twenty-six per cent were receiving opioid substitution
“It’s a very healthy cohort and it’s our impression that
most patients with advanced disease are already treated in Germany. This cohort
are younger and more likely to be drug users,” said Dr Berg, a view echoed by Professor
“Most of the patients that we will need to treat in the
future to eliminate hepatitis C are less advanced and easier to treat,” he told
a press conference. “We want to avoid late presenters in HCV [hepatitis C virus], just as in HIV.”
Intent-to-treat analysis showed that 97% achieved a
sustained virologic response 12 weeks after treatment. One person was lost to
follow-up and two people discontinued treatment due to adverse events that
were not study drug-related. One person suffered a serious adverse event –
Meniere’s disease – thought to be possibly study drug-related. Liver enzyme
elevations were very rare, affecting less than 1% of people.
In a second study, Italian investigators examined the
outcomes of 639 people who received an 8-week course of treatment with
glecaprevir/pibrentasvir and 84 who received a 12 or 16-week course of
treatment due to cirrhosis or previous treatment history.
Almost all the 8-week treatment cohort had mild fibrosis
(90% had F0-F2 fibrosis, the remainder F3 or F4). The median age of participants
was 58 years and 49% were male. Six per cent had HIV co-infection.
Interim results were available for 314 of the 8-week treatment
cohort patients who had week 4 post-treatment (SVR4) virological results
available and final data for 44 patients with SVR12 results were available. In each
group, one person had experienced post-treatment viral relapse, giving SVR4
and SVR12 results of 99.7% and 97.7% respectively. In those treated for 12 or
16 weeks 33 participants had SVR4 virological results
available. In all cases, viral load was undetectable (SVR4) and in five
people with 12-week post-treatment results viral load was undetectable in all
There was no substantive difference in virological response according
to genotype, fibrosis stage, age, baseline viral load, HIV status or size of treatment