Anita Kohli from the
US National Institute of Allergy and
Infectious Diseases presented findings from the NIAID
SYNERGY trial, which
evaluated simple interferon- and ribavirin-free regimens of varying duration in
an inner-city population in Washington, DC.
This
analysis focused on 21 participants with HCV genotype 4 who were treated for 12
weeks with a once-daily
coformulation of Gilead Sciences' HCV polymerase inhibitor sofosbuvir and NS5A
inhibitor ledipasvir (approved and sold as Harvoni
in the US).
Two-third of
participants were men and the mean age was 55 years. About 40% were black and a
majority came from countries where genotype 4 is prevalent, including Cameroon,
Egypt and Ethiopia. Eight people (38%) had previously been treated for
hepatitis C but had not used direct-acting antivirals. 10% had stage F3 advanced
liver fibrosis and 33% had stage F4 compensated cirrhosis.
At 12 weeks after
completing treatment, all but one participant had undetectable HCV viral load,
for a sustained virological response (SVR12) rate of 95%. Response did not
differ according to previous treatment history or
extent of fibrosis.
Three-quarters of
participants experienced normalisation of alanine aminotransferase (ALT) liver
enzyme levels by week 4 of treatment, an indicator of reduced liver
inflammation.
Sofosbuvir/ledipasvir
was generally safe and well-tolerated. There were no deaths, serious adverse
events or grade 4 laboratory abnormalities; the three grade 3 abnormalities
were deemed not likely unrelated to treatment. The most common side-effects
were fatigue, diarrhoea and nausea. One participant discontinued therapy after
a single dose.
"Genotype 4 hepatitis C
infection can be successfully and safely treated with ledipasvir and sofosbuvir
for 12 weeks," the researchers concluded. "This regimen may prove
vital in the eradication of hepatitis C genotype 4, for which few therapeutic
options are in development."