Feb 19 Gilead Sciences Inc said a
late-stage trial testing its experimental hepatitis C drug
showed no detectable virus level in 73 percent of study patients
after 16 weeks of therapy.
The study tested Gilead's sofosbuvir, in combination with a
standard drug for the infection, ribavirin, in patients with
genotype 2 or 3 of the virus who did not respond to prior
The study, named FUSION, showed that half of the patients in
the 12-week arm and 73 percent in the 16-week arm could suppress
the virus. The main goal was for the virus to be undetectable in
more than 25 percent of the study patients.
Fatigue, headache, insomnia and nausea were the most common
adverse effects reported in less than 15 percent of patients,
the biotechnology company said in a statement.
"With positive results from all four Phase 3 trials now in
hand, Gilead is on track to meet its goal of filing regulatory
applications in the United States and Europe in the second
quarter," Gilead Chief Scientific Officer Norbert Bischofberger
Earlier in the month, Gilead said the drug combination also
achieved main goals set in two other late-stage trials of
treating patients who have chronic hepatitis C virus infection
and have never been treated for it.
Sofosbuvir also showed promise in another late-stage study
called Positron in patients who were unable or unwilling to take
interferon -- a standard hepatitis C drug known for its
unpleasant side effects.
Gilead said it will present full data from the four studies
at a future scientific conference.
Shares of the company rose 2.5 percent to $42.60 in early
trade on the Nasdaq on Tuesday.