April 2 A pivotal trial of Gilead Sciences Inc's
hepatitis C drug sofosbuvir, sold under the brand name
Sovaldi in the United States, showed that the drug is safe and
effective in treating Japanese patients infected with a common
form of the virus.
Gilead, based in Foster City, California, said on Wednesday
it expects to file by mid-year for regulatory approval of the
pill in Japan.
The trial involved 153 patients infected with genotype 2
hepatitis C, which the most common form of the liver-destroying
virus in Japan and China.
Gilead said the study met its goal, showing that 98 percent
of previously-untreated patients achieved undetectable levels of
the virus three months after completing 12 weeks of treatment
with a combination of sofosbuvir and ribavirin. For
previously-treated patients, the response rate was 95 percent.
Side effects seen in the trial included anemia and headache.
Wall Street analysts, on average, have forecast Sovaldi
sales of $9.1 billion in 2017, according to Thomson Reuters
(Reporting by Deena Beasley; Editing by Marguerita Choy)