—Alan Franciscus, Editor-in-Chief
drug development. This is likely due to the upcoming American
Association for the Study of Liver Diseases (AASLD) conference in
Boston, MA in November. There was, however, some important news that I
will recap in this month’s edition. Don’t forget that the AASLD
conference will feature a wealth of information about new drug
development from Gilead, Abbvie, Merck, Janssen as well as other
information related to hepatitis C and B. Please check our HCV and HBV
blog for the latest news and the December HCV Advocate newsletter for a recap of the most important updates.
As mentioned in our new HCV Advocate: Mid-Month Edition,
the Food and Drug Administration (FDA) approved the combination of
sofosbuvir plus ledipsavir in one pill, once-a-day—brand name Harvoni.
The Wholesale Acquisition Cost or WAC is $1,125 a pill or $63,000 for 8
weeks, $94,500 for 12 weeks, and $189,000 for 24 weeks of treatment.
The cure rates are 94% to 99%. The breakdown of the Phase 3 clinical
trials cure rates can be found here: http://hcvadvocate.org/hepatitis/
Bristol-Myers Squibb (BMS) announced on October 7,
2014 that it has decided to withdraw its FDA application for the
approval of the combination of daclatasvir and asunaprevir for the
treatment of people with HCV genotype 1b. However, BMS made it clear
that while they were discontinuing development of asunaprevir, they
were on track for the development of their other HCV inhibitors
including daclatasvir or BMS-791329, either of which can be combined
with sofosbuvir. Of note, daclatasvir is effective against HCV
genotypes 1, 2, 3 and 4. Genotype 3 drug development is important
as GT 3 is now considered the most difficult to
treat, and treatment choices are limited.
The current treatment for children with hepatitis C
is the combination of interferon plus ribavirin for 6 to 12 months.
Gilead will begin a new study on the combination of sofosbuvir plus
ribavirin in children with genotypes 2 or 3 in the United States,
Australia, Germany Italy, New Zealand, Russia, and the United Kingdom.
The study will determine the dose of sofosbuvir and treatment duration
that is needed to treat children. There are up to an estimated
46,000 children (aged 4 through 19) who are infected with hepatitis C.
This number is expected to dramatically rise in the near future because
of the increase in heroin and opioid injection drug use among males
and females. The difference in the new HCV epidemic is that the number
of people who inject drugs is believed to be equally distributed among
men and women. Approximately 5% of babies born to HCV-positive women
are infected with hepatitis C. As a result there will be more children
who will need to have better therapies that are easier to tolerate, and
with higher cure rates.
Medivir announced that
they are beginning a 12-week phase 2 study of simeprevir, daclatasvir
and sofosbuvir in people with hepatitis C genotypes 1 and 4. The study
will include treatment naïve and treatment experienced as well as
people with decompensated disease. If this triple doesn’t cure
everyone, I don’t know what will.