This month’s edition of HCV Drugs
will be short due to the upcoming European Association for the Study
of the Liver (EASL) conference. Join us for extensive coverage on
www.hcvadvocate.org for the latest news and the next edition of the HCV Advocate
newsletter. There is, however, important news included in this
issue: Merck is granted Breakthrough Therapy designation; phase 2
study results of AbbVie’s combo to treat genotype 4; and, lastly not
really drug-related, a new study that is being sponsored by the
National Institutes of Health (NIH) that may finally help expand care
and treatment to other medical providers.
Just when we thought that
the Food and Drug Administration (FDA) had rescinded Breakthrough
Therapy designation for all HCV therapies – we were wrong—they have
given it to Merck’s combination of grazoprevir plus elbasvir for the
treatment of people with HCV genotype 1 who have end-stage renal
(kidney) disease on hemodialysis and for people with HCV genotype 4.
The designation will allow for expedited review and approval.
two groups are definitely in need of expedited review! This is very
good news for people living with hepatitis C. Merck has this
combination of medications in multiple studies.
Source: Company press release
Results from a small phase 2 trial was recently published in The Lancet.
The trial included 86 HCV genotype 4 patients who had never been
treated (treatment naïve) as well as those who had been treated
previously (treatment-experienced). The patients were treated with
ombitasvir (once-daily), paritaprevir/ritonavir—with and without
ribavirin (twice daily) for 12 weeks.
Forty-nine patients who had
previously received treatment (treatment-experienced) received the
AbbVie combination treatment plus ribavirin for 12 weeks.
In the treatment-naïve group the
cure rate was 100% in the group that received ribavirin and 91% in the
group that did not receive ribavirin. In the treatment-experienced
group the cure rate was 100%.
good news for patients—although genotype 4 is uncommon in the United
States it is estimated that about 13% of the global population (mostly
in Egypt) is infected with genotype 4. However, when I conduct
training workshops it always surprises me that there is usually one or
more persons with genotype 4!
Source: Hézode C et
al. Ombitasvir plus paritaprevir plus ritonavir with or without
ribavirin in treatment-naive and treatment-experienced patients with
genotype 4 chronic hepatitis C virus infection (PEARL-I): A randomised,
open-label trial. Lancet 2015 Mar 30; [e-pub].
The NIH and the city of Washington, D. C., with
support from the NIH Office of AIDS Research has launched a study that
will include 600 patients with HCV or HIV/HCV coinfection. Of the
patients enrolled, 350 will continue with their current specialist, and
250 will be assigned to a primary care doctor, physician, physician
assistant or nurse practitioner for treatment. The treatment will be
Harvoni for two to six months.
has always been a lack of medical providers to manage and treat people
with hepatitis C. This is increasingly becoming a problem due to the
increased awareness, testing and treatments that are easier to tolerate
and more effective. Hopefully, this will show that more medical
providers can safely and effectively manage and treat people with
Source: NIH News press release
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