At last year’s CROI conference, I wrote about a
6-week study of sofosbuvir, ledipasvir, and GS-9451. This combination
was tested against sofosbuvir/ledipasvir alone for 12 weeks and
sofosbuvir/ledipasvir plus GS-9669 for 6 weeks. The drugs were
combined into one-pill, taken once-daily. There were 20 patients in
each arm.
The bottom line is that all 20
patients (100%) achieved a cure in the triple combination of
sofosbuvir/ledipasvir and GS-9669 with 6 weeks of treatment. The most
common side effects were headache, fatigue and diarrhea.
Comments: This
study is a small study and there is currently no information that it
has yet entered into phase 3 studies. But given the high cure rates and
low side effects hopefully it will be entered into clinical trials
with this combination or perhaps Gilead is researching another
inhibitor to include.
Study: Virological
response after 6 week triple-drug regimens for hepatitis C: a
proof-of-concept phase 2A cohort study. Authors: A Kohli et al.
Exclusivity Deals
Ever since AbbVie’s VIEKIRA PAK’s approval there
have been intense negotiations between insurance companies/pharmacies
and AbbVie and Gilead to determine who will be the exclusive
distributors of the pharmaceutical HCV medications. These deals will
help to drive down the costs of the drugs, and this will hopefully
translate into more patients having access to HCV medications. The
real downside is that the decision as to which medication a patient
should be prescribed is now being made by someone other than a patient
and medical provider. This is very bad news for patients (see
"Predictors" article). The information below is from our blog as of
the date that we have put together our newsletter. If you have been
denied treatment in the past, you may want to check the list below (or
our
Blog) to find out if you would now qualify for insurance coverage. The agreements are on-going so keep checking back.
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AbbVie: Express Scripts, AIDS Drug Assistance Programs (ADAPs)
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Gilead: Aetna, Humana, Anthem, CVS
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Both—AbbVie/Gilead: Prime Therapeutics
Merck
In January, Merck announced that it has been
prioritizing portions of its drug development operations including
hepatitis C. In this respect, the development of a two-drug single
pill (grazoprevir/elbasvir) will be accelerated. Merck hopes to apply
for marketing approval in the first half of 2015. The combination is
currently in phase 3 studies. Phase 2 studies of the two drug
combination with and without ribavirin in multiple arm studies of
monoinfected and HIV/HCV coinfected patient populations with and
without cirrhosis resulted in cure rates from 90 to 100%. The most
common side effects were fatigue, headache and general weakness.
Gilead
Gilead has announced that it has expanded its
hepatitis C generic licensing agreements to include the investigational
NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical
studies as part of a single tablet regimen that combines the compound
and sofosbuvir for the treatment of all six genotypes of hepatitis C. If
approved by regulatory authorities, the sofosbuvir/GS-5816 regimen
would become the first pan-genotypic, all-oral single tablet regimen for
HCV. A pan-genotypic therapeutic option is particularly important for
developing countries, where genotype testing is often unreliable or not
readily available.
http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#2Labels: alan franciscus, Exclusivity Deals, Gilead, grazoprevir/elbasvir (MK-5172/MK-8742), HCV Drugs, Merck, pan-genotypic, Sofosbuvir/GS-5816 Single Tablet Regimen