PAK™ AND THE HEPATITIS C PHARMACEUTICAL MARKET
December 19 (2014), the Food
and Drug Administration, approved Viekira pak™,
a package containing four different drugs for the treatment of hepatitis C genotype
1. Viekira pak™ is marketed by the pharmaceutical company AbbVie, whose headquarters is in Chicago, Illinois, United States.
Express Script, the main manager of US prescriptions,
said it will give funding for the use of this new pharmaceutical preparation to all patients, to the detriment of the two other
drugs for hepatitis C (Sovaldi®
 and Harvoni® [2, 3,
4]) by the rival company,
Gilead Sciences. Unlike what occurs with Sovaldi® and Harvoni®, the two drugs
by Gilead Sciences, whose funding
was subject to very restrictive criteria, the authorization
requirements of the new AbbVie drug
will allow the drug to reach more than 25 million patients in the US alone.
To achieve this, Express Script and AbbVie
have negotiated a discount and special
Gilead Sciences drugs have a price that
many experts and patient organizations consider
"outrageous"; a 12-week
treatment with Sovaldi® costs $84,000, and a 12-week treatment with Harvoni® requires
an outlay of $94,500.
Gilead Sciences said that the price of
their drugs reflects their “real” value in curing hepatitis
C. However, some state
programs such as Medicaid,
and the health programs of American prisons fully
recognize that they cannot afford these drugs on their annual
budgets. And so, the treatment with these drugs is limited to the most
severe patients. The US Congress has launched
an investigation into whether the prices are reasonable,
having filed lawsuits against the
manufacturer based on the Antitrust
Express Scripts has
gone further, promoting a boycott
of Gilead Sciences drugs, especially since the marketing of Viekira pak™.
However, many of the hopes for Viekira pak™
were dashed after the approval to make the cost of the new drug public by the FDA: $83,319 for
a 12-week course.
Negotiations between service companies
(insurance and asset management prescriptions)
and the laboratory determine the
position of each drug in the
Formulary, which is essential to establish which drug is used first
when there are several alternatives.
predict the exclusion of about 70 drugs
next year, including Harvoni®
and Sovaldi®, and the Olysio® [5, 6] ,
by Johnson & Johnson, which is also indicated for the
treatment of hepatitis C.
Most hepatologists declare that all patients with
hepatitis C should
be treated, regardless of the severity of their illness. However, there is some disagreement about the benefits of the Gilead Sciences drugs compared to the new AbbVie’ drug (Viekira pak™). While the latter requires
treatment with five daily tablets
(4 in the morning and one in the afternoon), sometimes associated with Ribavirin (with significant adverse side effects), treatment with Harvoni® is much more convenient because it is in the form of a single daily tablet.
Both Harvoni® and
Viekira pak™ have
been approved for hepatitis
C genotype 1, responsible
for approximately 70% of all
cases, and patients who began treatment
with Harvoni® or
Sovaldi® will not be forced to take Viekira pak™
Some aspects of the negotiations between
AbbVie and Express
Script have been revealed, and the manufacturer and marketer (AbbVie) has said that
patients requiring a 24-week course will not pay twice as much as those who
only require a 12-week course, and Express
Script said it will allow other medical
specialists, not only hepatologists, to prescribe the
Viekira pak ™
contains four drugs: Ombitavir, Paritaprevir, Ritonavir and Dasabuvir. The
first three are taken at the same
time in the morning (3 tablets) and Dasabuvir is to be taken twice a day.
In the European Union it has been
presented as Viekirax ™ (Ombitasvir / Paritaprevir / Ritonavir)
+ Exviera™ (Dasabuvir).
The European Commission’s decision to approve the treatment
is expected during the first quarter of
Viekira pak ™
is the fourth drug approved by the
Food and Drug Administration
after the approval
of Olysio® (Simeprevir),
in November 2013, followed by Sovaldi® (Sofosbuvir), in
December 2013 and Harvoni®
(association of Ledipasvir and Sofosbuvir), in
The authorization by the F.D.A. was justified based
on the results of six clinical
trials involving 2,308 patients with hepatitis C, both cirrhotic and
non-cirrhotic. All these studies
included a placebo (sugar pills) group.
These study groups (treated with Viekira pak®) could sometimes
include treatment with Ribavirin. The treatments had a 12 or
24 weeks of duration.
The criterion of cure was «sustained viral response» (SVR) which is the non-detection of hepatitis
C 12 weeks after
treatment terminated. The SVR
Treatment with Viekira pak™ consists of 3
tablets in the morning (12.5mg Paritaprevir
Ombitasvir + 75mg
+ 50mg Ritonavir)
and two daily 250mg tablets (morning and
evening) of Dasabuvir.
In clinical studies, the most common side effects were fatigue,
lethargy, nausea, altered sleeping pattern and itching.
Viekira pak™ is
the eleventh «breakthrough therapy» drug authorized by the FDA in the last
López-Tricas, JM. Sofosbuvir, a new drug against hepatitis C. European
Journal of Clinical Pharmacy-AF 2014; 16(4):
2.- Afdhal N., et al. ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated
HCV genotype 1 infection. N Engl J Med 2014; 370: 1483-93.
3.- Kowdley KV, et al. ION-3 Investigators. Ledipasvir
and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J
Med 2014; 370: 1879-88.
JM. http://www.info-farmacia.com/medico-farmaceuticos/informes-tecnicos/harvoni-nuevo-preparado-farmaceutico-contra-la-hepatitis-c. In: www.info-farmacia.com. Consult: December 2014.
5.- You DM, Pockros PJ.
Simeprevir for the treatment of chronic hepatitis C. Expert Opin Pharmacother
2013; 14: 2581-9.
6.- Vaidya A., Perry CM.
Simeprevir: first global approval. Drugs 2013; 73: 2093-2106.
Zaragoza, December 28th,