Top News of 2014
—Alan Franciscus, Editor-in-Chief
was by far the most incredible year in hepatitis C (HCV) treatment
advances, but there was a lot of bad news about treatment access.
However, first let’s concentrate on the good news – all oral therapies
approved to treat hepatitis C.
We started the year with the
combination of Sovaldi (sofosbuvir), pegylated interferon and ribavirin
that had been approved in 2013 to treat genotypes 1 and 4. The
combination of Sovaldi (sofosbuvir) and ribavirin had also been approved
to treat genotypes 2 and 3. The combination of Sovaldi and Olysio
(simeprevir) with and without ribavirin was used off-label and later in
the year was approved by the Food and Drug Administration (FDA) to
treat hepatitis C genotype 1.
On October 10, 2014 the FDA approved the first interferon- and
ribavirin-free treatment for genotype 1—Harvoni
(sofosbuvir/ledipasvir). Harvoni combines both drugs into a pill taken
once daily. The majority of patients are treated for 12 weeks,
patients with minimal disease are treated for 8 weeks, and patients with
more severe disease can be treated for 24 weeks.
On December 19, 2014 the FDA
approved the second all oral HCV treatment—AbbVie’s 3D combination, now
called VIEKIRA PAK, to treat HCV genotype 1. In the “Pak” are three
drugs: ombitasvir, paritaprevir, and dasabuvir. The “PAK” also includes
another drug, ritonavir, that helps to increase the blood levels of
paritaprevir. VIEKIRA PAK is taken with and without ribavirin. The
treatment duration is 12 to 24 weeks. The cost of VIEKIRA PAK is
$83,319 for a 12-week course of treatment.
These are truly miraculous
drugs that in clinical trials have cured 90 – 100% of the patients
treated. The high cure rates in clinical trials are being replicated
in ‘real world’ settings—that is, patients in regular practice are
achieving similar cure rates. The new all oral drugs work for people
who have minimal disease, severe disease, pre- and post-transplant—in
other words everyone with HCV. This is truly spectacular!
The price of Sovaldi and
Harvoni has been a lightning rod in the news. The price is one piece of
the puzzle because if you looked at the historical pricing of HCV
treatment, Harvoni is actually about 10K to 20K higher (the duration of
therapy is shorter), but the side effects are minimal. Why the uproar? Because insurance
companies and government payers believe that there are thousands of
patients waiting for these therapies. This is the reason, they think,
that it will cripple Medicaid/Medicare. It has also been suggested
that the price of the all oral therapies could increase insurance
premiums for everyone including those without HCV.
THE HOPE: AbbVie’s
recently approved combo is coming in lower than Gilead’s. Express
Scripts announced a deep discount deal with AbbVie that will bring the
drugs to more patients. More deals = more patients treated.
Personally, the best news I’ve heard all year was
from people who have told me that they had been approved for the
treatment. I heard it from people who had been approved by their
insurance carrier. Approved by Medicaid. Approved by Medicare.
Approved by pharmaceutical compassionate care programs. I also heard
from many people who were treated and cured. I heard from people who
had been waiting for these treatments for many years who were treated
and cured. But I also heard from people who had not been approved—they
fought back, got the medications and were treated and cured. Of course
there were many people who I heard from who were denied. They had
never heard of the patient assistance programs. Some I heard back from
and some I didn’t hear back from. Some got approved, some gave up. I
just hope that the ones who fought back got approved. The message:
Fight back—you have nothing to lose!
THE BAD: Who
loses in the battle between pharmaceuticals and insurers/government?
It is always the people with hepatitis C who can’t get treated with
these life-saving drugs. If there was a ‘Shame Award’ it would be
awarded to these groups that are withholding these drugs from patients.
For those who are cured, and
want to leave all memory of HCV behind, think about one last gift of
advocacy: Help one person before you leave.
HCV WORLDWIDE: The
interferon-free therapies are being approved in other countries around
the world. Gilead has made sofosbuvir available in Egypt for a much
lower cost. Gilead has also reached an agreement with India to produce
it at a much lower cost. Daklinza (daclatasvir) in combination with
sofosbuvir, peginterferon, and ribavirin is approved by the Committee
for Medicinal Products for Human Use (CHMP) in the European Union.
CHMP has recommended the approval of Harvoni and Viekirax (VIEKIRA PAK
in the US). Canada has approved both Harvoni and HOLKIRA PAK (VIEKIRA
PAK in the US). Japan approved the dual therapy of Daklinza plus
Sunpreva (asunaprevir) to treat genotype 1. Unfortunately, insurance
companies and governments have been restricting access to the new
medications around the world, not only in the U.S.
In 2014, we launched a new
series of fact sheets ‘HCV Around the World’ to shine light on the
issues of hepatitis C in other countries. We would love to hear from
others around the world about their struggles and victories.
THE IGNORED: The
HCV epidemic among people who inject drugs continues to spread
throughout the United States especially among people in their 20’s.
There have been reports of outbreaks in Kentucky, Vermont, California,
Minnesota, and Wisconsin. This is occurring in rural, suburban and
urban areas. However, make no mistake this is an issue all over the
country, but it is not being tracked efficiently nor is it being
There is always one large outbreak of HCV due to unsafe infection
control practices. This year the outbreak was in a very vulnerable
population—the elderly—at a nursing home, Manor Care, in Minot, North
Dakota. So far, 51 cases have been identified. The source of the
infections is unknown.
I would like to end the article
on a good note, saying thanks to all of our readers for their kind
words. In spite of all the bad news I am optimistic that we will be
able to cure everyone of hepatitis C, especially now that we have these
amazing drugs; we just need to get these and the ones that are coming
down the pipeline to everyone who needs and deserves them.
So BA-BAM!!! We now have two all oral therapies to treat HCV. What a year it was! And we are well on our way.
On behalf of the staff of the
Hepatitis C Support Project and HCV Advocate, I would like to wish you
and your loved ones a happy and healthy 2015! Alan
Labels: Top News of 2014