[Ip-health] APN+, INPUD, ITPC, MDM, MSF & Act Up-Basel : Gilead’s HCV drug sofosbuvir approved by the FDA but accessible for how many?

Pauline Londeix pauline.londeix at gmail.com
Mon Dec 9 10:04:53 PST 2013

Dear all,

On Friday, the U.S. FDA approved Gilead’s sofosbuvir (Sovaldi), an
oral medication for the treatment of hepatitis C virus (HCV).
This treatment is great hope for millions of people with Hepatitis C worldwide.
But, how many people will be able to access it ?

Please find, at this link :
http://www.actupbasel.org/actupbasel/?Gilead-s-HCV-drug-sofosbuvir and
below, a joint press release by Act Up-Basel, Médecins sans
Frontières, Asia Pacific Network of People Living with HIV/AIDS,
Médecins du Monde, International Network of People who Use Drugs & the
International Treatment Preparedness Coalition : 'Gilead’s HCV drug
sofosbuvir approved by the FDA but accessible for how many?'

Une version en français est également disponible ici : Sofosbuvir, le
nouveau médicament de Gilead : un grand espoir pour les personnes
vivant avec l’hépatite C, mais combien y auront accès?

Best regards,
Pauline Londeix
Act Up-Basel


Gilead’s HCV drug sofosbuvir approved by the FDA but accessible for how many?
(Act Up-Basel, MSF, APN+, MDM, INPUD, ITPC)

• Press Release • December 9 • Bangkok – Paris – Basel – London – New York •

On December 6, the U.S. Food and Drug Administration approved Gilead’s
sofosbuvir (Sovaldi), an oral medication for the treatment of
hepatitis C virus (HCV). Sofosbuvir and other direct-acting antivirals
(DAAs) coming out of the drug development pipeline are more potent,
have fewer side effects, and can often be taken for a shorter duration
than the current standard of care. In clinical trials, sofosbuvir
demonstrated high cure rates of up to 100% when combined with other
DAAs. Yet its anticipated price tag of USD $80,000 will ensure that
this drug remains out of reach for the vast majority of people living
with HCV.

At least 185 million people worldwide have been infected with
hepatitis C virus (HCV). Each year, three to four million people are
newly infected and HCV-related liver complications kill an estimated
350,000 people annually, even though HCV is treatable and curable.
Currently, injectable pegylated interferon is the backbone of the
standard of care and, in combination with the oral drug Ribavirin
(RBV), has a cure rate of between 50 and 75% of cases, depending on
the HCV genotype; however, it is associated with significant side
effects. Drugs like sofosbuvir — Gilead’s “blockbuster” nucleotide
polymerase inhibitor — show much-improved cure rates (reaching up to
90-100% in clinical trials) and shorter treatment duration when
combined with pegylated interferon or other DAAs. Using newer DAAs,
especially if they can be used without the addition of pegylated
interferon, may result in a drastically lower incidence of side
effects and adverse reactions. Many more DAAs will enter the market
over the next couple of years.

Ninety percent of people who have hepatitis C live in low- and
middle-income countries (LMICs); most are not aware of their HCV
status, nor do they have access to testing and counselling. Most
people with chronic HCV do not have access to treatment, even under
the current standard of care, as pegylated interferon can cost up to
USD $18,000 per treatment course, or ten times their country’s per
capita Gross Domestic Product. Advocates are already fighting for
better accessibility to treatment programs and more affordable prices
of pegylated interferon. Accordingly, now is the time to ensure
affordable DAAs and optimized DAA combinations that reduce treatment
duration and improve both adherence and treatment outcomes for
everyone who needs them.

The price of sofosbuvir in high-income countries is expected to be
very high, between USD $80,000 – 90,000. Like other DAAs, sofosbuvir
is used in combination with other drugs, thus the total cost of a
treatment course will be even higher. In France, where sofosbuvir is
approved for early access, the 12-week course of treatment costs more
than USD $76,000 (USD $905 per pill). Analysts expect Gilead’s drug to
generate sales of USD $1.73 billion in 2014 alone.

Sofosbuvir and other DAAs coming out of late-stage development do not
have to cost this much. They can be produced generically for a tiny
fraction of that price, just like HIV antiretrovirals (ARVs). For
example, a 12-week course of sofosbuvir, produced generically, may
cost in the range of USD $68-136. Ensuring universal access to
affordably priced and generic DAAs could help eradicate HCV globally.

The HIV/AIDS pandemic demonstrated that corporate greed, rather than
the cost of drug development and production, caused originator drug
prices to be scandalously inflated. Generic competition led to radical
decreases in HIV drug prices: for some molecules they dropped by 99%
once generic versions became available, allowing millions more people
to access life-saving ARVs. Generic production also led to the
development of optimized fixed-dose combinations that have simplified
treatment, ensured access to ideal treatment combinations, and enabled
the development of pediatric versions and heat stable formulations.

We, people living with HCV, HIV/AIDS, people who use drugs, and our
advocates, demand that:

- Companies, Gilead specifically, as well as generics producers must
price their products close to the cost of production for all patients
in all LMICs; considering the cost of production per 12-week treatment
course (Ribavirin plus two DAAs) is estimated to range from USD $100
to 250.

 Companies should not hinder the production of generic medicines and
should not interfere with the obligation of governments to guarantee
the access to health for their population; including the right to
grant patents for real therapeutic inventions only, the right to
revoke abusive patents, and the right to issue compulsory licenses in
order to protect public health interests as clearly allowed by the
World Trade Organization’s TRIPS agreement (Agreements on Trade
related Aspects of Intellectual property rights) and reaffirmed in the
Doha Declaration.

 Governments must ensure that their intellectual property (IP) laws
promote, not impede, their obligation to their people’s right to
health. In particular, governments must use all safeguards to protect
public health, and where IP laws are not written to promote public
health, they should be revised accordingly.

We cannot allow more people to die from a treatable and curable
disease and must learn the lessons from HIV advocacy by demanding
affordable drug pricing for all, now! Failure to learn these lessons
would be an unforgiveable scandal.

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