TWN
Info Service on Health Issues (Apr18/01)
12 April 2018
Third World Network
New affordable hepatitis C combination treatment shows 97% cure rate
Results
support a public health approach to hepatitis C
Drugs for Neglected Diseases initiative press release, 12 April 2018
PARIS,
12 April 2018 – An affordable hepatitis C combination treatment including
the new drug candidate ravidasvir has been shown to be safe and effective,
with extremely high cure rates for patients, including hard-to-treat
cases, according to interim results from the Phase II/III STORM-C-1
trial presented by the non-profit research and development organisation
Drugs for Neglected Diseases initiative (DNDi) at the
International Liver Conference in Paris.
“The results indicate that the sofosbuvir/ravidasvir combination is
comparable to the very best hepatitis C therapies available today
but it is priced affordably and could allow an alternative option
in countries excluded from pharmaceutical company access programs,”
said Bernard Pécoul Executive Director, DNDi.
The trial using medicines produced by Egyptian drug manufacturer Pharco
Pharmaceuticals was run by DNDi and co-sponsored by the Malaysian
Ministry of Health, in ten sites in Malaysia and Thailand. Agreements
signed in 2016 and 2017 enabling the trials and patient scale-up in
Malaysia set out a target price of US$300 for a 12-week treatment,
an almost 100% drop from existing treatment prices in Malaysia.
“As hepatitis C has become a major public health concern in Malaysia,
it is crucial to increase access to treatment for the benefit of the
nation,” said Datuk Dr Noor Hisham Abdullah Director General of Health,
Ministry of Health, Malaysia. In September 2017, the government
of Malaysia issued a “government-use” license on sofosbuvir patents
to allow 400,000 people living with hepatitis C in Malaysia to access
generic HCV regimens in public hospitals.
DNDi conducted the STORM-C-1 open label trial to assess the
efficacy, safety, tolerance and pharmacokinetics of the drug candidate
ravidasvir combined with sofosbuvir. 301 chronically infected adults
were treated with the ravidasvir/sofosbuvir combination for 12 weeks
for patients without cirrhosis of the liver, and for 24 weeks for
those with compensated cirrhosis. In accordance with international
standards defining cure for HCV treatments, 12 weeks after treatment
completion, 97% of those enrolled were cured (95% CI: 94.4-98.6).
Cure rates were very high even for the hardest-to-treat patients:
people with liver cirrhosis (96% cured), people living with HIV using
their usual treatment (97%), people infected with genotype 3 (97%)
including those with cirrhosis (96%), and people who had been exposed
to previous HCV treatments (96%). Importantly, patients combining
several of these risk factors were cured, and no unexpected safety
signals were detected.
“From a treatment provider perspective, this is very exciting as we
have been waiting for a simple, affordable, robust treatment tolerated
by all patients groups, including those whose treatment outcomes are
currently poorer, like patients under antiretroviral therapy,” said
Pierre Mendiharat, Deputy Operations Director for Médecins Sans Frontières
/ Doctors Without Borders (MSF). “This will be crucial to expand treatment
to the most vulnerable categories of patients in developing countries.”MSF
and DNDi are working together to increase access to care and treatment
for HCV patients in key low- and middle-income countries, through
the STORM-C project financed by MSF’s Transformational Investment
Capacity (TIC) initiative.
Over 71 million people live with hepatitis C worldwide, a disease
which causes 400,000 deaths a year. Although highly effective treatments
have existed for a number of years, less than three million people
are on treatment, with more people infected every year than are put
on treatment. The World Health Organization aims for 80% of people
diagnosed with HCV to be put on treatment by 2030.
Ravidasvir is an oral NS5A inhibitor licensed to DNDi by Presidio
Pharmaceuticals. Most people enrolled in the DNDi trial in Malaysia
and Thailand had genotype 1 (42% of participants) or genotype 3 (53%),
thereby confirming the combination’s effectiveness for those two additional
genotypes. Further trials are planned to document the efficacy and
safety of the combination in patients infected with the other HCV
genotypes and in particularly vulnerable groups, to enable a public
health approach to the treatment of hepatitis C
“Pharco is proud to enable a public health approach to hepatitis C
treatment by providing affordable treatments. We look forward to future
collaboration in additional clinical trials to confirm the safety
and efficacy of ravidasvir,” said Dr. Sherine Helmy, CEO, Pharco.
Poster reference: Isabelle Andrieux-Meyer, Tan Soek Siam,Nicolas
Salvadori, François Simon, Tim R. Cressey, Hajiah Rosaida Hi Mohd
Said, Muhammad Radzi Abu Hassan, Haniza Omar, Hoi-Poh Tee, Chan Wah
Kheong, Goh Khean Lee, Sharifah Faridah Syed Omar, Adeeba Kamarulzaman,
Suresh Kumar, Satawat Thongsawat, Kanawee Thetket, Anchalee Avihingsanon,
Suparat Khemnark, Sombat Thanprasertsuk, Jean-Michel Piedagnel, Sasikala
Siva, Nur Asimah, Nelson Da Silva, Jennifer Brenner, Bernard Pecoul,
Marc Lallemant, Shahnaz Murad. Safety and efficacy of ravidasvir plus
sofosbuvir 12 weeks in non-cirrhotic and 24 weeks in cirrhotic patients
with hepatitis C virus genotypes 1, 2, 3 and 6: the STORM-C-1 phase
II/III trial. International Liver Congress, Paris, April 11-15 2018,
France. Poster LBP-032.
About
DNDi
The
Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit
R&D organization working to deliver new treatments for neglected
patients, in particular sleeping sickness, Chagas disease, leishmaniasis,
filaria, paediatric HIV/AIDS, and hepatitis C. www.dndi.org