Release
The U.S. Food and Drug Administration today approved Harvoni
(ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV)
genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV
genotype 1 infection. It is also the first approved regimen that does
not require administration with interferon or ribavirin, two
FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to
multiply. Sofosbuvir is a previously approved HCV drug marketed under
the brand name Sovaldi. Harvoni also contains a new drug called
ledipasvir.
“With the development and approval of new treatments for hepatitis C
virus, we are changing the treatment paradigm for Americans living with
the disease,” said Edward Cox, M.D., M.P.H., director of the Office of
Antimicrobial Products in the FDA’s Center for Drug Evaluation and
Research. “Until last year, the only available treatments for hepatitis C
virus required administration with interferon and ribavirin. Now,
patients and health care professionals have multiple treatment options,
including a combination pill to help simplify treatment regimens.”
Harvoni is the third drug approved by the FDA in the past year to
treat chronic HCV infection. The FDA approved Olysio (simeprevir) in
November 2013 and Sovaldi in December 2013.
Hepatitis C is a viral disease that causes inflammation of the liver
that can lead to diminished liver function or liver failure. Most people
infected with HCV have no symptoms of the disease until liver damage
becomes apparent, which may take decades.
Some people with chronic HCV infection develop scarring and poor
liver function (cirrhosis) over many years, which can lead to
complications such as bleeding, jaundice (yellowish eyes or skin), fluid
accumulation in the abdomen, infections and liver cancer. According to
the Centers for Disease Control and Prevention, about 3.2 million
Americans are infected with HCV, and without proper treatment, 15-30
percent of these people will go on to develop cirrhosis.
Harvoni’s efficacy was evaluated in three clinical trials enrolling
1,518 participants who had not previously received treatment for their
infection (treatment-naive) or had not responded to previous treatment
(treatment-experienced), including participants with cirrhosis.
Participants were randomly assigned to receive Harvoni with or without
ribavirin. The trials were designed to measure whether the hepatitis C
virus was no longer detected in the blood at least 12 weeks after
finishing treatment (sustained virologic response, or SVR), indicating
that a participant’s HCV infection has been cured.
In the first trial, comprised of treatment-naive participants, 94
percent of those who received Harvoni for eight weeks and 96 percent of
those who received Harvoni for 12 weeks achieved SVR. The second trial
showed 99 percent of such participants with and without cirrhosis
achieved SVR after 12 weeks. And in the third trial, which examined
Harvoni’s efficacy in treatment-experienced participants with and
without cirrhosis, 94 percent of those who received Harvoni for 12 weeks
and 99 percent of those who received Harvoni for 24 weeks achieved SVR.
In all trials, ribavirin did not increase response rates in the
participants.
The most common side effects reported in clinical trial participants were fatigue and headache.
Harvoni is the seventh new drug with breakthrough therapy designation
to receive FDA approval. The FDA can designate a drug as a breakthrough
therapy at the request of the sponsor if preliminary clinical evidence
indicates the drug may demonstrate a substantial improvement over
available therapies for patients with serious or life-threatening
diseases. Harvoni was reviewed under the FDA’s priority review program,
which provides for an expedited review of drugs that treat serious
conditions and, if approved, would provide significant improvement in
safety or effectiveness.
Harvoni and Sovaldi are marketed by Gilead, based in Foster City,
California. Olysio is marketed by Janssen Pharmaceutical based in
Raritan, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.
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Media
Page Last Updated: 10/10/2014
No último dia 10 de outubro, a FDA aprovou o HARVONI® da Gilead, uma combinação de dose fixa de ledipasvir - 90 mg (inibidor de NS5A do vírus HCV) com o sofosbuvir 400 mg. O HARVONI® é indicado para o tratamento de infecções da hepatite C crônica, genótipo 1, em adultos. O HARVONI® é a primeira pílula combinada aprovada para tratar a infecção crônica genótipo 1. O HARVONI® também é o primeiro regime aprovado que não requer administração com interferon e/ou ribavirina. A dosagem recomendada de HARVONI é um comprimido tomado por via oral uma vez por dia, com ou sem alimentos.
ResponderExcluirA dosagem recomendada de HARVONI é um comprimido tomado por via oral uma vez por dia, com ou sem alimentos.
Duração recomendada para tratamento com HARVONI em pacientes com HCV genótipo 1
População de pacientes / Duração Recomendada do Tratamento
Virgens de tratamento com ou sem cirrose / 12 semanas *
Experimentou-Tratamento ** sem cirrose / 12 semanas
Experimentou-Tratamento ** com cirrose / 24 semanas
* HARVONI durante 8 semanas pode ser considerado em pacientes virgens de tratamento sem cirrose que têm HCV RNA pré-tratamento a menos de 6 milhões de UI / mL.
** Pacientes previamente tratados que falharam o tratamento com peginterferon alfa + ribavirina ou um inibidor de protease do HCV + peginterferon alfa + ribavirina.
Não é necessário ajuste da dose de HARVONI para pacientes com insuficiência renal ligeira ou moderada. Nenhuma recomendação de dose pode ser administrada em doentes com insuficiência renal grave (Taxa de filtração glomerular estimada [eGFR] (30 mL / min / 1.73m2) ou com doença renal terminal (DRT), devido a exposições mais elevadas (até 20 vezes) de o metabolito predominante sofosbuvir.
Não é necessário ajuste da dose de HARVONI para pacientes com insuficiência hepática leve, moderada ou grave (Child-Pugh Classe A, B, ou C). A segurança e eficácia de HARVONI não foram estabelecidas em pacientes com cirrose descompensada.
Nos ensaios clínicos realizados em 1.518 pacientes tratados com "Harvoni®" em tratamento de 12 semanas, 96% dos pacientes nunca antes tratados resultaram curados. Considerando os que não tinham cirrose, a cura foi de 99% dos pacientes. Em pacientes não respondedores a um tratamento anterior a cura foi de 94% e, também, entre os não respondedores ao tratamento anterior que receberam 24 semanas de tratamento, a cura foi de 99%.
O Harvoni® ainda não está à venda. Deverá passar a ser comercializado nos próximos dias. Ainda não se conhece o preço a que será vendido.
Os efeitos adversos mais comuns observados nos ensaios clínicos afetaram menos de 5% dos pacientes e foram: fadiga, dor de cabeça, náuseas, diarreia e insônia.
É difícil prever quando será aprovado o Harvoni® em outros países, pois isso depende da velocidade com que atuam as agencias reguladoras.
Agradeço aos advogados que me orientaram. Consegui acessar meu tratamento, valeu à pena. Fica aqui meu registro de gratidão ao Dr. Rodrigues de França, que Deus lhe ilumine e proteja! Ass. Rubens.
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