Boceprevir Gains FDA Approval for Hepatitis C
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Merck Gets FDA Approval For Chronic Hepatitis C Drug Victrelis - Quick Facts .
(RTTNews) - Merck & Co. Inc. (MRK: News ) Friday said FDA has approved its new drug Victrelis for the treatment of chronic hepatitis C.
(RTTNews) - Merck & Co. Inc. (MRK: News ) Friday said FDA has approved its new drug Victrelis for the treatment of chronic hepatitis C.
Victrelis, or boceprevir, is approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Merck said that it will begin the shipping of Victrelis to pharmacies within a week so that patients will have access to this new medication as soon as possible.
Separately, Merck will also add Victrelis to its patient assistance program through which eligible patients may be able to receive product free of charge.
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Boceprevir Approved,
by Dr. Joe Galati on May 13, 2011
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It was just announced by Merck that Boceprevir has been approved by the FDA in the treatment of chronic hepatitis C. The Wall Street Journal has posted this brief release. Business Wire released this press briefing. The commercial name for the new Merck product is VICTRELIS.
For patients around the country, this will usher in a new era in hepatitis C treatment options. My advise to patients (of mine) and others that have previously been treated with any of the hepatitis C medications in the past:
Obtain all of your old medical records from past treatment courses.
If you had prior liver biopsies, obtain these results.
In speaking with your HCV treatment team of care providers, classify yourself as one of the following response categories: Non-responder, partial responder, responder-relapser, or a null responder. This will help us best treat previously exposed patients who now need re-treatment.
FDA Approves Merck's VICTRELIS(TM) (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
May 13, 2011 (Business Wire) -- Merck (NYSE:MRK) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS™ (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
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- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
- VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
- Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR)1, and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.,
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VICTRELIS is the first in a new class of medicines approved to treat chronic hepatitis C
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VICTRELIS is the first in a new class of medicines known as hepatitis C virus (HCV) protease inhibitors approved for use in combination with peginterferon alfa and ribavirin, which is the current standard therapy, for the treatment of chronic hepatitis C.
“This is an exciting day for physicians and patients because VICTRELIS is the first major advancement for the treatment of chronic hepatitis C approved in a decade,” said Bruce Bacon, M.D., professor of internal medicine, Saint Louis University School of Medicine, and a clinical investigator for VICTRELIS. “Compared to current standard therapy, VICTRELIS can significantly increase a patient’s chance of achieving undetectable levels of the virus, thereby obtaining an SVR. For many patients, VICTRELIS may allow for a shorter total duration of treatment.”
“Merck is deeply committed to innovation in bringing forward new medicines that significantly address unmet medical needs, and VICTRELIS is a shining example of our commitment being realized," said Kenneth C. Frazier, president and chief executive officer, Merck. "We look forward to building on our legacy in the fight against infectious diseases, and to being a part of this exciting new era in the treatment of chronic hepatitis C."
Merck will begin shipping VICTRELIS to pharmacies within a week so that patients will have access to this new medication as soon as possible. In addition, the company is expanding its support of public awareness and education programs for chronic hepatitis C. Resources include coupons to help eligible patients with their medication cost, reimbursement support to help patients understand their insurance coverage for VICTRELIS, and 24/7 nurse phone support.
Separately, Merck will also add VICTRELIS to its patient assistance program through which eligible patients may be able to receive product free of charge.
Current standard therapy for HCV works to strengthen the body’s natural immune response to the virus, but only about 40 percent of patients with chronic HCV genotype 1 infection are able to achieve SVR. VICTRELIS is a Direct Acting Antiviral (DAA) agent that interferes with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
The FDA approval of VICTRELIS is based on the efficacy and safety results from two large Phase III clinical studies that evaluated approximately 1,500 adult patients with chronic HCV genotype 1 infection. Both studies included two treatment arms with VICTRELIS: a response-guided therapy (RGT) arm, in which patients with undetectable virus (HCV-RNA) at treatment week 8 were eligible for a shorter duration of therapy, as well as a 48-week treatment arm. All patients receiving VICTRELIS in these studies were first treated with peginterferon alfa-2b and ribavirin (P/R) in a 4-week lead-in phase, followed by the addition of VICTRELIS after week 4. The studies also included a control arm in which patients received 48 weeks of treatment with P/R alone. Historical null responders were not enrolled.
Adding VICTRELIS to P/R achieved a significant increase in SVR rates compared to P/R alone
Primary results from the two pivotal studies:
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- Treatment-failure patients: the addition of VICTRELIS to P/R resulted in nearly a three-fold increase in SVR rates to 59 percent (96/162) for the RGT arm and 66 percent (106/161) for the 48-week treatment arm, compared to 23 percent (18/80) for control. Relapse rates were 14 percent (16/111) for the RGT arm and 12 percent (14/121) for the 48-week treatment arm, compared to 28 percent (7/25) for control.
- Treatment-naïve patients: the addition of VICTRELIS to P/R resulted in a significant increase (1.7 fold) in SVR rates to 63 percent (232/368) for the RGT arm and 66 percent (242/366) for the 48-week treatment arm, compared to 38 percent (138/363) for control. Relapse rates were 9 percent (24/257) for the RGT arm and 9 percent (24/265) for the 48-week treatment arm, compared to 22 percent (39/176) for control.
In a separate, pre-specified cohort of 159 Black treatment-naïve patients, the addition of VICTRELIS to P/R resulted in a significant increase in SVR to 42 percent (22/52) for the RGT arm and 53 percent (29/55) for the 48-week treatment arm, compared to 23 percent (12/52) for control. Relapse rates were 12 percent (3/25) for the RGT arm and 17 percent (6/35) for the 48-week treatment arm, compared to 14 percent (2/14) for control.
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Many patients receiving VICTRELIS in combination therapy were early responders at treatment week 8
Secondary analyses from the two pivotal studies were as follows:
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- Treatment-failure patients: 46 percent (74/162) of patients in the RGT arm and 52 percent (84/161) of patients in the 48-week treatment arm receiving VICTRELIS had undetectable virus (HCV-RNA) at treatment week 8 and were considered early responders, compared to 9 percent (7/80) for control. The SVR rate for these early responders was 88 percent (65/74) in the RGT arm and 88 percent (74/84) in the 48-week treatment arm, compared to 100 percent (7/7) for control. Early responders in the RGT arm were eligible to stop all treatment at week 36.
- Treatment-naïve patients: 57 percent (208/368) of patients in the RGT arm and 56 percent (204/366) of patients in the 48-week treatment arm receiving VICTRELIS had undetectable virus (HCV-RNA) at treatment week 8 and were considered early responders, compared to 17 percent (60/363) for control. The SVR rate for these early responders was 88 percent (184/208) in the RGT arm and 90 percent (184/204) in the 48-week treatment arm, compared to 85 percent (51/60) for control. Early responders in the RGT arm were eligible to stop all treatment at week 28.
SVR achieved with VICTRELIS in combination therapy in late responders
- Treatment-failure patients: Patients who had detectable virus (HCV-RNA) at treatment week 8, but undetectable virus (HCV-RNA) at treatment week 12, and completed at least 36 weeks of treatment, were considered late responders.
Boceprevir Wins FDA Approval to Treat Hepatitis C
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: May 13, 2011
WASHINGTON -- The FDA has approved the investigational drug boceprevir (Victrelis), to be used in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.Boceprevir, made by Merck, will be the first HCV protease inhibitor to reach market and is expected to be a major advance in treating the disease, which affects between three and four million people in U.S.
"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, MD, MPH, director of antimicrobial products at the FDA in a press release. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."
The move was expected after a committee of outside experts voted unanimously in April that the FDA should approve the drug.
The panelists all agreed that boceprevir seems to be a safe and effective new option to treat HCV.
The approval was based on Merck's clinical trials, which showed that, in the difficult-to-treat genotype 1 patients, boceprevir yielded sustained virological response rates as high as 67%.
In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.
Until now, treatment has relied on boosting the immune system rather than attacking the virus directly.
One panelist at the April meeting marveled at how far HCV treatment has come in the past several decades and said achieving a 60% or 70% sustained response "seems like a dream come true."
The drug carries a number of hematologic side effects, including anemia, neutropenia, and thrombocytopenia. But the advisory committee members said the anemia is a manageable side effect during treatment and is reversible after the drug has been stopped.
The FDA is widely expected to approve another protease inhibitor for HCV, telaprevir, made by Vertex Pharmaceuticals. The same panel that endorsed boceprevir also voted unanimously that telaprevir be approved for the same indication.
SILVER SPRING, Md., May 13, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.
When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.
Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.
"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.
Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.
People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.
Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).
Victrelis is marketed by Whitehouse Station, N.J.-based Merck.
For more information:
FDA: Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
FDA: What's New at FDA in Hepatitis
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocat
es/ucm151488.htm
FDA: Hepatitis C Tests
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
InVitroDiagnostics/HomeUseTests/ucm125785.htm
CDC: Hepatitis C Information for the Public
http://www.cdc.gov/hepatitis/C/index.htm
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.
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
RELATED LINKS
http://www.fda.gov/
The move was expected after a committee of outside experts voted unanimously in April that the FDA should approve the drug.
The panelists all agreed that boceprevir seems to be a safe and effective new option to treat HCV.
The approval was based on Merck's clinical trials, which showed that, in the difficult-to-treat genotype 1 patients, boceprevir yielded sustained virological response rates as high as 67%.
In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.
Until now, treatment has relied on boosting the immune system rather than attacking the virus directly.
One panelist at the April meeting marveled at how far HCV treatment has come in the past several decades and said achieving a 60% or 70% sustained response "seems like a dream come true."
The drug carries a number of hematologic side effects, including anemia, neutropenia, and thrombocytopenia. But the advisory committee members said the anemia is a manageable side effect during treatment and is reversible after the drug has been stopped.
The FDA is widely expected to approve another protease inhibitor for HCV, telaprevir, made by Vertex Pharmaceuticals. The same panel that endorsed boceprevir also voted unanimously that telaprevir be approved for the same indication.
SILVER SPRING, Md., May 13, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.
When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.
Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.
"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.
Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.
People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.
Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).
Victrelis is marketed by Whitehouse Station, N.J.-based Merck.
For more information:
FDA: Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
FDA: What's New at FDA in Hepatitis
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocat
es/ucm151488.htm
FDA: Hepatitis C Tests
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
InVitroDiagnostics/HomeUseTests/ucm125785.htm
CDC: Hepatitis C Information for the Public
http://www.cdc.gov/hepatitis/C/index.htm
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.
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
RELATED LINKS
http://www.fda.gov/
DOW JONES NEWSWIRES
Merck Wins FDA Approval To Launch Hepatitis C Drug
Merck & Co. (MRK) won U.S. regulatory approval to launch a new hepatitis C drug after the Food and Drug Administration evaluated the safety and effectiveness of the treatment in two phase-3 clinical trials.
On Friday, the FDA said it approved Vicrelis to treat some adults with chronic hepatitis C. The treatment is used for patients who still have some liver function, and who either haven't been previously treated with drug therapy for their hepatitis C or who have failed such treatment.
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the U.S. have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished function or failure of the organ.
Analysts see a multibillion-dollar market for a new crop of hepatitis C drugs. A competing treatment, telaprevir, from Vertex Pharmaceuticals Inc. (VRTX) and Johnson & Johnson (JNJ) is seen as having a competitive edge due to superior clinical-trial data. An FDA committee has also recommended approval for telaprevir
Merck's shares were off 0.1% at $37.03 in after-hours trading.
-By John Kell, Dow Jones Newswires; 212-416-2480; john.kell@dowjones.com
--Peter Loftus contributed to this article.
New On The Blog ; VICTRELIS™- Boceprevir: Prescribing Information and Medication Guide
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