New Hepatitis C Drugs In The News; Telaprevir and Boceprevir
- File Under boceprevir, HCV News, telaprevir
April 28 The FDA advisory panel unanimously backed the approval of Vertex Pharmaceuticals proposed hepatitis C-drug telaprevir.
April 27 - VICTRELIS (boceprevir) was unanimously recommended for approval by the FDA Advisory Committee .
In The News;
FDA Panel Endorses Boceprevir for Hepatitis C
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: April 27, 2011
SILVER SPRING, Md. --
An FDA advisory committee has voted unanimously to recommend approval of the investigational drug boceprevir (Victrelis), in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.
The agency's Antiviral Drugs Advisory Committee voted 18-0 Wednesday that boceprevir, made by Merck, appears to be a safe and effective new option to treat a disease that affects between three and four million people in U.S.
The panel was expected to endorse the drug -- and the FDA is expected to approve it -- since clinical trials 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%.
The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during the panel's two-day meeting this week. The other is telaprevir -- slated for review on Thursday -- which exhibited even higher sustained response rates than boceprevir.
If the FDA approves the two new drugs as expected, they would be the first HCV protease inhibitors to reach market and are thought to represent a major advance in therapy for genotype 1 hepatitis C.
Until now, treatment has relied on boosting the immune system, rather than attacking the virus directly.
Panelist Lawrence Friedman, MD, chair of the Department of Medicine at Newton-Wellesley Hospital in Newton, Mass., said when he first started seeing HCV patients, there was no treatment at all.
"To go to 60% or 70% [sustained response] really seems like a dream come true," he said. "I think this is a major advance, so I'm very enthusiastic about this drug."
Both boceprevir and telaprevir have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.
On Wednesday, the panel discussed Merck's trial data, which suggest that adding boceprevir to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates among certain subsets of patients.
For instance, in one of the trials, in patients who had never been treated for HCV, 40% of the control group receiving the conventional regimen had a sustained response versus about 70% of patients with boceprevir added.
Analyzing data of patients with previous partial or unsustained responses to the standard regimen showed that 21% achieved a sustained response with a second round of the same treatment, whereas approximately 60% did when that second round included boceprevir.
The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on how well a patient was responding to treatment after eight and 24 weeks.
Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.
But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated.
Panelists also discussed the hematologic side effects associated with boceprevir -- including anemia, neutropenia, and thrombocytopenia -- all of which were more common in patients treated with boceprevir -- but they were ultimately convinced that anemia is a manageable side effect during treatment with boceprevir and is reversible after the drug is stopped.
The FDA is expected to make decisions on both boceprevir and telaprevir in May and physicians who treat HCV patients are eagerly awaiting approval. The anticipation has led some doctors to postpone treatment until the drugs are available, according to Donald Gardenier, DNP, of Mount Sinai School of Medicine in New York City.
The delays are based on the expectation that "the new treatments will be both more effective and administered over shorter courses," Gardenier said in an email to MedPage Today.
For most patients, the delay will have "little or no downside," he said.
"Chronic hepatitis C progresses slowly and the goal of treatment is to prevent the long-term consequences, so a delay of a few months is not significant for most patients," Gardenier said.
In some cases, such as where liver disease is advanced, doctors would go ahead with standard treatment, he added, "although that happens less frequently as the availability of the new medications comes closer."
Once the drug is approved, it still has to be made and shipped and insurers need to agree to pay for it, he noted. Currently, experts are expecting to see the drug in the clinic by late summer or early fall.
"In the meantime, we are actively planning for handling what we anticipate will be a corresponding increase in patient volume," Gardenier said.
New Drugs For Hepatitis C Called Game Changers
April 28
Advisory committee members also complained about the lack of information on African-American patients, who often don't respond as well to standard hepatitis C therapy. Cargill, who specializes in treating minorities with HIV infection, says this is a big concern. "I practice in a setting where approximately 95 percent of our patients are co-infected with hepatitis C" and HIV, she says.
Committee members also worry about the complexity of taking the new drugs (which are added to conventional treatments), patients' ability to adhere to treatment, the need to monitor them for signs of anemia, and the drugs' value for patients who have not responded to standard treatment.
USciences Hosts Making the Connections: A Panel Discussion on Hepatitis C Prevention and Treatment
Published: April 27, 2011
SILVER SPRING, Md. --
An FDA advisory committee has voted unanimously to recommend approval of the investigational drug boceprevir (Victrelis), in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.
The agency's Antiviral Drugs Advisory Committee voted 18-0 Wednesday that boceprevir, made by Merck, appears to be a safe and effective new option to treat a disease that affects between three and four million people in U.S.
The panel was expected to endorse the drug -- and the FDA is expected to approve it -- since clinical trials 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%.
The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during the panel's two-day meeting this week. The other is telaprevir -- slated for review on Thursday -- which exhibited even higher sustained response rates than boceprevir.
If the FDA approves the two new drugs as expected, they would be the first HCV protease inhibitors to reach market and are thought to represent a major advance in therapy for genotype 1 hepatitis C.
Until now, treatment has relied on boosting the immune system, rather than attacking the virus directly.
Panelist Lawrence Friedman, MD, chair of the Department of Medicine at Newton-Wellesley Hospital in Newton, Mass., said when he first started seeing HCV patients, there was no treatment at all.
"To go to 60% or 70% [sustained response] really seems like a dream come true," he said. "I think this is a major advance, so I'm very enthusiastic about this drug."
Both boceprevir and telaprevir have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.
On Wednesday, the panel discussed Merck's trial data, which suggest that adding boceprevir to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates among certain subsets of patients.
For instance, in one of the trials, in patients who had never been treated for HCV, 40% of the control group receiving the conventional regimen had a sustained response versus about 70% of patients with boceprevir added.
Analyzing data of patients with previous partial or unsustained responses to the standard regimen showed that 21% achieved a sustained response with a second round of the same treatment, whereas approximately 60% did when that second round included boceprevir.
The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on how well a patient was responding to treatment after eight and 24 weeks.
Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.
But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated.
Panelists also discussed the hematologic side effects associated with boceprevir -- including anemia, neutropenia, and thrombocytopenia -- all of which were more common in patients treated with boceprevir -- but they were ultimately convinced that anemia is a manageable side effect during treatment with boceprevir and is reversible after the drug is stopped.
The FDA is expected to make decisions on both boceprevir and telaprevir in May and physicians who treat HCV patients are eagerly awaiting approval. The anticipation has led some doctors to postpone treatment until the drugs are available, according to Donald Gardenier, DNP, of Mount Sinai School of Medicine in New York City.
The delays are based on the expectation that "the new treatments will be both more effective and administered over shorter courses," Gardenier said in an email to MedPage Today.
For most patients, the delay will have "little or no downside," he said.
"Chronic hepatitis C progresses slowly and the goal of treatment is to prevent the long-term consequences, so a delay of a few months is not significant for most patients," Gardenier said.
In some cases, such as where liver disease is advanced, doctors would go ahead with standard treatment, he added, "although that happens less frequently as the availability of the new medications comes closer."
Once the drug is approved, it still has to be made and shipped and insurers need to agree to pay for it, he noted. Currently, experts are expecting to see the drug in the clinic by late summer or early fall.
"In the meantime, we are actively planning for handling what we anticipate will be a corresponding increase in patient volume," Gardenier said.
New Drugs For Hepatitis C Called Game Changers
With declarations that a new day is dawning in the treatment of hepatitis C, members of a federal advisory panel unanimously approved the first of two new drugs to treat the stubborn liver infection on Wednesday.
The committee is expected to green light the second hep-C drug today. Few doubt the Food and Drug Administration will clear the new drugs for market, possibly as soon as next month."This changes the game completely," says Dr. Victoria Cargill of the National Institutes of Health, acting chair of the FDA's advisory committee. "I can look into the faces of the people (with hepatitis C) and offer them some hope."
"I can't wait to get back and talk to my patients about it," enthused panel member Dr. Barbara McGovern of Tufts Medical School in Boston.
Studies show that the new drugs – so-called protease inhibitors that interfere with the hep-C virus' ability to replicate – eliminate the virus in 65 to 80 percent of patients. Standard treatments, which involve the drugs ribavirin and pegylated interfereon, cure less than half of patients.
Many patients with hepatitis C have reportedly been delaying treatment in the hope of more effective new drugs.
The drug approved Wednesday, by an 18-0 vote, is Merck's boceprevir, which will carry the brand name Victrelis. Studies indicate it is somewhat less effective than Vertex Pharmaceutical's telepravir, which is up for a vote today. Both are effective in many cases against the worst form of hepatitis C, type 1.
Analysts predict Merck will pull in around $800 million a year from boceprevir, while Vertex might sell $3 billion worth of teleprevir. At least 3.2 million Americans have hepatitis C. The strongest risk factors are a history of injection drug use, multiple sex partners and blood transfusion before 1992.
Yet enthusiasm for the drugs is tempered by a lot of questions about who is likely to benefit and how to manage serious side effects, such as anemia and severe rashes. The advisory panel came up with three dozen post-marketing studies it wants Merck to do."I do think you have to be somewhat of a Talmudic scholar to prescribe this drug," says panel member Dr. Lawrence Friedman of Massachusetts General Hospital.
That's because many hepatitis C patients were excluded from efficacy studies – for instance, if they had failed on standard treatments, or if they were resistant to conventional drugs.Advisory committee members also complained about the lack of information on African-American patients, who often don't respond as well to standard hepatitis C therapy. Cargill, who specializes in treating minorities with HIV infection, says this is a big concern. "I practice in a setting where approximately 95 percent of our patients are co-infected with hepatitis C" and HIV, she says.
Committee members also worry about the complexity of taking the new drugs (which are added to conventional treatments), patients' ability to adhere to treatment, the need to monitor them for signs of anemia, and the drugs' value for patients who have not responded to standard treatment.
But ultimately the panelists agreed that the benefits of the new pills clearly outweigh the risks. And this isn't the end of the story. Panel member Doris Strader of the University of Vermont points out that "there are drugs (for hepatitis C) coming along that may be better and simpler to use."
USciences Hosts Making the Connections: A Panel Discussion on Hepatitis C Prevention and Treatment
Released: 4/27/2011 5:00 PM EDT
Source: University of the Sciences
Newswise — Mayes College of Healthcare Business and Policy at University of the Sciences is hosting a panel discussion on hepatitis C prevention and treatment, on Thursday, April 28, 2011, from 5 to 7 p.m. The event will take place in the McNeil Science and Technology Center (43rd St. at Woodland Ave., Philadelphia, Pa. 19104).
The panel of distinguished panel speakers will discuss the impact of the national strategy for preventing and treating hepatitis C and how the new pipeline of drugs will impact public health and patient care in the greater Philadelphia region.
Moderator Andrew Peterson, PharmD, PhD, Dean of Mayes College of Healthcare Business and Policy at USciences, will guide the panel that includes:
• Martin Black, MD, Chief of the Liver Unit and Liver Transplantation Director at Temple University School of Medicine
• Amy Jessop, PhD, MPH, Director of HepTREC at USciences’ Mayes College
• Tracy Swan, Hepatitis/HIV Project Director for the Treatment Action Group
• John Ward, MD, Director of the Division of Viral Hepatitis at Centers for Disease Control and Prevention
Making the Connections: A Panel Discussion on Hepatitis C Prevention and Treatment is made possible by an unrestricted educational grant from AstraZeneca Pharmaceuticals. This panel discussion is a component of year-long theme focusing on hepatitis that Mayes College is incorporating into its culture through classroom work, events, speakers, and student activities.
At University of the Sciences, students embark on a challenging learning experience in a proving ground for successful professionals in the science and healthcare-related fields. A private institution dedicated to education, research, and service, and distinguished as the nation’s first college of pharmacy, the University has produced leaders in the science and healthcare marketplaces since its founding in 1821. Students in USciences’ five colleges learn to excel in scientific analysis and to apply their skills to improving healthcare in the lives of people worldwide through such disciplines as pharmacy, biology, physical therapy, healthcare business, and health policy. For more information, visit usciences.edu.
– Twitter @USciences –
Pediatric Liver Trial Misses Primary Endpoint
By Kristina Fiore, Staff Writer, MedPage Today
Published: April 26, 2011
Neither vitamin E nor metformin significantly decreased alanine aminotransferase (ALT) levels in children and adolescents with nonalcoholic fatty liver disease (NAFLD), researchers say.
But, although the trial missed this primary endpoint of significant reductions in ALT levels compared with placebo, the vitamin may be able to mitigate the more progressive form of the disease, Joel Lavine, MD, PhD, of Columbia University Medical Center in New York, and colleagues reported in the April 27 issue of the Journal of the American Medical Association.
"The data suggest that children treated with vitamin E who had biopsy-proven nonalcoholic steatohepatitis (NASH) had significant improvement in secondary histologic outcomes with vitamin E," they wrote...continue reading...
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