Research Fuels Hope for Hard-To-Treat Hepatitis C Patients
Released: 12/6/2010 12:00 PM EST
Source: Saint Louis University Medical Center
Newswise — The outlook for patients with hepatitis C continues to improve as results from a clinical trial led by a Saint Louis University researcher found that the drug boceprevir helped cure hard-to-treat patients. The findings were reported at the 61st annual meeting of the American Association for the Study of Liver Disease’s earlier in November.
Bruce R. Bacon, M.D., professor of internal medicine at Saint Louis University School of Medicine and co-principal investigator of the HCV RESPOND-2 study, studied the protease inhibitor, boceprevir, and found that it significantly increased the number of patients whose blood had undetectable levels of the virus.
“These findings are especially significant for patients who don’t respond to initial treatment,” said Bacon. “When the hepatitis C virus is not eliminated, debilitating fatigue and more serious problems can follow.”
Hepatitis C is caused by a virus that is transmitted by contact with blood. The infection may initially be asymptomatic, but for patients who develop chronic hepatitis C infection, inflammation of the liver may develop, leading to fibrosis and cirrhosis (scarring of the liver), as well as other complications including liver cancer and death.
The prognosis varies for patients with chronic hepatitis C. With the current standard therapy, about half fully recover after an initial course of peginterferon and ribavirin anti-viral therapy that may last from six months to a year.
The remaining patients, known as non-responders, may improve with initial treatment but the virus is not eliminated, or may not respond to treatment at all.
For this group, the only current option is to retreat patients with the same or similar drugs, which increases the likelihood of severe treatment side-effects. In addition, researchers have found that the success of treatment depends on the major strain, or genotype, of hepatitis C that a patient has.
The HCV RESPOND-2 study looked at 403 patients with chronic hepatitis C infections with genotype one, the most difficult strain of the virus to treat, who still had significant levels of the virus after being treated with peginterferon and ribavirin, the standard hepatitis C treatment.
"These results are very exciting," Bacon said. “In this study, boceprevir helped cure significantly more patients in 24 weeks of therapy than did treatment with peginterferon and ribavirin alone."
A second study, HCV SPRINT-2, examined patients with hepatitis C with genotype one who had not yet been treated with the standard treatment. They, too, responded well to the drug.
Bacon calls the progress made in treating hepatitis C remarkable.
“We’ve gone from the discovery of the virus in 1989 to where we are now, 22 years later, when we have the ability to cure a large majority of those with hepatitis C,” Bacon said. “It’s a true success story.”
“Drugs like boceprevir are going to revolutionize care of those with hepatitis C.”
The clinical trial was funded by Merck, which expects to begin seeking FDA approval this year.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
Showing posts with label respond-2. Show all posts
Showing posts with label respond-2. Show all posts
Monday, December 6, 2010
Wednesday, August 4, 2010
The Street.com picks a winner in the battle of the STAT-C agents....
WHITEHOUSE STATION, NJ (TheStreet) -- Vertex Pharmaceuticals(VRTX) defeats Merck(MRK) in the first battle of the hepatitis C drug war.
Merck said Wednesday that between 63% and 66% of hepatitis C patients never treated before achieved a viral cure after receiving the company's experimental drug boceprevir plus the standard of care, according to top-line results from a phase III study known as SPRINT-2.
These boceprevir cure rates were significantly higher than the 38% of hepatitis C patients cured using standard of care alone. On these data, Merck said it will seek approval of boceprevir in the U.S. and Europe by the end of the year.
If approved, boceprevir may have a tough time competing against Vertex's hepatitis C drug telaprevir, which will also be filed for approval later this year. Results from a similar Vertex study in so-called "treatment-naïve" hepatitis C patients released in May showed that telaprevir plus the standard of care achieved a cure rate of 75%.
Moreover, patients can be cured of the hepatitis C virus using Vertex's telaprevir in as little as 24 weeks, while the shortest treatment duration with Merck's boceprevir is 28 weeks.
It's important to note that boceprevir and telaprevir have never been matched head to head in a single study, but that doesn't stop analysts and investors from comparing the efficacy and safety of the two drugs.
"The [boceprevir] data look ok from an efficacy and safety standpoint but we believe that they are inferior to what telaprevir has demonstrated thus far," wrote ISI Group biotech analyst Mark Schoenebaum in an email to clients soon after Wednesday's announcement.
In early trading, Vertex shares were up 5% to $37.04. Merck was essentially flat at $34.85.
Merck Wednesday also released data from a second phase III study known as RESPOND-2 which tested boceprevir in patients who previously failed to respond to treatment with standard of care.
In this study, cure rates for boceprevir patients (who also received standard of care therapy) ranged from 59% to 66%. By comparison, patients who were re-treated with standard of care achieved cure rates of 21%.
Vertex is running a similar study of telaprevir in treatment-experience hepatitis C patients, with results expected in September.
Full data presentations for both telaprevir and boceprevir will be made at the American Association for the Liver Disease (AASLD) annual meeting in early November.
Merck said Wednesday that between 63% and 66% of hepatitis C patients never treated before achieved a viral cure after receiving the company's experimental drug boceprevir plus the standard of care, according to top-line results from a phase III study known as SPRINT-2.
These boceprevir cure rates were significantly higher than the 38% of hepatitis C patients cured using standard of care alone. On these data, Merck said it will seek approval of boceprevir in the U.S. and Europe by the end of the year.
If approved, boceprevir may have a tough time competing against Vertex's hepatitis C drug telaprevir, which will also be filed for approval later this year. Results from a similar Vertex study in so-called "treatment-naïve" hepatitis C patients released in May showed that telaprevir plus the standard of care achieved a cure rate of 75%.
Moreover, patients can be cured of the hepatitis C virus using Vertex's telaprevir in as little as 24 weeks, while the shortest treatment duration with Merck's boceprevir is 28 weeks.
It's important to note that boceprevir and telaprevir have never been matched head to head in a single study, but that doesn't stop analysts and investors from comparing the efficacy and safety of the two drugs.
"The [boceprevir] data look ok from an efficacy and safety standpoint but we believe that they are inferior to what telaprevir has demonstrated thus far," wrote ISI Group biotech analyst Mark Schoenebaum in an email to clients soon after Wednesday's announcement.
In early trading, Vertex shares were up 5% to $37.04. Merck was essentially flat at $34.85.
Merck Wednesday also released data from a second phase III study known as RESPOND-2 which tested boceprevir in patients who previously failed to respond to treatment with standard of care.
In this study, cure rates for boceprevir patients (who also received standard of care therapy) ranged from 59% to 66%. By comparison, patients who were re-treated with standard of care achieved cure rates of 21%.
Vertex is running a similar study of telaprevir in treatment-experience hepatitis C patients, with results expected in September.
Full data presentations for both telaprevir and boceprevir will be made at the American Association for the Liver Disease (AASLD) annual meeting in early November.
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