BOSTON – In patients with chronic hepatitis C virus infections and compensated cirrhosis, a combination of a direct-acting antiviral agent, pegylated interferon, and ribavirin produced high on-treatment virologic response rates, but at the cost of significantly increased toxicities in an interim analysis of a French multicenter trial looking at the safety of the regimen.
Although the efficacy of direct-acting antiviral regimens involving the protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) combined with pegylated interferon alfa-2a or -2b in combination with ribavirin (PEG-IFN/RBV) in cirrhotic nonresponders to prior therapy was good , their safety was “poor,” according to Dr. Christophe Hézode of the Hôpital Henri Mondor in Créteil, France.
The race to develop a hepatitis C pill is one of the most dramatic in
the pharmaceutical industry. Almost no month goes by without surprises,
good as well as bad.
Incivek from Vertex (VRTX) and Victrelis from Merck (MRK), revolutionary direct-acting
antivirals approved just last year, are already considered antiquated
because they require interferon injections with unwanted side effects.
BOSTON – Call it interferon 3.0. An
investigational form of the immunomodulator, known as interferon-lambda,
appeared to be effective against chronic hepatitis C virus infections,
but had fewer side effects than interferon alfa, in two separate
In a phase IIb study, ribavirin plus pegylated
interferon-lambda-1a (IFN-L/RBV) was comparable in efficacy to ribavirin
plus pegylated interferon alfa-2a (PEG-IFN/RBV) in treatment-naive
patients with hepatitis C (HCV) genotype 1 or 4 viral infections, Dr.
Andrew J. Muir reported at the annual meeting of the American
Association for the Study of Liver Diseases.
An all-oral regimen of
telaprevir, VX-222 and ribavirin for 12 weeks was generally well-tolerated and
produced sustained virological response in approximately 70% of previously
untreated chronic hepatitis C patients, according to findings from the ZENITH
study presented at the 63rd Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD) last month in Boston.
recent approval of the first direct-acting antiviral drugs for hepatitis C has brought
about a new era of treatment, but many patients and providers are awaiting
all-oral regimens without interferon and its difficult side effects.
ZENITH trial evaluated the safety, tolerability, and antiviral activity of
telaprevir (Incivo / Incivek) –
one of the HCV protease inhibitors approved last year –
plus the experimental non-nucleoside HCV polymerase inhibitor VX-222, both
developed by Vertex Pharmaceuticals.
BOSTON — Patients with chronic hepatitis C may be at greater risk for
depression, according to data presented at The Liver Meeting 2012.
Researchers assessed data on 15,263 adult patients collected from the
National Health and Nutrition Examination Survey between 2005 and 2010.
All participants had chronic hepatitis C or chronic hepatitis B;
alcohol-related liver disease (ALD), defined as elevated
aminotransferases and daily alcohol consumption of more than 20 g; or
nonalcoholic fatty liver disease (NAFLD), defined as elevated
aminotransferases without the presence of excessive alcohol consumption
or other liver diseases. Depression was evaluated according to patient
responses to the PHQ-9 survey.
“Based on the results we found, the only association [with depression]
is with chronic HCV,” Mir said, noting that this cross-sectional study
allowed for the attribution of associations,
The hepatitis C (HCV) market was white hot in 2011 and through the
beginning of 2012, but investors have gotten the message that new HCV
drugs are not going to rival cancer and cardiovascular drugs for
profits. In this interview with The Life Sciences Report,
analyst John Tucker of Sagient Research discusses a handful of stocks
that could benefit from new, patient-friendly HCV therapies with enough
revenue to propel shares upward.
A new study conducted by Spanish researchers has sounded the alarm that
rates of liver cancer are rising dramatically among people with HIV,
solely as a result of coinfection with either hepatitis B, C or both,
aidsmap reports. Published in the online edition of Clinical Infectious
Diseases, the analysis of records from 18 hospitals in Spain concerning
HIV patients between 1999 to 2010 offered a grim portrait: Those with
hepatocellular carcinoma (HCC, the most common liver cancer) were often
diagnosed late and had generally poor prognoses; and less than a third
of the liver cancer patients coinfected with the hepatitis C virus (HCV)
ever received antiviral treatment.
BOSTON – Liver transplant recipients with
hepatitis C virus infection who underwent triple-drug therapy achieved a
high extended rapid virologic response rate but often contended with
treatment complications in a retrospective multicenter cohort study.
The extended rapid virologic response (eRVR) rate
seen in 57% of patients was “encouraging, given a very difficult-to-cure
population,” Dr. James R. Burton, Jr., said at the annual meeting of
the American Association for the Study of Liver Diseases. He noted,
however, that it’s not clear if the encouraging eRVR rate will predict
sustained virologic response (SVR) as it does in non-liver transplant