- File Under HCV News
A new hepatitis C drug has come onto the scene — Merck’s boceprevir — after a 10-year lull in HCV therapies entering the market. The FDA’s approval of boceprevir, which will be marketed under the name Victrelis, is a victory for both Merck and HCV patients, as well as for supporters of “cocktail” drug therapies.
Boceprevir approval sets stage for blockbuster hep C cocktails
The Merck Hepatitis C Med: What The Wags Say
- I cannot stress the need to get your old records related to past HCV therapies. This will help assist us in how to best manage you on the three-drug combination.
- Get the report from your most recent liver biopsy. The degree of damage, or lack of it, will be of great value when we discuss how to best treat you.
- Have an up to date list of all your other medical condition, if this applies to you. Other conditions such as diabetes, heart disease, kidney disease, depression, or cancer will allow us to modify treatment as needed-taylored specifically to you.
- Have the names and phone numbers of all your treating physicians and health care providers. Communication with them is vital.
According to final results from the phase III REALIZE trial. Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, VA. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week. The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.
It is believed that 37 HIV-positive gay men were infected with hepatitis C and are suspected of transmitting disease to others. It has been told by the Victoria Chief Executive, Helen McNeill that HIV patients suffering from hepatitis C are at higher risk of developing liver disease.
Hepatitis C is a blood-borne virus and can be spread by using infected drug-injections or by blood transfusion. Victoria President, Paul Kidd said that bunch of cases of apparently sexually transmitted hepatitis C between HIV-positive men had been reported overseas including in Britain, France and the Netherlands.
The Health Department is now investigating the cause of the increased number of hepatitis C cases. Prevention is definitely the need of the hour. But the cause of wide spread of hepatitis C is also necessary.
Those who are already affected by the virus are being treated and those in close contact with hepatitis C and are HIV- positive are urged to seek proper medical treatment.
The latest issue of the Alimentary Pharmacology Therapeutics investigates the incidence, predictors and management of anaemia and its association with virological response in HCV/HIV coinfected persons treated with long-term pegylated interferon alfa 2a and ribavirin.
The multi-center, phase Ib/II trial will examine the safety and clinical effect of TB-403 in combination with Avastin® (bevacizumab) in patients with recurrent glioblastoma. Secondary objectives include safety, tolerability and pharmacokinetics of the combination. The trial will also include an evaluation of candidate biomarkers. The study will recruit approximately 100 patients.
The start of the phase Ib/II glioblastoma study has triggered a €4 million milestone payment to ThromboGenics and BioInvent. This is the second clinical milestone that they have received from Roche. The first milestone of €10 million was paid last year when Roche initiated an imaging study in patients with colorectal and ovarian cancer.
In March 2011, Roche initiated a phase Ib study of TB-403 in patients with primary liver cancer (hepatocellular carcinoma). This study will determine the safety, tolerability and dosage of TB-403 in combination with Nexavar® (sorafenib), as well as pharmacokinetics and pharmacodynamics. The study will recruit 60-70 patients.
Svein Mathisen, CEO of BioInvent commented, "We are very pleased that Roche has decided to take TB-403 to the next stage of its development. We believe that TB-403 could make a major contribution to the armamentarium used to treat cancer. In glioblastoma, the medical need is significant and it is our hope that this unique product candidate could improve the prospects for this patient group whose current treatment options are very limited."
Dr Patrik De Haes, CEO of ThromboGenics, added, "The start of these trials reflects a great interest in evaluating TB-403, in combination with more established oncology drugs, in a range of cancer indications. The glioblastoma study, using TB-403 together with Avastin, is designed to find better treatment options for patients with this very aggressive form of brain cancer. I believe that these studies will confirm that the further development of this novel selective anti-angiogenic antibody is warranted."
The novel mechanism of action of TB-403 represents a potentially promising cancer therapy. It is a humanized monoclonal antibody directed towards placental growth factor (PIGF), expected to act by blocking the formation of the new blood vessels that are required for tumour growth. Preclinical exploration of PIGF biology suggests a role in tumour angiogenesis and metastasis and a limited role in the maintenance of normal vasculature. This mode of action could result in therapeutic benefit with an acceptable side effect profile.
Two phase I clinical trials have found that TB-403 was well tolerated with no reported dose limiting toxicity.
BioInvent International AB
Complementary Medicine / Alternative Medicine
Colloidal Silver -FDA Issues A Warning Letter
Colloidal silver is peddled as a treatment for hepatitis C, if not a cure, according to the recent April 11th FDA warning letter sent to International Institute of Holistic Healing, Inc., Colloidal silver is recommended and sold online for treating AIDS, Cold Sores, Liver Disease, Genital Herpes, Genital Warts, and HIV.