Friday, December 13, 2013

Medivir Launches New Simeprevir Combo Trial for Hep C

Medivir Launches New Simeprevir Combo Trial for Hep C
Thu, 12/12/2013 - 10:11am

Medivir AB announced the initiation of a Phase 2a trial in chronic genotype 1 hepatitis C infected patients to evaluate the efficacy, safety and tolerability of a 12-week combination therapy of simeprevir, TMC647055 and JNJ56914845, a NS5A replication complex inhibitor.
 
Approximately 40 patients will be enrolled in this open-label study to assess the efficacy, safety and tolerability of the co-administration of simeprevir, TMC647055 and two different doses of JNJ56914845 without ribavirin. The trial will evaluate genotype 1a and 1b HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 75 mg of simeprevir, 30 or 60 mg of JNJ56914845 and 450 mg of TMC647055 plus a low dose of ritonavir as a pharmacokinetic enhancer, each once daily for 12 weeks.
 
For additional information about this study, please visit www.clinicaltrials.gov.
 
Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in the USA and Canada in November. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.
 
Date: December 12, 2013
Source: Medivir
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New weapon to cure Hepatitis C

New weapon to cure Hepatitis C

Posted on: 6:07 pm, December 12, 2013, by , updated on: 10:25am, December 13, 2013 http://fox4kc.com/2013/12/12/new-weapon-to-cure-hepatitis-c/
KANSAS CITY, Mo. — Hepatitis C is a liver-destroying virus that’s most common in baby boomers. Many got it years ago from IV drug use or unsafe sex. Now there’s a new drug to cure it.
Four years ago, a physical brought bad news for Bill Barber. He had Hepatitis C, a virus that can cause liver failure, scarring and cancer. Barber tried the standard drugs which included shots of interferon with its bad side effects.
“I was exhausted. I had basically flu-like symptoms all the time,” said Barber.
And the treatment wasn’t getting rid of Hep C, so he quit. Then Barber got into a study of a pill called sofosbuvir. His doctor calls it revolutionary.
“This drug was specifically designed to go in and stop this Hepatitis C virus from replicating by stopping what’s called the RNA which is the genetic structure,” said Dr. Bradley Freilich of the Hepatitis Treatment Center at Research Medical Center’s Brookside Campus.
Dr. Freilich says depending upon the type of Hep C, the drug can eliminate the need for interferon or shorten by months the time you have to take it. Unlike interferon, sofosbuvir doesn’t have severe side effects.
“It dramatically improves the on-treatment experience that people have,” said Dr. Freilich.
Sofosbuvir has just received FDA approval. The brand name will be Sovaldi. The cure rate is better than 90 percent. That’s about twenty percent higher than with current treatment.
“It means there are people all over this country that are gonna get a chance to live,” said Barber. “They pronounced me cured. I have to credit the drug and Dr. Freilich and his staff for saving my life.”
Solvaldi will cost about $84,000 to take for three months.
The government now recommends that all baby boomers get tested for Hepatitis C since many don’t know they have it.http://fox4kc.com/2013/12/12/new-weapon-to-cure-hepatitis-c/
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Hepatitis C patients with fibrosis have more complications after TJA

Hepatitis C patients with fibrosis have more complications after TJA

Orozco F. J Arthroplasty. 2013;doi:10.1016/j.arth.2013.03.023.

  • December 12, 2013
Patients with hepatitis C patients perform similarly to control patients after elective total joint arthroplasty. However, patients with hepatic fibrosis have greater infection rates and patients with thrombocytopenia experienced more complications.
Between January 2006 and May 2011, researchers identified 72 patients with hepatitis C who underwent 77 primary total joint arthroplasty (TJA). They stratified the patients by fibrosis and thrombocytopenia and compared them to matched controls.
Researchers found showed similar outcomes between hepatitis C and control patients. The rate of infection which required irrigation and debridement was the same between patients with hepatitis C and the control group. Infection rates were higher for patients with thrombocytopenia compared to patients with hepatitis C who did not have thrombocytopenia. According to study results, fibrotic hepatitis C patients experienced a greater average decrease in hemoglobin after total knee arthroplasty, as well as greater deep infection rate and rate of cellulitis vs. the non-fibrotic hepatitis C patients.
"Liver function tests (LFT) may ascertain which hepatitis C patients are at significant risk of complication following TJA," the researchers wrote. "In our practice, liver function tests are not routinely ordered in the preoperative assessments. However, LFTs, including aminotransferase to platelet ratio index and fibrosis 4, may be useful to stage fibrosis and thrombocytopenia when liver dysfunction is suspected."
Disclosure: Ong is a paid consultant for Stryker and Smith & Nephew and receives research support from Zimmer and Baxter. Orozco is a paid consultant for and receives research support from Stryker.
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