Sunday, April 28, 2013

Hepatitis C - Will physicians go off label, and prescribe Sofosbuvir and Daclatasvir?

Hello folks,
In short, as most of you know Daclatasvir is a Bristol-Myers-Squibb drug - Sofosbuvir is Gilead's drug. The controversy began when Gilead refused to move forward with Phase III trials testing Bristol-Myers drug with their own.

The HCV community was in an uproar, as you may remember one patient refused to stand by in silence, soon an online petition was implemented by Margaret Dudley urging Gilead and Bristol-Myers to collaborate on the promising new treatment for hepatitis C.

The two articles below emphasize the highly successful HCV drug regimen; hinting at an off label use after both drugs are FDA approved, the backstory and results presented Saturday at the liver conference;

April 27
Bloomburg article by Simeon Bennett: Gilead-Bristol Hepatitis C Drug Combo Cures All in Study on the highly effective combination
In a study among 41 patients of Gilead’s sofosbuvir combined with Bristol’s daclatasvir, with or without the generic antiviral ribavirin, 40 had undetectable virus in their blood 12 weeks after finishing six months of treatment, according to results presented today at a meeting in Amsterdam. The other patient didn’t turn up to the last appointment and was later found to be virus-clear. Patients in both groups had failed prior treatment with either Vertex Pharmaceuticals Inc. (VRTX)’s Incivek or Merck & Co. (MRK)’s Victrelis.
Still, doctors may be tempted to prescribe the Gilead- Bristol combo “off-label” once both drugs are approved, said Mark Thursz, secretary-general of the European liver association.  
Prescribing the two drugs as an off-label combination may be too expensive because they’ll probably have high prices as individual therapies whereas Gilead’s cocktail may be cheaper, he said.

Off-label use may also be dangerous, said Jean-Michel Pawlotsky, a professor of medicine at the University of Paris- Est.

“We don’t have enough safety data,” Pawlotsky said in an interview. “If a doctor does that and there’s a major accident, the doctor is liable. It’s dangerous but I know that people will do it.”

Read the full article : Gilead-Bristol Hepatitis C Drug Combo Cures 100% in Study

April 28
The controversy continues over at FierceBiotech as well, in an article written today by John Carroll: Shunned Gilead/Bristol-Myers hep C combo may be too good for docs to ignore.
The author writes;

What if you had a great combination of rival drugs that worked in 100% of patients, but one of the companies involved refused to participate in the trials needed for an approval? If you're Gilead, the answer is to continue to ignore compelling data, shun the competitor drug and stay focused on an in-house combo that could deliver a big segment of the market. But some patients and doctors appear willing to consider taking matters into their own hands.
Read the entire article here...

Conference Coverage @ HIVand Hepatitis

EASL 2013: Daclatasvir + Sofosbuvir Offers Rescue Therapy after Current Standard of Care
Published on Sunday, 28 April 2013 00:00
Written by Liz Highleyman
An interferon-free regimen of daclatasvir plus sofosbuvir, with or without ribavirin, cured all previously treated hepatitis C patients who did not respond to interferon-based triple therapy using the approved HCV protease inhibitors boceprevir (Victrelis) or telaprevir (Incivek), according to a report presented at the EASL International Liver Congress (EASL 2013) this week in Amsterdam
Continue reading...
Conference Coverage @ NATAP

Coverage @Clinical Care Options
CCO's independent conference coverage
Daclatasvir Plus Sofosbuvir ± Ribavirin Achieves 95% to 100% SVR12 Rate in Patients With Previous Virologic Failure on Telaprevir or Boceprevir
Virologic response rates to all-oral, once-daily 24-week regimen unaffected by baseline NS3 variants conferring protease inhibitor resistance.
Date Posted: 4/28/2013

No comments:

Post a Comment