NEW Daclatasvir Sofosbuvir w/wo RBV Compassionate Use H Risk Decomp/death <1yr

[JimmyMose]

A Multicenter Compassionate Use Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

http://clinicaltrials.gov/ct2/show/NCT02097966

Excerpts
Expanded access is currently available for this treatment.
Verified April 2014 by Bristol-Myers Squibb
Bristol-Myers Squibb
First received: March 25, 2014
Last updated: April 3, 2014

Purpose
The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without ribavirin to subjects with chronic hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.

Condition Intervention
Chronic Hepatitis C
Drug: Daclatasvir
Drug: Sofosbuvir
Drug: Ribavirin
Inclusion Criteria:

Patients chronically infected with Hepatitis C
Patients at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options
Exclusion Criteria:

Patients who are <18 years old
Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)
Patients who are pregnant
Creatinine clearance (CrCl) ≤ 30 mL/min (as estimated by Cockcroft and Gault formula)
Patients who are pregnant or Women of Child Bearing Potential who are not using required contracept

Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Austria: Agency for Health and Food Safety
Netherlands: Medicines Evaluation Board (MEB)

BTW  I searched for an update for treatment result or whatever for this person but no luck.
Doctor granted FDA emergency approval to use sofosbuvir/daclatasvir for hepatitis C transplant patient
Monday, September 16, 2013  
http://hepatitiscnewdrugs.blogspot.com/2013/09/sofosbuvir-and-daclatasvir-drug-therapy.html

Robert Gholston Jr., a 59-year-old General Motors Co. durability test driver from Troy, contracted the hepatitis C virus from a blood transfusion he received after he was hit by a car at age 9. By 2011, it had destroyed his liver, and he received a transplant at U-M Hospital. But within six months, the virus was back — and aggressively attacked his liver.

Dr. Robert Fontana, professor of internal medicine and medical director of liver transplantation at U-M Health System, obtained emergency approval from the federal Food and Drug Administration to give Gholston a treatment that combined two oral antiviral medications, sofosbuvir and daclatasvir.

[Boobert]

Gilead has no choice Sovaldi is an approved drug, this trial is all sponsered by BMS.

[Advocate1955]

Hmmm...I wonder who got BM and GILD to play nicely?

[nan535]

This is another hopeful possibility for my husband.  From above post:
"Daclatasvir in combination with Sofosbuvir with or without ribavirin to subjects with chronic hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options. "
My husband does have a therapeutic option right now. Whether he can remain on treatment or not remains to be seen.  Its really good to know he may have another option with this treatment. I will speak to his doctor about both this option and the ledipasvir option also posted on another thread.

Thank you for posting it, Jimmy.