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.