Breakthrough Designation Granted to Bristol-Myers Squibb's Investigational Combination Treatment for Type-1b Chronic Hepatitis C Infection

A combination of daclatasvir and asunaprevir for type-1b hepatitis C virus infection has received breakthrough therapy designation by the FDA, meaning a faster path to approval.

A combination of daclatasvir and asunaprevir for type-1b hepatitis C virus infection has received breakthrough therapy designation by the FDA, meaning a faster path to approval.

The FDA has granted breakthrough therapy designation to a combination of daclatasvir (DCV) and asunaprevir (ASV) in development by Bristol-Myers Squibb (BMS). The FDA’s decision reflects positive preliminary results with the combination in patients with genotype 1b chronic hepatitis C infection (HCV).1

To promote innovation, the breakthrough therapies designation was created on July 9, 2012, through passage of the Food and Drug Administration Safety and Innovation Act. Breakthrough therapies treat a serious or life-threatening disease, and have the support of preliminary clinical evidence indicating that the drugs may represent a meaningful improvement over currently available treatments. Drugs designated as breakthrough therapies also undergo an expedited review process.2

Although BMS announced that results of the US trial would soon be released at a scientific forum, the DCV/ASV combination has already undergone phase-3 trials in Japanese patients with genotype 1b HCV who failed to achieve cure with interferon or were intolerant to or ineligible for interferon therapy.3

Results of the study in Japan showed that the combination led to sustained viral response 24 weeks after the end of treatment (SVR24) in approximately 85% of patients with type-1b chronic HCV infection in a 222-person trial. Patients enrolled in the study were slightly older, with a higher proportion of women, than the patient populations typically treated in similar trials conducted in the United States and Europe. More than one-third of patients in the trial (40%) were older than 65 years.3

In the Japanese trial, patients ineligible for or intolerant to interferon treatment had an 87% rate of SVR24, while patients who had not responded to interferon-based treatment had a slightly lower response rate, at 81%. Patients with cirrhosis responded unusually well, with a 91% rate of SVR24, compared with an 84% response rate in patients without cirrhosis. However, it is important to note that asunaprevir does not show efficacy against genotype-2 or -3 HCV infection, and the DCV/ASV combination is less effective against type-1a HCV infection than type-1b HCV infection.3

Patients with type-1b chronic HCV infection may be interested in enrolling in a 3-year clinical trial with the DCV/ASV combination treatment from BMS. For more information on the trial, which is currently recruiting participants, please visit http://clinicaltrials.gov/ct2/show/NCT01492504.4

References

  • Bristol-Myers Squibb receives U.S. FDA breakthrough therapy designation for all-oral daclatasvir dual investigational regimen for chronic hepatitis C. Bristol-Myers Squibb website. http://phx.corporate-ir.net/phoenix.zhtml?c=106664&p=irol-newsArticle&ID=1902689&highlight=. Accessed February 2014.
  • Fact sheet: breakthrough therapies. FDA website. www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm329491.htm. Accessed February 2014.
  • AASLD 2013: daclatasvir + asunaprevir cures 85% of genotype 1b hepatitis C patients in Japanese study. HIVandHepatitis.com website. www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4404-aasld-2013-daclatasvir-asunaprevir-cures-85-of-genotype-1b-hepatitis-c-patients-in-japanese-study. Accessed February 2014.
  • Three-year follow-up study of subjects who participated in a previous asunaprevir (BMS-650032) and/or daclatasvir (BMS-790052) chronic hepatitis C clinical trial. ClinicalTrials.gov website. http://clinicaltrials.gov/ct2/show/NCT01492504. Accessed February 2014.