Bristol-Myers Squibb (BMS) is developing at least the following three anti-HCV agents:
For the study reported here, researchers gave participants 12 consecutive weeks of therapy.
BMS plans to put these drugs into a single pill in the future.
The average profile of participants at the start of the study was as follows:
Researchers gave all participants daclatasvir and asunaprevir in the dose and schedule previously mentioned, and then randomly assigned them to receive one of the following two doses of BMS '325:
According to the interim analysis, the rates of SVR12 (highly suggestive of cure) were distributed as follows:
Data are incomplete for five missing participants and researchers are attempting to locate these people.
Among those without an SVR12 (11 participants) there were five breakthroughs by HCV and six others relapsed.
Five participants had mutations that conferred resistance to asunaprevir and daclatasvir and six participants had HCV that had become resistant to all three drugs.
Eight participants prematurely left the study for the following reasons:
According to researchers, '325 was well tolerated.
Common side effects reported in this study were as follows:
Abnormal blood test results
The present study and its results should be considered preliminary in nature. Still, they showcase a trio of drugs that are relatively powerful, with cure rates approaching 90%. This happened in a regimen free of interferon and ribavirin among participants with the difficult-to-treat strain of HCV -- genotype 1a.
Further studies with this combination of BMS drugs are underway. These studies have the code name Unity One (which will enroll participants without cirrhosis who have not been previously treated) and Unity Two (which will have participants with cirrhosis).
When one of the study physicians was asked about possible salvage regimens for participants who developed resistance to the study medicines, he suggested that the following strategies be considered:
Everson GT, Thuluvath PJ, Lawitz E, et al. All oral combination of daclatasvir, asunaprevir, and BSM-791325 for HCV genotype 1 infection. In: Programs and abstracts of the 21st Conference on Retroviruses and Opportunistic Infections, 3-6 March 2014, Boston, U.S. Abstract 25.
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