Study Design and ResultsThis open-label, two-part Phase II study is designed to evaluate the safety and antiviral activity of the investigational hepatitis C treatment regimen of DCV, ASV and BMS-791325 in treatment-naïve patients with genotype 1 chronic hepatitis C infection. The primary endpoint of the study is viral load below the lower limit of quantitation (LLOQ; HCV RNA <25 IU/mL) at 12 weeks post-treatment (SVR 12). Data presented at AASLD are from an interim analysis of Part 1 of the study. In Part 1, 32 patients were randomized 1:1 (n=16/arm) into two groups.
- Group 1: 24 weeks of treatment with DCV 60 mg QD, ASV 200 mg BID, BMS-791325 75 mg BID
- Group 2: 12 weeks of treatment with DCV 60 mg QD, ASV 200 mg BID, BMS-791325 75 mg BID
- Group 1 (24 week treatment): 94% (15/16) achieved undetectable viral load by the end of treatment and sustained through SVR 4. Two patients discontinued study drugs prior to the protocol-defined last treatment visit, one due to inability to comply with study procedures (poor venous access) who achieved SVR 4, and one withdrew consent and is lost to follow up.
- Group 2 (12 week treatment): 100% (16/16) achieved undetectable viral load by the end of treatment and 94% (15/16) achieved SVR 12. The remaining one patient was lost to follow-up after completing treatment but did return approximately 24 weeks post treatment and in preliminary data, has achieved SVR 24. One patient discontinued study drugs prior to the protocol-defined last treatment visit (due to poor/non-compliance) and achieved SVR 12.
- Viral load declined rapidly in both groups and was below LLOQ in all patients (32/32) by week 4.
- There was no viral breakthrough during treatment and no post-treatment relapse.
No Grade 3-4 elevations in liver enzymes (ALT/AST) or bilirubin were observed. One grade 3 AE (headache) resolved after seven days with continued study treatment and one grade 3–4 laboratory abnormality (lymphopenia) was recorded in Group 2 at a single study visit concomitant with influenza. All other AEs were grade 1 or 2.About Bristol-Myers Squibb’s Commitment to Liver Disease Bristol-Myers Squibb is studying a portfolio of compounds that aims to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. The Company’s hepatitis C pipeline includes compounds with different mechanisms of action, pursuing both biologics as well as small molecule direct-acting antivirals. These compounds are being studied as part of multiple treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies. Daclatasvir is an NS5A replication complex inhibitor that is being extensively studied as a key component of potential DAA-based hepatitis C treatment regimens. Studied in more than 3,000 patients to date, daclatasvir is in Phase III development. Asunaprevir is an NS3 protease inhibitor in Phase III development for hepatitis C as a component of daclatasvir-based treatment regimens, and has been studied in more than 1,200 patients to date. BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, currently in Phase II development for hepatitis C as a component of daclatasvir-based treatment regimens. About Hepatitis C Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C, with genotype 1 being the most prevalent genotype. Up to 90 percent of those infected with hepatitis C will not clear the virus and will become chronically infected. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may progress to liver cancer.
About Bristol-Myers SquibbBristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews. Bristol-Myers Squibb Forward Looking Statement This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that clinical trials of these compounds will support regulatory filings, or that the compounds will receive regulatory approvals or, if approved, that they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2011, in our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.