Of the seven patients who were not in the per-protocol population, four achieved SVR12 and three discontinued early for reasons other than adverse experiences or virologic failure.Among the entire study population of 65 patients, one patient (1.5%) experienced a relapse with detectable HCV RNA at follow-up week 4 and 12. TABLE Primary Analysis Population: Per Protocol*
|Arm||Regimen||N||GT1a / GT1b||SVR4||SVR12 #|
|1||MK-5172 (100 mg) + MK-8742 (20 mg) + ribavirin||22||76% / 24%||22/22 (100%)||21/21 (100%)|
|2||MK-5172 (100 mg) + MK-8742 (50 mg) + ribavirin||24||70% / 30%||23/24 (96%)||23/24 (96%)|
|3||MK-5172 (100 mg) + MK-8742 (50 mg)||12||0% / 100%||12/12(100%)||11/11 (100%)|
| * Seven Patients were excluded from the Per Protocol Population |
The C-WORTHY trial has been expanded to evaluate the safety and efficacy of MK-5172 and MK-8742, with or without RBV, in difficult-to-cure HCV genotype 1-infected patient populations. Approximately 400 additional HCV genotype 1-infected patients have been enrolled in this trial. The expanded C-WORTHY study is testing:
- 8 week regimen of MK-5172/MK-8742 + RBV in treatment naïve non-cirrhotic patients
- 12 week regimen of MK-5172/MK-8742 without RBV in treatment-naïve non-cirrhotic patients
- 12 week regimens (MK-5172/MK-8742 with or without RBV) among HIV co-infected patients
- 12 or 18 week regimens (MK-5172/MK-8742 with or without RBV) in patients with cirrhosis
- 12 or 18 week regimens (MK-5172/MK-8742 with or without RBV) in patients who had failed to respond to prior peginterferon and RBV therapy (“null responders”).
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov).