MK14-868/SURVEYOR-II

This research study is being conducted at approximately 100 research centers, and approximately 400 participants will be enrolled. Participation in this study may last up to 40 weeks (not including the screening period, which can last up to 42 days). This study is an open-label study, which means that you and the study doctor will know which drugs you are receiving. There are 2 parts in this study, with each part consisting of 2 periods, the Treatment Period and the Post-Treatment Period. Part 1 in this study will be enrolled first. After full enrollment in Part 1, available study data will be reviewed to determine whether treatment arms in part 2 may be opened for enrollment. There are 7 different treatment arms in part 1 (Arms A, B, C, D, E, F and G), and 9 different treatment arms in part 2 (Arms H, I, J, K, L, M, N, O and P). The arms differ by the combination and doses of study drugs included, as well as the length of treatment. If you are eligible to participate, you will be assigned to one of the study arms based on your genotype and/or whether or not you have cirrhosis. Neither you nor the study doctor/staff will be able to pick the study arm you are in. In part 1, if you have genotype 2, you will have an equal chance of being assigned to Arms A, B or C. If you have genotype 3, you will have an equal chance of being assigned to D, E, F or G. If you are on Arm A you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 12 weeks and 300 mg (three 100 mg tablets) of ABT-493 once daily for 12 weeks. If you are on Arm B you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 12 weeks and 200 mg (two 100 mg tablets) of ABT-493 once daily for 12 weeks. If you are on Arm C you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 12 weeks, 200 mg (two 100 mg tablets) of ABT-493 once daily for 12 weeks, and ribavirin (dose is determined by your weight). If you are on Arm D you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 12 weeks and 300 mg (three 100 mg tablets) of ABT-493 once daily for 12 weeks. If you are on Arm E you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 12 weeks and 200 mg (two 100 mg tablets) of ABT-493 once daily for 12 weeks. If you are on Arm F you will receive 120 mg (three 40 mg tablets) once daily for 12 weeks, 200 mg (two 100 mg tablets) of ABT-493 once daily for 12 weeks, and ribavirin (dose is determined by your weight). If you are on Arm G you will receive 40 mg (one 40 mg tablet) of ABT-530 once daily for 12 weeks, and 200 mg (two 100 mg tablets) of ABT-493 once daily for 12 weeks.

In part 2, if you have genotype 2, you have an equal chance of begin assigned to Arm H, I or J if more than one of the arms are opened. If only one of those arms is opened for enrollment, you will be assigned to that arm. If you are assigned to Arm H, you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 8 weeks, and 200 mg (two 100 mg tablets) of ABT-493 once daily for 8 weeks. If you are assigned to Arm I, you will receive 40 mg (one 40 mg tablet) of ABT-530 once daily for 8 weeks, and 200 mg (two 100 mg tablets) of ABT-493 once daily for 8 weeks. If you are assigned to Arm J, you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 8 weeks, and 300 mg (three 100 mg tablets) of ABT-493 once daily for 8 weeks. In part 2, if you have genotype 3 without cirrhosis, you will be assigned to Arm K or L. If you are assigned to Arm K, you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 8 weeks, and 200 mg (two 100 mg tablets) of ABT-493 once daily for 8 weeks. If you are assigned to Arm L, you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 8 weeks, and 300 mg (three 100 mg tablets) of ABT-493 once daily for 8 weeks. In part 2, if you have genotype 3 with cirrhosis, you will be assigned to Arm M, N, O or P. If you are assigned to Arm M, you will receive 80 mg (two 40 mg tablets) of ABT-530 once daily for 12 weeks, and 200 mg (two 100 mg tablets) of ABT-493 once daily for 12 weeks. If you are assigned to Arm N, you will receive 80 mg (two 40 mg tablets) of ABT-530 once daily for 12 weeks, 200 mg (two 100 mg tablets) of ABT-493 once daily for 12 weeks, and 800 mg (four 200 mg tablets) of ribavirin once daily for 12 weeks. If you are assigned to Arm O, you will receive 120 mg (three 40 mg tablets) of ABT-530 once daily for 12 weeks, and 300 mg (three 100 mg tablets) of ABT-493 once daily for 12 weeks. If you are assigned to Arm P, you will receive 120 mg (three 40 mg tablets) of ABT -530 once daily for 12 weeks, 300 mg (three 100 mg tablets) of ABT-493 once daily for 12 weeks, and 800 mg (four 200 mg tablets) of ribavirin once daily for 12 weeks.

If you are taking medications or herbal supplements that are not allowed by the protocol, you will be asked to stop taking them for 2 weeks or longer before you begin taking the assigned study drugs. This is called a washout period. There is a chance that the time period during which the study drugs are taken will be extended. This will depend on how effective the study drugs are at reducing the amount of HCV your blood. There is a chance the time period will be extended from 12 to 16 weeks or from 8 to 12 weeks, depending on the arm into which you were enrolled. The study sponsor, AbbVie will decide whether you will take your study drugs for the planned time period or the extended time period. The study doctor will tell you if your treatment period will stay the same or be extended. After completing the treatment period, you will return to the study site for an additional 24 weeks after the last dose of study drug in order to see if the HCV can still be detected in your blood. During the study you will have the following tests and procedures, including, but not limited to: medical history, a physical exam, vital signs, ECG, blood and urine tests, pregnancy tests (for women of childbearing potential), FSH test (test that determines postmenopausal status), hepatitis B and HIV test, HgbA1c test (test to see if you have diabetes, or if you do, to see how well it is controlled). There is an optional pharmacogenetic sub-study.