Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)

AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related.

Time frame: Treatment period plus the first 14 days of follow-up (up to 14 weeks)

Population: All-Subjects-As-Treated (ASAT) Population; all randomized participants who received ≥ 1 dose of study therapy. The percentage of participants with specific AEs and accompanying 95% CI were reported for each treatment arm.

SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) \<25 IU/mL, either target detected but unquantifiable (TD\[u\]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population.

Time frame: 12 weeks after end of all therapy (Study Week 24)

Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy with no important protocol deviations) with available data.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS).

Time frame: From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)

Population: FAS; all randomized participants who received ≥1 dose of study therapy. Participants in the FAS not achieving TND were censored from the analysis.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels \<25 IU/ml (either TD\[u\] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.

Time frame: From TW 2 through TW 12 (up to 12 weeks)

Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.

SVR24 was defined as HCV RNA \<25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population.

Time frame: 24 weeks after end of all therapy (Study Week 36)

Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.

SVR4 was defined as HCV RNA \<25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population.

Time frame: 4 weeks after end of all therapy (Study Week 16)

Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.

Time frame: From TW 2 through TW 12 (up to 12 weeks)

Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.