Added the deleobuvir name for BI 207127. Phase of trial changed from Ib/IIb to IIb/III. Amendment was based on the trial 1241.25 preliminary results suggesting a QTc increase and, regardless of its methodological shortcomings, increased frequency of electrocardiogram measurements. Removed ondansetron as a recommended treatment of vomiting because of its QTc prolongation potential per updated List of Restricted and Use with Caution Concomitant Drugs, Version 3.0 in investigator site file. Added clarification that additional ECGs could have been collected by the investigator for safety reasons. Added that electrocardiograms could have been sent to the electrocardiogram laboratory to undergo central assessment.Added clarification that serum pregnancy tests would be performed for females of childbearing potential only at all marked visits on the Flow Chart. Added clarification that urine pregnancy tests would be performed at Visit 2 for all females as part of eligibility assessment.Added that DRESS had been reported in he faldaprevir program at 120 and 240 mg QD doses. Referred to Appendix 10.2.3 for treatment discontinuation in case of potentially life-threatening skin reactions.Added DRESS to potentially life threatening reaction examples. Added that patients needed to be monitored for the appearance of systemic symptoms. Added clarification of definitions of treatment experienced patients eligible to enter the trial. Clarified exclusion of patients that had taken direct acting antiviral agent. Clarified that Child-Pugh C patients were to be excluded Modification of entry criteria to be more adapted to the Child-Pugh B patient population. Added clarification for treatment discontinuation if a female patient became pregnant and added guidance if a female partner of a male patient became pregnant.

Potential risk of agranulocytosis/neutropenia was added. Deleted text that referenced dose reduction instructions. Added treatment discontinuation if absolute neutrophil count was ≤ 500 cells/mm3.To record all SAEs with onset date after 28 days post-end-of-treatment (EOT) until end-of-observation (EOO), to define residual effect period, and to clarify SAE reporting requirements after trial completion. Updated text on the management of gastrointestinal events.

Removed Arm 3 and Cohort B from the trial design as well as all supporting text intended only for these treatment groups. Week 16 intensive pharmacokinetic (PK) sampling and analysis removed. PK parameters edited. Protein binding sampling and analysis removed. Follow up period shortened from 96 to 12 weeks. Analyses for all endpoints to be done after last patient last visit. Revised wording on reporting pregnancy for a female partner of a male patient.