Trial Outcomes & Findings for An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens (NCT NCT01168856)

NCT ID: NCT01168856

Last Updated: 2016-03-11

Results Overview

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter \[IU/mL\]).

• Recruitment status: TERMINATED
• Target enrollment: 734 participants
• Primary outcome timeframe: Month 3
• Results posted on: 2016-03-11

Participant Flow

Participants from following studies were enrolled: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094].

This study was terminated early and participants discontinued due to study termination were included under reason "unspecified" in the participant flow.

Participant milestones

Measure	Resistance Monitoring Arm Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.	Sustained Virological Response (SVR) Durability Monitoring Arm Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Overall Study STARTED	176	558
Overall Study COMPLETED	158	215
Overall Study NOT COMPLETED	18	343

Reasons for withdrawal

Measure	Resistance Monitoring Arm Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.	Sustained Virological Response (SVR) Durability Monitoring Arm Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Overall Study Lost to Follow-up	4	34
Overall Study Withdrawal by Subject	6	8
Overall Study Physician Decision	2	1
Overall Study Confirmed Quantifiable HCV RNA	0	1
Overall Study Participant received anti-HCV treatment	1	0
Overall Study Death	0	2
Overall Study Other	1	291
Overall Study Protocol Violation	4	6

Baseline Characteristics

An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

Baseline characteristics by cohort

Measure	Resistance Monitoring Arm n=172 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.	SVR Durability Monitoring Arm n=552 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.	Total n=724 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 8.48 • n=5 Participants	51.0 years STANDARD_DEVIATION 10.79 • n=7 Participants	51.2 years STANDARD_DEVIATION 10.29 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	222 Participants n=7 Participants	269 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	330 Participants n=7 Participants	455 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 3.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).

Outcome measures

Measure

Resistance Monitoring Arm n=114 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3

99.1 Percentage of participants

PRIMARY outcome

Timeframe: Month 6

Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=137 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6

99.3 Percentage of participants

PRIMARY outcome

Timeframe: Month 9

Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 9.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=129 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9

99.2 Percentage of participants

PRIMARY outcome

Timeframe: Month 12

Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=123 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12

99.2 Percentage of participants

PRIMARY outcome

Timeframe: Month 18

Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 18.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=113 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18

100 Percentage of participants

PRIMARY outcome

Timeframe: Month 3

Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=113 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

HCV RNA Levels in Resistance Monitoring Arm at Month 3

3922296 IU/mL Standard Deviation 5111469

PRIMARY outcome

Timeframe: Month 6

Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=136 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

HCV RNA Levels in Resistance Monitoring Arm at Month 6

4369148 IU/mL Standard Deviation 6803658

PRIMARY outcome

Timeframe: Month 9

Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=128 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

HCV RNA Levels in Resistance Monitoring Arm at Month 9

5016299 IU/mL Standard Deviation 7235510

PRIMARY outcome

Timeframe: Month 12

Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=122 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

HCV RNA Levels in Resistance Monitoring Arm at Month 12

4955311 IU/mL Standard Deviation 6595493

PRIMARY outcome

Timeframe: Month 18

Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=113 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

HCV RNA Levels in Resistance Monitoring Arm at Month 18

4830852 IU/mL Standard Deviation 6621059

PRIMARY outcome

Timeframe: Month 3

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.

Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=111 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3

128.1 mmHg Standard Deviation 16.15

PRIMARY outcome

Timeframe: Month 6

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=134 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Systolic Blood Pressure in Resistance Monitoring Arm at Month 6

126.0 mmHg Standard Deviation 16.58

PRIMARY outcome

Timeframe: Month 9

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=128 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Systolic Blood Pressure in Resistance Monitoring Arm at Month 9

126.9 mmHg Standard Deviation 15.48

PRIMARY outcome

Timeframe: Month 12

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=122 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12

127.1 mmHg Standard Deviation 14.97

PRIMARY outcome

Timeframe: Month 18

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=114 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18

130.3 mmHg Standard Deviation 17.53

PRIMARY outcome

Timeframe: Month 3

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=111 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3

79.8 mmHg Standard Deviation 10.67

PRIMARY outcome

Timeframe: Month 6

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=134 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6

78.0 mmHg Standard Deviation 10.60

PRIMARY outcome

Timeframe: Month 9

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=128 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9

78.5 mmHg Standard Deviation 9.60

PRIMARY outcome

Timeframe: Month 12

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=122 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12

77.7 mmHg Standard Deviation 9.92

PRIMARY outcome

Timeframe: Month 18

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=114 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18

79.3 mmHg Standard Deviation 9.77

PRIMARY outcome

Timeframe: Month 3

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=111 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in Resistance Monitoring Arm at Month 3

70.6 Beats per minute Standard Deviation 9.89

PRIMARY outcome

Timeframe: Month 6

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=134 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in Resistance Monitoring Arm at Month 6

71.1 Beats per minute Standard Deviation 10.14

PRIMARY outcome

Timeframe: Month 9

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=128 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in Resistance Monitoring Arm at Month 9

70.3 Beats per minute Standard Deviation 12.08

PRIMARY outcome

Timeframe: Month 12

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=122 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in Resistance Monitoring Arm at Month 12

70.3 Beats per minute Standard Deviation 10.68

PRIMARY outcome

Timeframe: Month 18

Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=114 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in Resistance Monitoring Arm at Month 18

70.8 Beats per minute Standard Deviation 10.75

PRIMARY outcome

Timeframe: Up to 18 months

Population: Resistance monitoring population.

Percentage of participants who received any anti-HCV medication during the monitoring period was reported.

Outcome measures

Measure

Resistance Monitoring Arm n=172 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm

1.2 Percentage of participants

PRIMARY outcome

Timeframe: Month 6

Population: SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=505 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6

0.2 Percentage of participants

PRIMARY outcome

Timeframe: Month 12

Population: SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=516 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12

0 Percentage of participants

PRIMARY outcome

Timeframe: Month 24

Population: SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 24.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=416 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24

0 Percentage of participants

PRIMARY outcome

Timeframe: Month 36

Population: SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 36.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=214 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36

0 Percentage of participants

PRIMARY outcome

Timeframe: Month 6

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Measure

Resistance Monitoring Arm n=1 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6

896000 IU/mL

PRIMARY outcome

Timeframe: Month 12

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 24

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 36

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36.

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=493 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6

126.8 mmHg Standard Deviation 16.83

PRIMARY outcome

Timeframe: Month 12

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=511 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12

127.4 mmHg Standard Deviation 16.66

PRIMARY outcome

Timeframe: Month 24

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=411 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24

128.0 mmHg Standard Deviation 15.56

PRIMARY outcome

Timeframe: Month 36

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.

Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=209 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36

130.1 mmHg Standard Deviation 16.68

PRIMARY outcome

Timeframe: Month 6

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=493 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6

77.9 mmHg Standard Deviation 10.67

PRIMARY outcome

Timeframe: Month 12

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=511 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12

78.0 mmHg Standard Deviation 10.31

PRIMARY outcome

Timeframe: Month 24

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=411 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24

78.3 mmHg Standard Deviation 10.28

PRIMARY outcome

Timeframe: Month 36

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.

Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=209 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36

78.3 mmHg Standard Deviation 10.11

PRIMARY outcome

Timeframe: Month 6

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=493 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6

72.0 Beats per minute Standard Deviation 10.41

PRIMARY outcome

Timeframe: Month 12

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=511 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12

72.9 Beats per minute Standard Deviation 9.61

PRIMARY outcome

Timeframe: Month 24

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=411 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24

72.7 Beats per minute Standard Deviation 10.45

PRIMARY outcome

Timeframe: Month 36

Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.

Any abnormalities in pulse rate were reported at the discretion of principal investigator.

Outcome measures

Measure

Resistance Monitoring Arm n=209 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.

Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36

73.0 Beats per minute Standard Deviation 11.10

PRIMARY outcome

Timeframe: Month 3-18

Population: Resistance monitoring population.

Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.

Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.

Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.

Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

Outcome measures

Measure	Resistance Monitoring Arm n=162 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP22660 Category 1	3 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP22660 Category 2	0 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP22660 Category 3	1 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP27946 Category 1	1 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP27946 Category 2	3 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP27946 Category 3	1 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NV21075 Category 1	4 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NV21075 Category 2	1 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NV21075 Category 3	1 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP28266 Category 1	4 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP28266 Category 2	1 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NP28266 Category 3	6 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NV22776 Category 1	17 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NV22776 Category 2	6 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing NV22776 Category 3	6 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing PP25213 Category 1	37 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing PP25213 Category 2	11 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing PP25213 Category 3	1 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing WV21913 Category 1	33 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing WV21913 Category 2	11 participants
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing WV21913 Category 3	14 participants

PRIMARY outcome

Timeframe: Month 3-18

Population: Resistance monitoring population.

Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.

Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.

Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.

Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.

Outcome measures

Measure	Resistance Monitoring Arm n=125 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Number of Participants With DNV Resistance Status-Clonal Sequencing NP27946 Category 1	1 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NP27946 Category 2	0 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NP27946 Category 3	0 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NP22660 Category 1	3 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NP22660 Category 2	0 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NP22660 Category 3	1 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NV21075 Category 1	2 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NV21075 Category 2	2 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NV21075 Category 3	1 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NP28266 Category 1	3 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NP28266 Category 2	1 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NP28266 Category 3	4 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NV22776 Category 1	9 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NV22776 Category 2	8 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing NV22776 Category 3	6 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing PP25213 Category 1	21 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing PP25213 Category 2	16 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing PP25213 Category 3	1 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing WV21913 Category 1	25 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing WV21913 Category 2	8 participants
Number of Participants With DNV Resistance Status-Clonal Sequencing WV21913 Category 3	13 participants

PRIMARY outcome

Timeframe: Month 3-18

Population: Resistance monitoring population.

Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.

Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.

Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.

Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

Outcome measures

Measure	Resistance Monitoring Arm n=9 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing TVR study NV22779 Category 1	3 participants
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing TVR study NV22779 Category 2	1 participants
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing TVR study NV22779 Category 3	1 participants
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing BOC study NV22780 Category 1	3 participants
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing BOC study NV22780 Category 2	0 participants
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing BOC study NV22780 Category 3	1 participants

PRIMARY outcome

Timeframe: Month 3-18

Population: Resistance monitoring population.

Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.

Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.

Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.

Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.

Outcome measures

Measure	Resistance Monitoring Arm n=8 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing TVR study NV22779 Category 1	2 participants
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing TVR study NV22779 Category 2	1 participants
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing TVR study NV22779 Category 3	1 participants
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing BOC study NV22780 Category 1	1 participants
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing BOC study NV22780 Category 2	2 participants
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing BOC study NV22780 Category 3	1 participants

PRIMARY outcome

Timeframe: Month 3-18

Population: Resistance monitoring population.

Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.

Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.

Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.

Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

Outcome measures

Measure	Resistance Monitoring Arm n=11 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing NP28266 Category 1	5 participants
Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing NP28266 Category 2	3 participants
Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing NP28266 Category 3	3 participants

PRIMARY outcome

Timeframe: Month 3-18

Population: Resistance monitoring population. Here, n1=total number of participants with loss of STV resistance in NV22688 (by population sequencing). n2= total number of participants who had no STV resistance at the end of donor study they experienced a viral relapse in NV22688.

Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.

Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.

Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.

Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.

Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.

Outcome measures

Measure	Resistance Monitoring Arm n=8 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Number of Participants With STV Resistance Status-Clonal Sequencing NP28266 Category 1	1 participants
Number of Participants With STV Resistance Status-Clonal Sequencing NP28266 Category 2	4 participants
Number of Participants With STV Resistance Status-Clonal Sequencing NP28266 Category 3	1 participants
Number of Participants With STV Resistance Status-Clonal Sequencing NP28266 Category 4	2 participants

PRIMARY outcome

Timeframe: Month 18

Population: Resistance monitoring population.

Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.

Outcome measures

Measure	Resistance Monitoring Arm n=110 Participants Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 NV27779	5 participants
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 NV20536	1 participants
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 NV27780	2 participants
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 NP27946	3 participants
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 NP28266	6 participants
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 WV21913	44 participants
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 PP25213	49 participants

Adverse Events

Resistance Monitoring Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

SVR Durability Monitoring Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Resistance Monitoring Arm n=172 participants at risk Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations.	SVR Durability Monitoring Arm n=552 participants at risk Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication.
General disorders VENIPUNCTURE SITE BRUISE	0.58% 1/172 • Number of events 1 • Up to 36 Months Only adverse events (AEs) and serious adverse events (SAEs) related to protocol defined blood sampling procedures were collected.	0.00% 0/552 • Up to 36 Months Only adverse events (AEs) and serious adverse events (SAEs) related to protocol defined blood sampling procedures were collected.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER