| Primary | Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm 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]). | 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. | Posted | | Number | | Percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | 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. | Posted | | Number | | Percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | 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. | Posted | | Number | | Percentage of participants | | Month 9 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | 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. | Posted | | Number | | Percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | 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. | Posted | | Number | | Percentage of participants | | Month 18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | HCV RNA Levels in Resistance Monitoring Arm at Month 3 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3. | Posted | | Mean | Standard Deviation | IU/mL | | Month 3 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | HCV RNA Levels in Resistance Monitoring Arm at Month 6 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6. | Posted | | Mean | Standard Deviation | IU/mL | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | HCV RNA Levels in Resistance Monitoring Arm at Month 9 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9. | Posted | | Mean | Standard Deviation | IU/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | HCV RNA Levels in Resistance Monitoring Arm at Month 12 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12. | Posted | | Mean | Standard Deviation | IU/mL | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | HCV RNA Levels in Resistance Monitoring Arm at Month 18 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18. | Posted | | Mean | Standard Deviation | IU/mL | | Month 18 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3 | Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3. | Posted | | Mean | Standard Deviation | mmHg | | Month 3 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Systolic Blood Pressure in Resistance Monitoring Arm at Month 6 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6. | Posted | | Mean | Standard Deviation | mmHg | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Systolic Blood Pressure in Resistance Monitoring Arm at Month 9 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9. | Posted | | Mean | Standard Deviation | mmHg | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12. | Posted | | Mean | Standard Deviation | mmHg | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18. | Posted | | Mean | Standard Deviation | mmHg | | Month 18 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3. | Posted | | Mean | Standard Deviation | mmHg | | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6. | Posted | | Mean | Standard Deviation | mmHg | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9. | Posted | | Mean | Standard Deviation | mmHg | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12. | Posted | | Mean | Standard Deviation | mmHg | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18. | Posted | | Mean | Standard Deviation | mmHg | | Month 18 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Mean Pulse Rate in Resistance Monitoring Arm at Month 3 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | Mean Pulse Rate in Resistance Monitoring Arm at Month 6 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | Mean Pulse Rate in Resistance Monitoring Arm at Month 9 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | Mean Pulse Rate in Resistance Monitoring Arm at Month 12 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Resistance Monitoring Arm | 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. |
| |
| Primary | Mean Pulse Rate in Resistance Monitoring Arm at Month 18 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm | Percentage of participants who received any anti-HCV medication during the monitoring period was reported. | Resistance monitoring population. | Posted | | Number | | Percentage of participants | | Up to 18 months | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | 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. |
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| Primary | Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | 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. | Posted | | Number | | Percentage of participants | | Month 6 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | 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. | Posted | | Number | | Percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. |
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| Primary | Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | 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. | Posted | | Number | | Percentage of participants | | Month 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. |
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| Primary | Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | 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. | Posted | | Number | | Percentage of participants | | Month 36 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. |
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| Primary | Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6. | Posted | | Mean | Standard Deviation | IU/mL | | Month 6 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12. | Posted | | | | | | Month 12 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24. | Posted | | | | | | Month 24 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). | SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36. | Posted | | | | | | Month 36 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6. | Posted | | Mean | Standard Deviation | mmHg | | Month 6 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12. | Posted | | Mean | Standard Deviation | mmHg | | Month 12 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24. | Posted | | Mean | Standard Deviation | mmHg | | Month 24 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36. | Posted | | Mean | Standard Deviation | mmHg | | Month 36 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6. | Posted | | Mean | Standard Deviation | mmHg | | Month 6 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12. | Posted | | Mean | Standard Deviation | mmHg | | Month 12 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24. | Posted | | Mean | Standard Deviation | mmHg | | Month 24 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36. | Posted | | Mean | Standard Deviation | mmHg | | Month 36 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 6 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 12 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 24 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. | SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36. | Posted | | Mean | Standard Deviation | Beats per minute | | Month 36 | | | | ID | Title | Description |
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| OG000 | 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 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. |
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| Primary | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | 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. | Resistance monitoring population. | Posted | | Number | | participants | | Month 3-18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months. |
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| Primary | Number of Participants With DNV Resistance Status-Clonal Sequencing | 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. | Resistance monitoring population. | Posted | | Number | | participants | | Month 3-18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months. |
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| Primary | Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing | 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. | Resistance monitoring population. | Posted | | Number | | participants | | Month 3-18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months. |
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| Primary | Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing | 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. | Resistance monitoring population. | Posted | | Number | | participants | | Month 3-18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months. |
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| Primary | Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing | 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. | Resistance monitoring population. | Posted | | Number | | participants | | Month 3-18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | Participants enrolled into this arm were those with HCV infection who participated in the following donor protocol: NP28266 [NCT01628094]. Patients had developed STV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months. |
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| Primary | Number of Participants With STV Resistance Status-Clonal Sequencing | 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. | 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. | Posted | | Number | | participants | | Month 3-18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months. |
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| Primary | Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol. | Resistance monitoring population. | Posted | | Number | | participants | | Month 18 | | | | ID | Title | Description |
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| OG000 | Resistance Monitoring Arm | Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV20536 [NCT00869661], WV21913 [NCT01331850], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], NP28266 [NCT01628094]. None of the enrolled patients had developed MCB-associated resistant mutation(s) in donor protocol. Participants were monitored up to 18 months. |
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