| Primary | Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels | The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Mean | Standard Error | log10 IU/mL | | Baseline, Day 3, and Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 | participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG004 | Genotype 6 | participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. |
| | | Title | Denominators | Categories |
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| Day 3 | | | Title | Measurements |
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| - OG000-2.02± 0.625(-3.6 to -0.3)
- OG0010.16± 0.263(-0.7 to 1.8)
- OG002-3.43± 0.167(-3.9 to -2.6)
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| Secondary | Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period | The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period. | Intent-to-treat (ITT) Population- all randomized subjects who received at least 1 dose of study medication (TMC435) | Posted | | Number | | Participants | | Baseline, Day 3, Day 5 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 |
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| Secondary | Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period | The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period. | Intent-to-treat (ITT) Population - all randomized subjects who received at least 1 dose of study medication (TMC435) | Posted | | Number | | Participants | | Baseline, Day 3, Day 5 and Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. |
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| Secondary | Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period | The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Number | | Participants | | During the 7-day of TMC435 treatment period | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. |
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| Secondary | Predose Plasma Concentration (C0h) of TMC435 | The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | ng/mL | | Predose on Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 | participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. |
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| Secondary | Minimum Plasma Concentration (Cmin) of TMC435 | The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | ng/mL | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 | participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. |
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| Secondary | Maximum Plasma Concentration (Cmax) of TMC435 | The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | ng/mL | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 | |
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| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435 | The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | hours | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 | |
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| Secondary | Average Steady-State Plasma Concentration (Css,av) of TMC435 | The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | ng/mL | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 | |
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| Secondary | Fluctuation Index (FI) of TMC435 | The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | % fluctuation | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 |
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| Secondary | Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435 | The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection. | Intent-to-treat (ITT) population - as all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | ng*h/mL | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435 | The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | ng*h/mL | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | |
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| Secondary | Elimination Rate Constant of TMC435 | In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | 1/hour | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 | Genotype 5 |
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| Secondary | Terminal Elimination Half-life (t1/2,Term) of TMC435 | The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection. The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435). | Posted | | Median | Full Range | hours | | Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7 | | | | ID | Title | Description |
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| OG000 | Genotype 2 | Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG001 | Genotype 3 | Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG002 | Genotype 4 | Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days. | | OG003 |
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