| Primary | Area Under the Drug Plasma Concentration-Time Curve From Start of Dosing to Time of the Last Quantifiable Sample (AUC0-last) of Uprifosbuvir | AUC0-last is a measure of the mean plasma drug concentration from time of dosing to the last quantifiable sample. The AUC0-last for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0005.34(3.55 to 8.05)
- OG0018.02(5.32 to 12.1)
- OG0023.74(2.48 to 5.63)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Geometric least-squares mean ratio | 1.43 | | | 2-Sided | 90 | 0.89 | 2.31 | | | | | Other | | | | | | | | |
|
| Primary | Area Under the Drug Plasma Concentration-Time Curve From Start of Dosing to Infinity (AUC0-inf) of Uprifosbuvir | AUC0-inf is a measure of the mean plasma drug concentration from time of dosing to infinity. The AUC0-inf for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | Area Under the Plasma Drug Concentration-Time Curve From Start of Dosing to 24 Hours Post-Dose (AUC0-24hr) of Uprifosbuvir | AUC0-24hr is a measure of the mean plasma drug concentration from time of dosing to 24 hours post-dose. The AUC0-24hr for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | Maximum Plasma Drug Concentration (Cmax) of Uprifosbuvir | Cmax is the maximum observed plasma drug concentration after dosing. The Cmax for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | nM | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | Plasma Drug Concentration at 24 Hours (C24hr) of Uprifosbuvir | C24hr is a measure of plasma drug concentration 24 hours after dosing. The C24hr of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Median | Full Range | nM | | 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
| |
| Primary | Time to Reach Cmax (Tmax) of Uprifosbuvir | Tmax is the time required to reach maximum plasma drug concentration (i.e., Cmax). The Tmax for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Median | Full Range | hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
| |
| Primary | Apparent Terminal Half-Life (t1/2) of Uprifosbuvir | t1/2 is a measure of how long it takes to clear 50% of drug after reaching Cmax. The t1/2 for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | Apparent Total Clearance From Plasma After Oral Administration (CL/F) of Uprifosbuvir | CL/F is a measure of the apparent rate at which drug is removed from the body via renal, hepatic, and other clearance pathways after oral administration. The CL/F of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of Uprifosbuvir | Vz/F is the apparent volume of distribution during the terminal phase after non-intravenous administration. The Vz/F of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L | | Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | AUC0-last of Uprifosbuvir Metabolite M5 | AUC0-last is a measure of the mean plasma drug concentration from time of dosing to the last quantifiable sample. The AUC0-last for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | AUC0-inf of Uprifosbuvir Metabolite M5 | AUC0-inf is a measure of the mean plasma drug concentration from time of dosing to infinity. The AUC0-inf for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | AUC0-24hr of Uprifosbuvir Metabolite M5 | AUC0-24hr is a measure of the mean plasma drug concentration from time of dosing to 24 hours post-dose. The AUC0-24hr for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | Cmax of Uprifosbuvir Metabolite M5 | Cmax is the maximum observed plasma drug concentration after dosing. The Cmax for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | nM | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | C24hr of Uprifosbuvir Metabolite M5 | C24hr is a measure of plasma drug concentration 24 hours after dosing. The C24hr of the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | nM | | 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
| |
| Primary | Lag Time (Tlag) for Uprifosbuvir Metabolite M5 | Tlag is a measure of the time delay between drug administration and the onset of absorption, where onset of absorption is defined as "the time point prior to the first observed/measured non-zero plasma concentration". The Tlag of the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm (in this study Tlag was only calculated for the M5 uprifosbuvir metabolite). | All participants are included in the analysis. | Posted | | Median | Full Range | hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | Tmax of Uprifosbuvir Metabolite M5 | Tmax is the time required to reach maximum plasma drug concentration (i.e., Cmax). The Tmax for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Median | Full Range | hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
| |
| Primary | Apparent t1/2 of Uprifosbuvir Metabolite M5 | Apparent t1/2 is a measure of how long it takes to clear 50% of drug after reaching Cmax. The t1/2 for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | AUC0-last of Uprifosbuvir Metabolite M6 | AUC0-last is a measure of the mean plasma drug concentration from time of dosing to the last quantifiable sample. The AUC0-last for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | AUC0-inf of Uprifosbuvir Metabolite M6 | AUC0-inf is a measure of the mean plasma drug concentration from time of dosing to infinity. The AUC0-inf for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | AUC0-24hr of Uprifosbuvir Metabolite M6 | AUC0-24hr is a measure of the mean plasma drug concentration from time of dosing to 24 hours post-dose. The AUC0-24hr for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | Cmax of Uprifosbuvir Metabolite M6 | Cmax is the maximum observed plasma drug concentration after dosing. The Cmax for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | nM | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
|
| Primary | C24hr of Uprifosbuvir Metabolite M6 | C24hr is a measure of plasma drug concentration 24 hours after dosing. The C24hr of the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | nM | | 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | Tmax of Uprifosbuvir Metabolite M6 | Tmax is the time required to reach maximum plasma drug concentration (i.e., Cmax). The Tmax for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Median | Full Range | hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | Apparent t1/2 of Uprifosbuvir Metabolite M6 | Apparent t1/2 is a measure of how long it takes to clear 50% of drug after reaching Cmax. The t1/2 for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | AUC0-last of Ruzasvir | AUC0-last is a measure of the mean plasma drug concentration from time of dosing to the last quantifiable sample. The AUC0-last for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | AUC0-inf of Ruzasvir | AUC0-inf is a measure of the mean plasma drug concentration from time of dosing to infinity. The AUC0-inf for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | AUC0-24hr of Ruzasvir | AUC0-24hr is a measure of the mean plasma drug concentration from time of dosing to 24 hours post-dose. The AUC0-24hr for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | Maximum Plasma Drug Concentration (Cmax) of Ruzasvir | Cmax is the maximum observed plasma drug concentration after dosing. The Cmax for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | nM | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | C24hr of Ruzasvir | C24hr is a measure of plasma drug concentration 24 hours after dosing. The C24hr of ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | nM | | 24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | Tmax of Ruzasvir | Tmax is the time required to reach maximum plasma drug concentration (i.e., Cmax). The Tmax of ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Median | Full Range | hr | | Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | Apparent t1/2 of Ruzasvir | Apparent t1/2 is a measure of how long it takes to clear 50% of drug after reaching Cmax. The t1/2 for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | CL/F of Ruzasvir | CL/F is a measure of the apparent rate at which drug is removed from the body via renal, hepatic, and other clearance pathways after oral administration. The CL/F of ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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| Primary | Vz/F of Ruzasvir | Vz/F is the apparent volume of distribution during the terminal phase after non-intravenous administration. The Vz/F of ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm. | All participants are included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L | | Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Moderate HI Participants | Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG001 | Severe HI Participants | Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. | | OG002 | Healthy Participants | Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. |
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