Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ] . FDA label
Also known as Elbasvir (EBR)
Elbasvir · 2 trials · 2 indications
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 to determine the AUC0-24hr of elbasvir.
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the Cmax of Elbasvir.
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24, to determine the concentration of elbasvir at Hour 24 was determined.
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the maximum concentration (Cmax) of elbasvir. The time to reach Cmax (Tmax) was determined.
Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the t1/2 of elbasvir.
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded.
| Arm | Type | Description |
|---|---|---|
| Mild Hepatic Insufficiency | EXPERIMENTAL | Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale |
| Moderate Hepatic Insufficiency | EXPERIMENTAL | Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale |
| Severe Hepatic Insufficiency | EXPERIMENTAL | Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale |
| Healthy Participants | EXPERIMENTAL | Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight |
| GT1 HCV 10-mg Elbasvir (Panel A) | EXPERIMENTAL | Participants with GT1 HCV receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| GTI HCV 50-g Elbasvir (Panel B) | EXPERIMENTAL | Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| GT1 HCV 5-mg Elbavir (Panel C) | EXPERIMENTAL | Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| GT1 HCV 200-mg Elbasvir (Panel D) | EXPERIMENTAL | Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. |
| GT3 HCV 10-mg Elbasvir (Panel E) | EXPERIMENTAL | Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| GT3 HCV 50-mg Elbasvir (Panel F) | EXPERIMENTAL | Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| GT3 HCV 100-mg Elbasvir (Panel G) | EXPERIMENTAL | Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| GT3 HCV 200-mg Elbasvir (Panel H) | EXPERIMENTAL | Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. |
| GT1a HCV 10-mg Elbasvir (Panel I) | EXPERIMENTAL | Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study. |
| GT1a HCV 50-mg Elbasvir (Panel J) | EXPERIMENTAL | Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study. |
| Name | Type | Description |
|---|---|---|
| Elbasvir | DRUG | - |
| Placebo | DRUG | Dose-matched placebo tablets were administered orally. |
Inclusion Criteria: * Body mass index (BMI) 19 - 40 kg/m\^2, inclusive * In good health based on medical history, physical examination, vital signs, and laboratory safety tests * No clinically significant abnormality on electrocardiogram (ECG) * For participants with hepatic insufficiency only, dia...
Elbasvir is a small molecule drug developed by Merck & Company, Inc. (ticker MRK) for hepatic insufficiency and human viral hepatitis. It is in Phase 1 clinical development and is also referred to as elbasvir (EBR).
Elbasvir is being studied for hepatic insufficiency and hepatitis, viral, human. Its clinical program includes a Phase 1 trial in hepatitis C infected males and a Phase 1 trial evaluating the influence of hepatic insufficiency on its pharmacokinetics.
Elbasvir is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the Phase 1 clinical trials evaluating elbasvir in hepatic insufficiency and human viral hepatitis.
Elbasvir is in Phase 1 clinical development. It is investigational and has not been approved. The program includes completed Phase 1 trials, with no active trials currently listed.
Elbasvir has been studied in two completed Phase 1 trials: NCT01797536, which evaluated the influence of hepatic insufficiency on elbasvir pharmacokinetics in 31 participants, and NCT01532973, which assessed safety, pharmacokinetics, and pharmacodynamics in hepatitis C infected males in 48 participants.
Yes, elbasvir is also known as elbasvir (EBR). EBR is an abbreviation for the same drug, a small molecule developed by Merck & Company, Inc. (ticker MRK) that is in Phase 1 development for hepatic insufficiency and human viral hepatitis.