Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glecaprevir/Pibrentasvir · 3 trials · 6 indications
Number of non-cirrhotic treatment-experienced HCV genotype 1 with a NS5Ai inhibitor + SOF +/-RBV participants with undetectable HCV RNA (HCV RNA \<Lower Limit of Quantification -LLOQ) 12 weeks after completing G/P 300 mg/100 mg daily for 12 weeks (Arm A) vs. 16 weeks of G/P 300 mg/100 mg daily (Arm B)
Number of cirrhotic participants who are treatment experienced with a NS5A inhibitor + SOF +/RBV with undetectable HCV RNA 12 weeks after completing G/P plus RBV for 12 wks vs. G/P for 16 Wks
Number of subjects who discontinued G/P due to adverse events
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 compared with the historical SVR12 rate for the current standard of care regimens (sofosbuvir \[SOF\]/ledipasvir \[LDV\] + ribavirin \[RBV\] OR SOF + daclatasvir \[DCV\] + RBV). Participants with missing data after backward imputation were counted as non-responders.
SVR12 defined as unquantifiable HCV RNA (less than the lower limit of quantification \[LLOQ\], target detected \[TD\] or target not detected \[TND\]) at study visit 12 weeks post treatment (Week 16). If a participant did not have HCV RNA measurement at Week 16, the participant was considered as SVR12 failure, unless there were preceding and subsequent HCV RNA measurements that were both LLOQ (either TD or TND).
Study protocol required reporting of (1) AEs Grade greater than or equal to 2, (2) AEs that led to a change in study treatment regardless of grade and (3) AEs meeting ICH definition of serious AE (SAE) or Expedited AE (EAE) reporting requirement. DAIDS AE Grading Table (V2.1) and DAIDS EAE Manual (V2.0) were used.
Number of participants who completed 4 weeks of treatment without discontinuation due to AEs
| Arm | Type | Description |
|---|---|---|
| Arm A: G/P 300 mg/120 mg QD for 12 Wks | EXPERIMENTAL | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks. |
| Arm B: G/P 300 mg/120 mg QD for 16 Wks | EXPERIMENTAL | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks) |
| Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | EXPERIMENTAL | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks) |
| Arm D: G/P 300 mg/120 mg QD for 16 Wks | EXPERIMENTAL | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks) |
| Glecaprevir/Pibrentasvir | EXPERIMENTAL | Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| Glecaprevir/Pibrentasvir (G/P) | EXPERIMENTAL | Participants were assigned to receive G/P FDC tablets to be taken orally once daily for 4 weeks (Step 1). Participants who experienced HCV re-infection, suspected relapse, virologic failure, or undefined post-treatment viremia in Step 1 were offered to enter Step 2 for re-treatment. HCV re-treatment regimens may have included G/P FDC tablets orally once daily for 8-16 weeks, or alternate regimens through clinical care. |
| Name | Type | Description |
|---|---|---|
| Glecaprevir/Pibrentasvir (G/P) 300mg/120mg | DRUG | daily |
| Ribavirin 200Mg Tablet | DRUG | Weight-based 1000-1200 mg |
| glecaprevir/pibrentasvir | DRUG | Tablet; glecaprevir coformulated with pibrentasvir |
| Glecaprevir/Pibrentasvir (G/P) | DRUG | Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally. |
Inclusion Criteria: 1. Male or female at least 18 years of age at time of screening. 2. A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV for chronic HCV genotype 1 infection. 3. Treatment must have been completed at least 1 month prior to Screening Visit. 4. Scre...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
Glecaprevir/Pibrentasvir is used for the treatment of chronic Hepatitis C virus (HCV) infection, including genotypes 1 through 6. It is being studied in adults and pediatric patients, and in some trials includes those with HIV co-infection or acute HCV infection.
Glecaprevir/Pibrentasvir is a combination of two direct-acting antiviral agents that target different steps in the HCV replication cycle. Glecaprevir inhibits the NS3/4A protease, while pibrentasvir inhibits the NS5A protein, together blocking viral replication.
Glecaprevir/Pibrentasvir is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.
Glecaprevir/Pibrentasvir is in Phase 3 clinical development for chronic Hepatitis C virus infection. It is an investigational drug and has not been approved by the FDA based on the information provided.
Glecaprevir/Pibrentasvir has completed nine clinical trials, including NCT03067129 in pediatric subjects, NCT03212521 in treatment-naive adults, NCT03222583 in Asian adults, and NCT04903626 in acute HCV infection. All trials are completed, with no active trials ongoing.
Yes, Glecaprevir/Pibrentasvir is also known as ABT-493/ABT-530, as referenced in clinical trial NCT03222583. The combination is being studied under both names in clinical research.