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GS-5885 · 6 trials · 3 indications
To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA \< lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA \< Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
To evaluate antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA \< Lower Limit of Quantification (LLoQ) 24 weeks post-treatment) of response guided therapy (RGT) with GS-9451 + GS-5885, with peginterferon alfa-2a (PEG) and ribavirin (RBV) in treatment-experienced subjects.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks |
| Arm 2 | ACTIVE_COMPARATOR | GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks |
| Arm 3 | ACTIVE_COMPARATOR | GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks |
| Cohort 1 | ACTIVE_COMPARATOR | GS-5885 (3 mg), once daily or matching placebo, once daily |
| Cohort 2 | ACTIVE_COMPARATOR | GS-5885 (10 mg), once daily or matching placebo, once daily |
| Cohort 3 | ACTIVE_COMPARATOR | GS-5885 (30 mg), once daily or matching placebo, once daily |
| Cohort 4 | ACTIVE_COMPARATOR | GS-5885 ( up to 90 mg), once daily or matching placebo, once daily |
| Cohort 5 | ACTIVE_COMPARATOR | GS-5885 (up to 90 mg), once daily or matching placebo, once daily |
| Cohort 6 (optional) | ACTIVE_COMPARATOR | GS-5885 (up to 90 mg), once daily or matching placebo, once daily |
| Name | Type | Description |
|---|---|---|
| GS-5885 tablet | DRUG | GS-5885 tablet, 90 mg, QD |
| GS-9451 tablet | DRUG | GS-9451 tablet, 200 mg QD |
| tegobuvir capsule | DRUG | tegobuvir capsule, 30 mg BID |
| ribavirin tablet | DRUG | ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
| placebo matching ribavirin tablet | DRUG | placebo matching ribavirin tablet, BID |
| placebo matching tegobuvir capsule | DEVICE | placebo matching tegobuvir capsule, BID |
| GS-5885 | DRUG | Drug: GS-5885 tablet GS-5885 tablet, 90 mg, QD |
| GS-9451 | DRUG | Drug: GS-9451 tablet GS-9451 tablet, 200 mg QD |
| tegobuvir | DRUG | tegobuvir 30 mg BID |
| placebo to match tegobuvir | DRUG | tegobuvir placebo BID |
| placebo to match RBV | DRUG | Ribovirin placebo BID |
| Ribavirin | DRUG | Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID |
| peginterferon alfa-2a | BIOLOGICAL | (solution for injection) 180 µg/week |
| GS-9451 Placebo | DRUG | Placebo to match GS-9451 QD |
| Placebo | DRUG | tablet, oral, once daily for 3 days |
Inclusion Criteria: * Adult subjects 18 and older with chronic HCV infection * Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis * Monoinfection with HCV genotype 1a or 1b * Interferon ineligible or intolerant * Body mass index (BMI) betwee...
GS-5885 is an investigational small molecule being developed for the treatment of chronic hepatitis C virus (HCV) infection, specifically genotype 1a or 1b. It has been studied in patients with chronic genotype 1 HCV infection, including those who are treatment-naive, treatment-experienced, or interferon ineligible or intolerant.
GS-5885 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. The drug has completed Phase 2 clinical trials for chronic hepatitis C virus infection.
GS-5885 is in Phase 2 clinical development. It has completed four clinical trials, including one Phase 1 multiple ascending dose study and three Phase 2 studies. All trials are completed, and the drug remains investigational, not yet approved by regulatory authorities.
GS-5885 has been studied in four completed trials. NCT01193478 was a Phase 1 multiple ascending dose study in treatment-naive patients. NCT01353248, NCT01371578, and NCT01434498 were Phase 2 trials evaluating GS-5885 in combination with other antiviral agents in patients with chronic genotype 1 HCV infection.
GS-5885 is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available clinical trial information. The drug has been studied in combination with other direct-acting antivirals and ribavirin for the treatment of chronic hepatitis C virus infection.
GS-5885 is the developmental code name for the drug later known as ledipasvir. It was studied in clinical trials as GS-5885, and the compound is now recognized as ledipasvir, an HCV NS5A inhibitor used in combination therapies for chronic hepatitis C.