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Also known as GS-5885 tablet, GS-7977, PSI-7977, LDV
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 antiviral being studied for the treatment of chronic hepatitis C virus infection, specifically chronic genotype 1a or 1b HCV. It has been evaluated in Phase 2 clinical trials, both alone and in combination with other direct-acting antivirals such as GS-9451 and tegobuvir, plus peginterferon alfa 2a and ribavirin.
GS-5885 is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead sponsored all four of the Phase 2 trials of GS-5885 listed in clinical registries, which together enrolled 825 participants across the United States, Canada, Puerto Rico, Germany, and Australia.
GS-5885 is in Phase 2 clinical development. All four registered trials of GS-5885 were Phase 2 studies, and all four are now completed, with no active trials currently listed. The studies were randomized, double-blind, and active-controlled, and enrolled a total of 825 participants with chronic genotype 1a or 1b hepatitis C.
GS-5885 has been studied in four completed Phase 2 trials: NCT01435226, NCT01434498, NCT01371578, and NCT01356160. These trials evaluated GS-5885 with GS-9451, tegobuvir, ribavirin, and peginterferon alfa 2a in treatment-experienced, interferon-ineligible or intolerant, and treatment-naive adults with chronic genotype 1 HCV infection.
Yes, GS-5885 tablet is another name used for GS-5885. Both names refer to the same investigational small molecule antiviral developed by Gilead Sciences for chronic hepatitis C virus infection, so searches using either name point to the same drug candidate and the same set of Phase 2 clinical trials.
The four completed Phase 2 trials of GS-5885 enrolled a combined total of 825 participants. Enrollment ranged from 163 participants in NCT01434498 and NCT01371578 to 170 in NCT01435226 and 351 in NCT01356160. All trials enrolled adults aged 18 years and older with chronic genotype 1 hepatitis C virus infection.