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This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV |
|
| Arm 2 | Placebo Comparator | RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5885 | Drug | tablet, 30 mg QD |
| |
| GS-9451 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the antiviral efficacy of response guided therapy. | 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. | Through 24 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of each regimen. | The primary safety endpoint is any AE leading to permanent discontinuation of study drugs. | Through 24 weeks post-treatment |
| To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bittoo Kanwar, MD | Gilead Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
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| Drug |
tablet, 200 mg QD |
|
| peginterferon alfa-2a | Biological | (solution for injection) 180 µg/week |
|
| ribavirin tablet | Drug | ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
|
| GS-9451 Placebo | Drug | Placebo to match GS-9451 QD |
|
HCV RNA levels, pharmacokinetics and viral sequencing |
| Through Day 10 on study |
| To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV. | Plasma samples will be collected and stored at each visit for possible resistance analysis. | 12 or 24 weeks |
| To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV. | Plasma concentrations of the study drug over time will be summarized using descriptive statistics. | Through 48 weeks of treatment |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Coronado | California | 92118 | United States |
| Costa Mesa | California | 92626 | United States |
| San Diego | California | 92123 | United States |
| Aurora | Colorado | 80045 | United States |
| Englewood | Colorado | 80110 | United States |
| Bradenton | Florida | 34209 | United States |
| Baltimore | Maryland | 21202 | United States |
| Baltimore | Maryland | 21229 | United States |
| Burlington | Massachusetts | 01805 | United States |
| Kansas City | Missouri | 64131 | United States |
| Forest Hills | New York | 11375 | United States |
| Manhasset | New York | 11030 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Nashville | Tennessee | 37211 | United States |
| Arlington | Texas | 76012 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78215 | United States |
| Fairfax | Virginia | 22031 | United States |
| Herston | Queensland | 4029 | Australia |
| San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586541 | ledipasvir |
| C573362 | GS-9451 |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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