Phase 2
Completed N=64
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
Source: ClinicalTrials.gov NCT01054729 ↗Enrolled (actual)
64
Serious AEs
7.9%
Results posted
Feb 2014
Primary outcomePrimary: Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period — 87.5; 83.3; 86.7; 85.7 percentage of participants
Summary
Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period |
87.5; 83.3; 86.7; 85.7; 12.5; 27.8 | — |
| SECONDARY Change in Circulating HCV RNA at Week 4 |
-5.323; -5.081; -5.346; -2.8 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response at Week 4 |
87.5; 94.4; 93.3; 21.4 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment |
56.3; 72.2; 86.7; 50.0; 56.3; 83.3 | — |
| SECONDARY Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0 |
218.08; 332.26; 1257.50 | — |
| SECONDARY Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27 |
253.54; 475.14; 1355.65 | — |
| SECONDARY Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0 |
280.19; 585.56; 1867.24 | — |
| SECONDARY Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27 |
375.70; 732.27; 2011.23 | — |
| SECONDARY Plasma Pharmacokinetics of GS-331007: Cmax at Day 0 |
197.32; 357.33; 662.13 | — |
| SECONDARY Plasma Pharmacokinetics of GS-331007: Cmax at Day 27 |
233.79; 357.38; 717.23 | — |
| SECONDARY Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0 |
2173.18; 3984.88; 7559.91 | — |
| SECONDARY Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27 |
2256.81; 3389.23; 7398.99 | — |
| SECONDARY Plasma Pharmacokinetics of GS-566500: Cmax at Day 0 |
69.99; 145.51; 293.35 | — |
| SECONDARY Plasma Pharmacokinetics of GS-566500: Cmax at Day 27 |
64.75; 132.72; 237.46 | — |
| SECONDARY Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0 |
266.22; 645.95; 1315.94 | — |
| SECONDARY Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27 |
262.00; 571.95; 1072.91 | — |
| SECONDARY Percentage of Participants Who Developed Resistance to Sofosbuvir |
0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naive males and females, 18-65 years of age
- Genotype 1 HCV infection
- Negative pregnancy test for females of childbearing age
- Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin
Exclusion Criteria
- Hepatitis B or HIV infection
- Pregnant or breast feeding females or male partners of pregnant females
- Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
- History or evidence of medical condition associated with chronic liver disease other than HCV
Data sourced from ClinicalTrials.gov (NCT01054729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.