Phase 2
Completed N=77
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
Source: ClinicalTrials.gov NCT02745535 ↗Enrolled (actual)
77
Serious AEs
15.6%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With Grade 3 and 4 Adverse Events — 12 Participants
Summary
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3 and 4 Adverse Events |
12 | — |
| PRIMARY Number of Participants Who Achieve Sustained Virologic Response (SVR) 12 Weeks After Completion of Therapy (SVR12) |
70 | — |
| SECONDARY Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy. |
71 | — |
| SECONDARY Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy. |
70 | — |
| SECONDARY Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy. |
70 | — |
Eligibility Criteria
Inclusion Criteria
- Available for clinical follow-up through Week 44 after enrollment.
- Recurrent HCV GT-1
- Exposure to combination DAA therapy
- Able and willing to complete the informed consent process.
- Use of protocol specified methods of contraception
- Hepatitis B coinfected participants must have evidence of chronic infection and controlled on treatment
- HIV coinfected participants must have HIV status of one of the following:
- HIV untreated for >8 weeks prior to screening, CD4 >500, no intention of initiating ARV therapy for the duration of the trial.
- HIV suppressed on a stable, protocol-approved ARV regimen for >4 weeks prior to screening.
Exclusion Criteria
- Combination DAA therapy was completed or discontinued less than 8 weeks prior to enrollment.
- Current or prior history of any clinically significant illness, organ transplantation, and/or concomitant medication that may interfere with the subject treatment, assessment of compliance with the protocol.
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- Laboratory results outside acceptable ranges at screening.
- Female who is pregnant, breast-feeding or planning to become pregnant during study.
Data sourced from ClinicalTrials.gov (NCT02745535). 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.