Phase 3
Completed N=318
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
Hepatitis C · Human Immunodeficiency Virus Infection · Chronic Hepatitis C · Compensated Cirrhosis and Non-cirrhotics
Source: ClinicalTrials.gov NCT01939197 ↗
Enrolled (actual)
318
Serious AEs
3.5%
Results posted
Nov 2017
Primary outcomePrimary: Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) — 97.0 percentage of participants
◆ Published Evidence
Highly cited
305citations · ~28 / year
Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial.
Summary
The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment.
Linked Publications (4)
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Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial.
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Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis.
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How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World?
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Pharmacokinetic Evaluation of Darunavir Administered Once or Twice Daily in Combination with Ritonavir or the Three-Direct-Acting Antiviral Regimen of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults Coinfected with Hepatitis C and Human Immunodeficiency Viruses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) |
97.0 | — |
| SECONDARY Percentage of Participants in Part 1a Achieving SVR12 |
93.5; 90.6 | 1.000 |
| SECONDARY Percentage of Participants in Part 1b Achieving SVR12 |
100; 100; 100 | — |
| SECONDARY Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12 |
75.0; 80.0 | — |
| SECONDARY Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall |
96.4; 96.4 | — |
| SECONDARY Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period |
0; 3.1 | — |
| SECONDARY Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period |
0; 0; 0 | — |
| SECONDARY Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period |
0.5; 0; 25.0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants in Part 1a With Relapse12 |
3.3; 0 | — |
| SECONDARY Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall |
0; 0; 0 | — |
| SECONDARY Percentage of Participants in Part 2 With Relapse12 |
0.5; 0; 0; 0.8; 0; 0 | — |
| SECONDARY Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment |
93.5; 90.6; 96.8; 93.8 | — |
| SECONDARY Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment |
100; 83.3; 90.9; 100; 75.0; 86.4 | — |
| SECONDARY Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment |
89; 90.5; 100; 89.6; 78.9; 85.7 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic HCV infection at screening defined as: positive anti-HCV antibodies (Ab) at screening and HCV RNA > 1,000 IU/mL at screening.
- Plasma HIV-1 RNA < 40 copies/mL during screening using Abbott RealTime HIV-1 assay.
- On a stable qualifying HIV-1 antiretroviral therapy regimen.
Exclusion Criteria
- Positive test result at screening for hepatitis B surface antigen.
- Evidence of HCV genotype other than genotype 1 or genotype 4 during screening.
- Receipt of any other investigational or commercially available anti-HCV agents (for example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon (including pegylated-interferon alfa-2a or alfa-2b), sofosbuvir and ribavirin.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or ribavirin.
- Chronic human immunodeficiency virus, type 2 (HIV-2) infection.
Data sourced from ClinicalTrials.gov (NCT01939197) and the linked publication. 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.