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A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection
Phase 2 trial testing ombitasvir/paritaprevir/ritonavir and dasabuvir in Chronic Hepatitis C Infection in 29 participants. Completed in 7 July 2017.
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 3 February 2015 |
| Primary completion | 28 October 2016 |
| Estimated completion | 7 July 2017 |
AbbVie — full company profile →
Adults 18 to 99, any sex, with Chronic Hepatitis C Infection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
| Group | Value | 95% CI |
|---|---|---|
| Part 1, 3-DAA With SOF With or Without RBV | 95.5 | 78.2 – 99.2 |
SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug
| Group | Value | 95% CI |
|---|---|---|
| Part 2, 3-DAA With RBV | 85.7 | 48.7 – 97.4 |
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after \< LLOQ during treatment, confirmed increase of \> 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Part 1, 3-DAA With SOF With or Without RBV | 0.0 | 0.0 – 14.9 |
| Part 2, 3-DAA With RBV | 14.3 | 2.6 – 51.3 |
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA \< LLOQ at the end of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Part 1, 3-DAA With SOF With or Without RBV | 4.8 | 0.8 – 22.7 |
| Part 2, 3-DAA With RBV | 0.0 | 0.0 – 39.0 |
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part 1, 3-DAA With SOF Wit… | Part 2, 3-DAA With RBV |
|---|---|---|---|
| CELLULITIS | Infections and infestations | — | — |
| PNEUMONIA | Infections and infestations | — | — |
| Reaction | System | Part 1, 3-DAA With SOF Wit… | Part 2, 3-DAA With RBV |
|---|---|---|---|
| HEADACHE | Nervous system disorders | — | — |
| FATIGUE | General disorders | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — |
| INSOMNIA | Psychiatric disorders | — | — |
| NAUSEA | Gastrointestinal disorders | — | — |
| DIZZINESS | Nervous system disorders | — | — |
| ASTHENIA | General disorders | — | — |
| PYREXIA | General disorders | — | — |
| GASTROENTERITIS | Infections and infestations | — | — |
| URINARY TRACT INFECTION | Infections and infestations | — | — |
| IRRITABILITY | Psychiatric disorders | — | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — | — |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | — | — |
| RASH | Skin and subcutaneous tissue disorders | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — |
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | — | — |
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | — | — |
| VERTIGO | Ear and labyrinth disorders | — | — |
| VERTIGO POSITIONAL | Ear and labyrinth disorders | — | — |
| CUSHING'S SYNDROME | Endocrine disorders | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — |
| DENTAL CARIES | Gastrointestinal disorders | — | — |
| DRY MOUTH | Gastrointestinal disorders | — | — |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | — | — |
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | — | — |
| MOUTH ULCERATION | Gastrointestinal disorders | — | — |
| ORAL PAIN | Gastrointestinal disorders | — | — |
| VOMITING | Gastrointestinal disorders | — | — |
| CYST | General disorders | — | — |
| ENERGY INCREASED | General disorders | — | — |
| FEELING COLD | General disorders | — | — |
| MALAISE | General disorders | — | — |
| OEDEMA PERIPHERAL | General disorders | — | — |
| CONJUNCTIVITIS BACTERIAL | Infections and infestations | — | — |
| EAR INFECTION | Infections and infestations | — | — |
| INFLUENZA | Infections and infestations | — | — |
| SINUSITIS | Infections and infestations | — | — |
| STAPHYLOCOCCAL SKIN INFECTION | Infections and infestations | — | — |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | — | — |
| MUSCLE STRAIN | Injury, poisoning and procedural complications | — | — |
Most-reported serious reactions: CELLULITIS, PNEUMONIA.
Data from ClinicalTrials.gov NCT02356562 adverse events section.
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts. Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure. Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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