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A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil
Phase 3 trial testing ombitasvir/paritaprevir/ritonavir and dasabuvir in Chronic Hepatitis C Infection in 222 participants. Completed in 26 September 2016.
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 222 |
| Start date | 27 April 2015 |
| Primary completion | 4 July 2016 |
| Estimated completion | 26 September 2016 |
AbbVie — full company profile →
18 and older, 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. Participants with missing data were counted as failures.
| Group | Value | 95% CI |
|---|---|---|
| 3-DAA ± RBV | 96.4 | 93.1 – 98.2 |
SVR12 was defined as plasma HCV RNA level \<LLOQ\]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.
| Group | Value | 95% CI |
|---|---|---|
| Fibrosis Stage F3 | 96.6 | 90.6 – 98.8 |
| Fibrosis Stage F4 | 96.2 | 91.5 – 98.4 |
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.
| Group | Value | 95% CI |
|---|---|---|
| Treatment-Naive | 96.1 | 90.3 – 98.5 |
| Pegylated Interferon (PegIFN)/RBV Null Responders | 95.5 | 78.2 – 99.2 |
| Pegylated Interferon (PegIFN)//RBV Partial Responders | 100 | NA – NA |
| Pegylated Interferon (PegIFN)/RBV Non-Responders | 100 | 87.1 – 100.0 |
| Pegylated Interferon (PegIFN)/RBV Relapser | 97.1 | 85.1 – 99.5 |
| Pegylated Interferon (PegIFN)/RBV Breakthrough | 100 | 78.5 – 100.00 |
| IFN Interolerant | 85.7 | NA – NA |
| Other | 91.7 | 64.6 – 98.5 |
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.
| Group | Value | 95% CI |
|---|---|---|
| Interferon (IFN)-Ineligible, Treatment-Naive | 90.0 | 59.6 – 98.2 |
| Interferon (IFN)-Eligible, Treatment-Naive | 96.7 | 90.8 – 98.9 |
| Interferon (IFN)-Ineligible, Treatment-Experienced | 85.7 | NA – NA |
| Interferon (IFN)-Eligible, Treatment-Experienced | 97.3 | 92.5 – 99.1 |
The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.
| Group | Value | 95% CI |
|---|---|---|
| Fibrosis Stage F3 | 0.5 | ± 10.97 |
| Fibrosis Stage F4 | 0.8 | ± 10.64 |
| Group | Value | 95% CI |
|---|---|---|
| Fibrosis Stage F3 | 3.8 | ± 13.25 |
| Fibrosis Stage F4 | 4.2 | ± 15.72 |
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baselin
| Group | Value | 95% CI |
|---|---|---|
| Fibrosis Stage F3 | -0.5 | ± 9.22 |
| Fibrosis Stage F4 | 1.3 | ± 8.59 |
| Group | Value | 95% CI |
|---|---|---|
| Fibrosis Stage F3 | 0.1 | ± 6.42 |
| Fibrosis Stage F4 | 2.1 | ± 7.60 |
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered
| Group | Value | 95% CI |
|---|---|---|
| Fibrosis Stage F3 | 2.4 | ± 3.72 |
| Fibrosis Stage F4 | -0.6 | ± 8.47 |
| Group | Value | 95% CI |
|---|---|---|
| Fibrosis Stage F3 | 2.4 | ± 11.39 |
| Fibrosis Stage F4 | 2.5 | ± 9.15 |
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 3-DAA ± RBV |
|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | — |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | — |
| HEPATIC FAILURE | Hepatobiliary disorders | — |
| GASTROENTERITIS | Infections and infestations | — |
| LUNG ADENOCARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | — |
| RENAL FAILURE | Renal and urinary disorders | — |
| Reaction | System | 3-DAA ± RBV |
|---|---|---|
| HEADACHE | Nervous system disorders | — |
| FATIGUE | General disorders | — |
| NAUSEA | Gastrointestinal disorders | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — |
| ASTHENIA | General disorders | — |
| DIARRHOEA | Gastrointestinal disorders | — |
| ANAEMIA | Blood and lymphatic system disorders | — |
| DYSPEPSIA | Gastrointestinal disorders | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — |
| INSOMNIA | Psychiatric disorders | — |
Most-reported serious reactions: DIARRHOEA, OESOPHAGEAL VARICES HAEMORRHAGE, HEPATIC FAILURE, GASTROENTERITIS, LUNG ADENOCARCINOMA METASTATIC, TRANSIENT ISCHAEMIC ATTACK, RENAL FAILURE.
Data from ClinicalTrials.gov NCT02442271 adverse events section.
The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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