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A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
Phase 2 trial testing Simeprevir (SMV) in Hepatitis C, Chronic in 41 participants. Completed in 27 January 2016.
| Lead sponsor | Janssen Sciences Ireland UC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 41 |
| Start date | 19 May 2015 |
| Primary completion | 10 November 2015 |
| Estimated completion | 27 January 2016 |
| Sites | 4 locations across Belgium |
Janssen Sciences Ireland UC — full company profile →
Adults 18 to 70, any sex, with Hepatitis C, Chronic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Cmin is the minimum observed plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 2411 | ± 3778 |
| Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 6701 | ± 4179 |
The Cmax is the maximum observed plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 6767 | ± 6362 |
| Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 13691 | ± 7775 |
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
| Group | Value | 95% CI |
|---|---|---|
| Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 100492 | ± 115868 |
| Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 243564 | ± 159124 |
The Cmin is the minimum observed plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| Panel 2: LDV 90mg/SOF 400mg (Day 14) | 319 | ± 178 |
| Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 557 | ± 307 |
The Cmax is the maximum observed plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| Panel 2: LDV 90mg/SOF 400mg (Day 14) | 556 | ± 270 |
| Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 930 | ± 466 |
AUCtau is defined as area under the analyte concentration versus time curve during dosing interval tau, calculated by linear-linear trapezoidal summation.
| Group | Value | 95% CI |
|---|---|---|
| Panel 2: LDV 90mg/SOF 400mg (Day 14) | 9868 | ± 4930 |
| Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 17435 | ± 8772 |
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
| Group | Value | 95% CI |
|---|---|---|
| Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 3059 | ± 4236 |
| Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 8453 | ± 6455 |
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
| Group | Value | 95% CI |
|---|---|---|
| Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 6.00 | 4.00 – 12.00 |
| Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 6.00 | 0.47 – 10.00 |
The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC\[tau\]) divided by the dosing interval (tau).
| Group | Value | 95% CI |
|---|---|---|
| Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 4196 | ± 4833 |
| Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 10139 | ± 6628 |
Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100\*(\[Cmax Cmin\]/Cavg).
| Group | Value | 95% CI |
|---|---|---|
| Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 144 | ± 55.5 |
| Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 84.4 | ± 36.5 |
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
| Group | Value | 95% CI |
|---|---|---|
| Panel 2: LDV 90mg/SOF 400mg (Day 14) | 376 | ± 211 |
| Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 659 | ± 406 |
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
| Group | Value | 95% CI |
|---|---|---|
| Panel 2: LDV 90mg/SOF 400mg (Day 14) | 4.07 | 1.00 – 8.00 |
| Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 6.00 | 3.93 – 10.00 |
Time frame: Up to 10 Weeks for Panel 1 and 8 Weeks for Panel 2. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Panel 1:SMV 150mg(SOF 400m… | Panel 2: SMV 150mg+LDV 90m… |
|---|---|---|---|
| Fibula fracture | Injury, poisoning and procedural complications | — | — |
| Tibia fracture | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Panel 1:SMV 150mg(SOF 400m… | Panel 2: SMV 150mg+LDV 90m… |
|---|---|---|---|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — |
| Hot flush | Vascular disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Eye irritation | Eye disorders | — | — |
| Eyelid oedema | Eye disorders | — | — |
| Photophobia | Eye disorders | — | — |
| Vision blurred | Eye disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Catheter site paraesthesia | General disorders | — | — |
| Peripheral swelling | General disorders | — | — |
| Jaundice | Hepatobiliary disorders | — | — |
| Angular cheilitis | Infections and infestations | — | — |
| Ear infection | Infections and infestations | — | — |
| Genital abscess | Infections and infestations | — | — |
| Laryngitis | Infections and infestations | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Oral herpes | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Tooth infection | Infections and infestations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Disturbance in attention | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
Most-reported serious reactions: Fibula fracture, Tibia fracture.
Data from ClinicalTrials.gov NCT02421211 adverse events section.
The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype 1 infection.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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