Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-42039556-AMR-G-001
TMC647055 · 2 trials · 2 indications
SVR12 is defined as undetectable HCV RNA at the actual end of treatment and HCV RNA less than 25 IU/mL at 12 Weeks after the actual end of treatment.
Number of patients with adverse events, serious adverse events, abnormal changes in safety related laboratory values, abnormal changes in vital signs and physical examination, and abnormal echocardiogram.
| Arm | Type | Description |
|---|---|---|
| Panel 1 | EXPERIMENTAL | 10 chronic HCV genotype 1a (GT1a) infected treatment-naive patients/prior relapsers who will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose ritonavir and ribavirin. |
| Panel 2 Arm 1 | EXPERIMENTAL | 10 chronic HCV GT1b infected treatment-naive patients/ prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir and ribavirin. |
| Panel 2 Arm 2 | EXPERIMENTAL | 10 chronic HCV GT1b infected treatment-naive patients/ prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir. |
| Panel 3 - Arm 1 | EXPERIMENTAL | 8 chronic HCV GT1a infected treatment naïve patients/prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir + ribavirin. |
| Panel 3 - Arm 2 | EXPERIMENTAL | 8 chronically HCV GT1b infected treatment naïve patients/prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir. |
| Panel 4 - Arm 1 | EXPERIMENTAL | 20 chronic HCV GT1a or GT1b infected treatment-naive patients/ prior relapsers will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805 (30 mg once daily) |
| Panel 4 - Arm 2 | EXPERIMENTAL | 20 chronic HCV GT1a or GT1b infected treatment-naive patients/ prior relapsers will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805 (60 mg once daily) |
| Panel 2 | EXPERIMENTAL | TMC647055 in combination with TVR for 10 or 14 days. Immediately followed by the extension phase: TVR at a dose of 750 mg every 8 hours for 12 weeks in combination with Peg IFN and RBV followed by either 12 or 36 weeks of PegIFN -RBV treatment alone. |
| Name | Type | Description |
|---|---|---|
| TMC647055 | DRUG | Type=exact number, unit=mg, number=150, form=capsule, route=oral. 3 or 4 capsules of 150 mg will be administered once daily. |
| TMC435 | DRUG | Type=exact number, unit=mg, number=75, form=capsule, route=oral. 1 capsule of 75 mg will be administered once daily. |
| Ritonavir | DRUG | Type=exact number, unit=mg, number=30 or 50, form=tablet or solution, route=oral. 0.375 mL or 0.625 ml (80 mg/mL) solution will be administered once daily. |
| Ribavirin | DRUG | Type=exact number, unit=mg, number=200, form=tablet, route=oral. 5 to 6 (1000 or 1200 mg) tablets will be administered once daily, divided in 2 daily doses. Patients meeting the Follow-UP (FU) treatment criteria specified in the protocol will receive treatment 5 or 6 (depending on bodyweight) tablets of ribavirin (equivalent to 200 mg/tablet) per day, divided in 2 daily doses for an additional 12 or 36 weeks. |
| Pegylated interferon alpha-2a (PegIFN) | DRUG | Type=exact number, unit=mcg, number=180, form=solution, route=subcutaneous injection. PegIFN 0.5 mL prefilled syringe equivalent to 180 mcg will be administered as a subcutaneous (under the skin) injection as follow-up (FU) treatment for 12 or 36 weeks based on follow-up treatment principles as described in the protocol. Patients meeting the Follow-UP (FU) treatment criteria specified in the protocol will receive treatment with Pegylated interferon alpha-2a (PegIFN) 0.5 mL prefilled syringe equivalent to 180 mcg administered as a subcutaneous (under the skin) injection for an additional 12 or 36 weeks. |
| GSK2336805 | DRUG | Type=exact number, unit=mg, number=30 or 60, form=tablet, route=subcutaneous injection. GSK2336805 one or two 30 mg tablet(s) taken orally (by mouth) once daily for 12 weeks. |
| TVR | DRUG | type=exact number, unit= mg, number=1125, form=tablet, route=oral use. TVR is to be taken twice daily at a dose of 1125 mg for 10 days. |
| PegFN | DRUG | type= exact number, unit= mcg, number=180, form=solution, route=subcutaneous. PegIFN is to be injected once per week for 24 or 48 weeks. |
| RBV | DRUG | type=exact number, unit=mg, number=1000 or 1200, form=tablet, route=oral use. RBV is to be taken at 1000 or 1200 mg per day in 2 divided doses, depending on the weight for 24 or 48 weeks. |
Inclusion Criteria: * Documented chronic genotype 1a or genotype 1b hepatitis C virus (HCV) infection with HCV ribonucleic acid (RNA) level \>100,000 IU/mL at screening * Treatment-naive or documented prior relapser to previous treatment regimens and has stopped treatment at least 3 months before s...
TMC647055 is an investigational small molecule being studied for the treatment of chronic hepatitis C virus infection, specifically genotype 1. It has been evaluated in combination with other antiviral agents, including TMC435 and ribavirin, in a Phase 2 clinical trial. It is not approved for any indication.
TMC647055 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company sponsored the clinical trials evaluating the drug in patients with chronic hepatitis C.
TMC647055 has completed a Phase 2 clinical trial and is not currently in active development. The Phase 2 study, NCT01724086, evaluated a 12-week combination therapy in patients with chronic genotype 1 hepatitis C. A Phase 1 trial, NCT01582035, was also completed.
TMC647055 has been studied in two completed clinical trials. The Phase 2 trial NCT01724086 enrolled 90 patients with chronic genotype 1 hepatitis C in Belgium and Germany. The Phase 1 trial NCT01582035 enrolled 7 patients with hepatitis C in Germany.
No, TMC647055 is not FDA approved. It is an investigational drug that has completed Phase 2 clinical development for chronic hepatitis C. It has not received marketing authorization for any indication.