Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Telaprevir · 8 trials · 6 indications
Protocol-defined adverse events whether serious or non-serious, that occur from the first use of investigational product (telaprevir) to 30 days after administration of the last dose of investigational product (telaprevir) will be part of the analysis.
Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.
SVR12 planned is defined as having plasma hepatitis C virus (HCV ) ribonucleic acid (RNA) level less than 25 IU/mL 12 weeks after the last planned dose of study medication.
A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.
The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \< 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of \< 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
Pharmacokinetic parameter Cmax of telaprevir is measured when telaprevir will be administered at 750 mg every 8 hours for 7 days added to stable methadone maintenance therapy.
Pharmacokinetic parameter Cmin of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy.
Pharmacokinetic parameter AUC of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy.
Pharmacokinetic parameter Cmax of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours.
Pharmacokinetic parameter Cmin of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
Pharmacokinetic parameter AUC of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
Pharmacokinetic parameter Cmax of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours.
Pharmacokinetic parameter Cmin of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
Pharmacokinetic parameter AUC of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
The pharmacokinetic parameter Cmax of telaprevir following administration of single and multiple oral doses of telaprevir in patients with moderate hepatic impairment (CPB \[Child-Pugh score 7 to 9\]) ie, Group 1, as compared to matched healthy patients ie, Group 2
The pharmacokinetic parameter AUC8h will be measured from time of administration up to 8 hours post dose of telaprevir following administration of single and multiple oral doses of telaprevir in patients with moderate hepatic impairment (CPB) ie, Group 1, as compared to matched healthy patients ie, Group 2
The pharmacokinetic parameter tmax will be measured following administration of single and multiple oral doses of telaprevir in patients with moderate hepatic impairment (CPB) ie, Group 1, as compared to matched healthy patients ie, Group 2
| Arm | Type | Description |
|---|---|---|
| open label telaprevir | EXPERIMENTAL | Depending on the patient's HAART regimen, 750 or 1125 mg telaprevir every 8 hours for 12 weeks in combination with pegylated interferon alfa and ribavirin for 48 weeks. |
| Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV) | EXPERIMENTAL | All patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 μg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV. |
| Telaprevir+Peg-IFN-alfa-2a+Ribavirin | EXPERIMENTAL | Patients will be treated for 12 weeks with telaprevir in combination with Pegylated interferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. |
| Treatment-naïve | EXPERIMENTAL | Treatment naïve participants will receive telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual ontreatment virologic response in this study. |
| Treatment-experienced | EXPERIMENTAL | Treatment-experienced participants received telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study. |
| Telaprevir + Standard Treatment | EXPERIMENTAL | Telaprevir 750 mg orally (by mouth) every 8h for 12 weeks plus standard treatment. Standard treatment is 180 mcg subcutaneous (under the skin) injection pegylated interferon (Peg-IFN) alfa-2a and 1000-1200 mg twice daily ribavirin (RBV) for 48 weeks. |
| Telaprevir + Methadone | EXPERIMENTAL | Patients will receive telaprevir 750 mg orally, every 8 hours from Day 1 to Day 7, along with methadone 30 to 130 mg, once daily. |
| Group 1 | EXPERIMENTAL | 10 patients with moderate hepatic impairment (CPB \[Child-Pugh score 7 to 9\]) |
| Group 2 | EXPERIMENTAL | 10 healthy control patients with normal hepatic function. Each healthy control patient is matched to a patient in Group 1 with respect to sex, age (± 5 years) and body mass index (BMI) (± 15%) |
| Group 3 | EXPERIMENTAL | up to 4 patients with severe hepatic impairment (CPC \[limited to Child Pugh score 10 to 12\]) |
| Panel 1 | EXPERIMENTAL | Part 1 of Panel 1: Participants will receive telaprevir 750 mg every 8 hours from Day 1 to Day 9 followed by a single 750-mg dose in the morning on Day 10. Part 2 of Panel 1: Participants will receive phenytoin 200 mg every 12 hours from Day 1 to Day 16 followed by a single 200-mg dose in the morning on Day 17; and telaprevir 750 mg every 8 hours from Day 8 to Day 16 followed by a single 750-mg dose in the morning on Day 17. |
| Panel 2 | EXPERIMENTAL | Part 1 of Panel 2: Participants will receive telaprevir 750 mg every 8 hours from Day 1 to Day 9 followed by a single 750-mg dose in the morning on Day 10. Part 2 of Panel 2: Participants will receive carbamazepine 200 mg every 12 hours from Day 1 to Day 16 followed by a single 200-mg dose in the morning on Day 17; and telaprevir 750 mg every 8 hours from Day 8 to Day 16 followed by a single 750-mg dose in the morning on Day 17. brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm. |
| Name | Type | Description |
|---|---|---|
| Telaprevir | DRUG | type = exact number, unit = mg, number = 750, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with pegylated interferon alfa (Peg-IFN alfa) and ribavirin (RBV) during 48 weeks for eligible non treated HIV patients and for patients whose highly active antiretroviral therapy (HAART) regimen is the combination of ritonavir-boosted atazanavir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or the combination of raltegravir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine. |
| Ribavirin | DRUG | Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy. |
| Pegylated-Interferon-alfa-2a | DRUG | Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy. |
| Pegylated interferon alfa-2a | DRUG | Type=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks. |
| pegylated interferon (Peg-IFN) alfa-2a | DRUG | 180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks. |
| ribavirin (RBV) | DRUG | 1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks. |
| Methadone | DRUG | Methadone 30 to 130 mg will be administered as a stable oral therapy from Day -14 to Day -1, in combination with telaprevir from Day 1 to Day 7, and then alone as a continued intake dose for an additional 30 to 32 days. |
| Phenytoin | DRUG | Type=exact number, unit=mg, number=100, form=capsule, route=oral. Two capsules of phenytoin will be administered as per the dosing regimen in Part 2 of Panel 1. |
| Carbamazepine | DRUG | Type=exact number, unit=mg, number=200, form=tablet, route=oral. One tablet of carbamazepine will be administered as per dosing regimen in Part 2 of Panel 2. |
Inclusion Criteria: - Have diagnosis of HIV-1 or HIV-2 infection, or HIV-1 and HIV-2 coinfection for more than 6 months before the screening visit. - Should have been on a stable permissible HAART regimen for more than 8 weeks before Day 1 without switches. OR Not on a HAART regimen and not expected...
Telaprevir is an investigational small molecule being studied for the treatment of chronic Hepatitis C virus (HCV) infection, including genotype 1 chronic Hepatitis C. It is also being evaluated in patients with hepatic impairment and in those co-infected with HIV-1. Telaprevir is in Phase 3 clinical development.
Telaprevir is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic Hepatitis C and related conditions.
Telaprevir is in Phase 3 clinical development for chronic Hepatitis C. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and effectiveness in treating HCV infection.
Telaprevir has been studied in several clinical trials, including NCT01498068 in Russian patients with genotype 1 chronic Hepatitis C, NCT01500616 in co-infected patients, NCT01513941 in patients with both HCV-1 and HIV-1, and NCT01600976 in patients with hepatic impairment. All trials are completed.
Telaprevir is also known by the brand name Incivo. It is a direct-acting antiviral agent being studied for the treatment of chronic Hepatitis C virus infection. The drug is being developed by Johnson & Johnson.