Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01500616 | Telaprevir Open-Label Study in Co-Infected Patients | PHASE3 | COMPLETED | 122 | — | — | Jun 1, 2012 | Aug 1, 2014 | Aug 18, 2016 | 29 | Belgium, Germany +6 |
| NCT01054573 | VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo | PHASE3 | COMPLETED | 90 | — | — | Apr 1, 2010 | May 1, 2012 | May 8, 2013 | 48 | United States, Australia +13 |
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.
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.
| 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 + 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. |
| 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. |
| 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. |
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...