Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Emtricitabine/Tenofovir Disoproxil · 1 trial · 1 indication
Mean changes in alkaline phosphatase levels after 12 months treatment with combination antiretroviral therapy or placebo.
| Arm | Type | Description |
|---|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) & Raltegravir | EXPERIMENTAL | one Emtricitabine 200mg and Tenofovir Disoproxil 300mg tablet two Raltegravir 600mg tablets |
| Placebo | PLACEBO_COMPARATOR | Identical tablets resembling one Emtricitabine 200mg and Tenofovir Disoproxil 300mg tablet two Raltegravir 600mg tablets |
| Name | Type | Description |
|---|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) | DRUG | Emtricitabine (FTC) 200 mg/Tenofovir Disoproxil (TDF) 300 mg by mouth once per day |
| Raltegravir | DRUG | Raltegravir (RTF) 600 mg two tablets by mouth once per day |
| Placebo Oral Capsule [CEBOCAP] | DRUG | Two capsules identical to Raltegravir and one capsule identical to Truvada with no active ingredients by mouth once per day |
Inclusion Criteria: * over 18 years old of either sex, * Anti-mitochondrial antibody +ve or liver histology compatible with PBC, * stable UDCA dose of 13-15 mg/kg for \> 12 months or intolerant to UDCA, * ALP at least 1.67 x ULN or abnormal bilirubin less than 2x ULN * able to read and sign informe...
Emtricitabine/Tenofovir Disoproxil is an investigational small molecule being studied for the treatment of Primary Biliary Cholangitis (PBC), a chronic liver disease. It is currently in Phase 2 clinical development, with one completed trial evaluating its safety and efficacy in patients with this condition.
Emtricitabine/Tenofovir Disoproxil is a combination of two antiretroviral drugs, emtricitabine and tenofovir disoproxil, which are nucleoside/nucleotide reverse transcriptase inhibitors. In the context of Primary Biliary Cholangitis, the therapy is being investigated for its potential immunomodulatory effects, though the specific molecular target in this disease is not detailed.
Emtricitabine/Tenofovir Disoproxil is being developed by Merck & Company, Inc. (NYSE: MRK). The company is conducting clinical research to evaluate this combination therapy for Primary Biliary Cholangitis, a condition for which it is not yet approved.
Emtricitabine/Tenofovir Disoproxil is in Phase 2 clinical development for Primary Biliary Cholangitis. It is an investigational drug and has not been approved by regulatory authorities for this indication. One Phase 2 trial has been completed, with no active trials currently ongoing.
Emtricitabine/Tenofovir Disoproxil has been studied in one clinical trial, NCT03954327, titled 'Combination Antiretroviral Therapy (cART) for PBC'. This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 37 participants with Primary Biliary Cholangitis in Canada and has been completed.
Yes, Emtricitabine/Tenofovir Disoproxil is also known as FTC/TDF, a combination of emtricitabine and tenofovir disoproxil. This fixed-dose combination is being investigated for Primary Biliary Cholangitis under the development program by Merck & Company, Inc.