EDURANT (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). EDURANT is available as a white to off-white, film-coated, round, biconvex, 6.4 mm tablet for oral administration. Each tablet contains 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of rilpivirine.
EDURANT™, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients.
This indication is based on Week 48 safety and efficacy analyses from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naive subjects and Week 96 safety and efficacy analyses from a Phase 2b trial in treatment-naive subjects [see Clinical Studies].
The following points should be considered when initiating therapy with EDURANT:
- More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy [ see Clinical Studies
- The observed virologic failure rate in EDURANT treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [ see Clinical Pharmacology
- More subjects treated with EDURANT developed lamivudine/emtricitabine associated resistance compared to efavirenz [ see Clinical Pharmacology
Media Articles Related to Edurant (Rilpivirine)
Added benefit not proven rilpivirine combination product in hiv-1 patients with previous antiretroviral treatment:
Source: HIV / AIDS News From Medical News Today [2014.04.09]
Only study cited in the dossier was too short / appropriate comparator therapy not implementedThe German Institute for Quality and Efficiency in Health Care (IQWiG) reassessed the antiviral...
Published Studies Related to Edurant (Rilpivirine)
Rilpivirine: a second-generation nonnucleoside reverse transcriptase inhibitor. 
CONCLUSION: Rilpivirine is a viable NNRTI for HIV-infected patients who have not
Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in
treatment-naive HIV-1-infected patients: pooled results from the phase 3
double-blind randomized ECHO and THRIVE Trials. 
THRIVE trials comparing rilpivirine (TMC278) and efavirenz... CONCLUSIONS: At week 48, rilpivirine 25 mg once daily and efavirenz 600 mg once
Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive
adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind
active-controlled trial. 
with tenofovir-disoproxil-fumarate and emtricitabine... INTERPRETATION: Rilpivirine showed non-inferior efficacy compared with efavirenz,
Clinical Trials Related to Edurant (Rilpivirine)
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants [Recruiting]
The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what
the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics
(what the medication does to the body) of TMC278 long acting (slowly effective after initial
dosage and maintaining its effects over a long period of time) when administered as an
intramuscular (ie, in to the muscle) injection in adult participants who are seronegative
for human immunodeficiency virus type 1 (HIV-1).
The Rilpivirine Cerebrospinal-fluid (CSF) Study [Recruiting]
This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral
therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of
the study the participants will attend clinic where they will have blood collected followed
by a lumbar puncture where cerebrospinal fluid will be collected to measure drug
concentration. The participants will then restart their original regime with nevirapine.
A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection [Not yet recruiting]
The purpose of this study is to assess the safety and effectiveness of rilpivirine
hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment
of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human
immunodeficiency virus type 1 (HIV-1) infection.
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Efficacy of TMC278 in Human Immunodeficiency Virus Infected Adolescents [Recruiting]
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the
drug), safety and effectiveness of TMC278 25 mg once daily in combination with an
investigator-selected background regimen containing 2 nucleoside reverse transcriptase
inhibitors (NRTIs) (zidovudine [AZT]/lamivudine [3TC] or abacavir [ABC]/3TC) in
antiretroviral (ARV) treatment.
A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants [Recruiting]
The purpose of the study is to evaluate the effect of steady-state (constant concentration
of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin
is absorbed in the body, distributed within the body, and removed from the body) of a single
dose of metformin, over time, in healthy adult participants.
Reports of Suspected Edurant (Rilpivirine) Side Effects
Rash Generalised (6),
Abortion Spontaneous (4),
Cystic Lymphangioma (4),
Renal Failure Acute (4),
Loss of Consciousness (3),
Blood Creatinine Increased (3),
Blood Triglycerides Increased (1),
CD4 Lymphocytes Decreased (1), more >>
Page last updated: 2014-04-09