FDA
Approves NNRTI Rilpivirine (Edurant, TMC278)
SUMMARY
New NNRTI rilpivirine (brand name Edurant, formerly TMC278)
received U.S. Food and Drug Administration (FDA) approval
Friday for HIV patients starting first-line therapy. |
Rilpivirine
is a next-generation non-nucleoside reverse transcriptase inhibitor
(NNRTI) developed by Tibotec. The Phase
3 ECHO and THRIVE trials of treatment-naive participants
showed that rilpivirine works as well as the popular NNRTI efavirenz
(Sustiva), but causes fewer side effects, especially neuropsychiatric
symptoms.
Studies
indicate that rilpivirine may not work as well for people
with high baseline viral load (> 100,000 copies/mL), and
individuals who experience treatment failure are prone to
develop resistance mutations. The FDA has not approved the
new drug for treatment-experienced patients.
Tibotec
and Gilead are also seeking approval of a fixed-dose
combination pill containing rilpivirine plus tenofovir/efavirenz,
a single-tablet regimen that could compete with Atripla.
Below
is an edited excerpt from an FDA press release announcing
the approval.
FDA
Approves New HIV Treatment
The
U.S. Food and Drug Administration today approved Edurant
(rilpivirine) in combination with other antiretroviral
drugs for the treatment of HIV-1 infection in adults
who have never taken HIV therapy (treatment-naive).
Edurant belongs to a class of HIV drugs called non-nucleoside
reverse transcriptase inhibitor (NNRTI). The drug works
by blocking HIV viral replication. Edurant is to be used
as part of a highly active antiretroviral therapy (HAART)
regimen that is designed to suppress the amount of HIV (viral
load) in the blood. Edurant is a pill taken once a day with
food.
"Patients may respond differently to various HIV drugs
or experience varied side effects. FDA's approval of Edurant
provides an additional treatment option for patients who
are starting HIV therapy," said Edward Cox, MD, MPH,
director, Office of Antimicrobial Products in the FDA's
Center for Drug Evaluation and Research.
The safety and effectiveness of Edurant is based on 48-week
data from two Phase 3 clinical trials with 1,368 adult subjects
with HIV infection, and from a 96-week (with extension to
192 weeks) trial. Patients had not received prior HIV therapy
and were selected to receive treatment with Edurant or efavirenz
(another FDA-approved NNRTI for the treatment of HIV infection).
Both drugs were given in combination with other antiretroviral
drugs.
Edurant was as effective as efavirenz in lowering viral
load. In the Edurant and efavirenz groups, 83 percent and
80 percent of subjects, respectively, had undetectable amounts
of HIV in their blood after 48 weeks of treatment. Patients
receiving Edurant who had a higher viral load at the start
of therapy were more likely not to respond to the drug than
were patients with a lower viral load at the start of therapy.
In addition, persons who failed therapy with Edurant developed
more drug resistance than patients who failed efavirenz.
The most commonly reported side effects in patients taking
Edurant included depression, difficulty sleeping (insomnia),
headache and rash. Fewer patients stopped taking the drug
due to side effects as compared to patients taking efavirenz.
Edurant does not cure HIV infection. Patients must stay
on continuous HIV therapy to control HIV infection and decrease
HIV-related illnesses.
5/20/11
Sources
Food and Drug Administration. FDA Approves New HIV Treatment.
Press release. May 20, 2011.
R Klein and K Struble, FDA. Approval of Edurant (rilpivirine)
a new NNRTI) for the treatment of HIV in treatment naive patients.
HIV/AIDS Update. May 20, 2011.
|
|
|
