FDA Okays Another Once-Daily HIV Pill

By Joyce Frieden, News Editor, MedPage Today
Reviewed by

August 10, 2011
WASHINGTON -- The FDA has approved a second once-daily tablet for HIV -- this one combining three medications: emtricitabine, rilpivirine, and tenofovir.
The pill, manufactured by Gilead Sciences, combines that company's Truvada -- itself a combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir -- with rilpivirine (Edurant), a recently approved non-nucleoside reverse transcriptase inhibitor made by Tibotec Pharmaceuticals.
The new pill will be called Complera.
"In the 30 years since the first AIDS cases were reported, we've made incredible strides in the treatment of this disease," said Tony Mills, MD, a participating investigator in ongoing Complera studies.
"Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy," Mills said in a press release.
The first once-daily HIV pill, a combination of efavirenz, emtricitabine, and tenofovir (Atripla), was approved by the FDA in July 2006. Atripla is marketed by Gilead and Bristol-Myers Squibb.
Complera's approval is based on data from two phase III trials, ECHO and THRIVE, which compared the safety and efficacy of rilpivirine with efavirenz. The studies included a background drug regimen, and most patients in the rilpivirine arms were also taking Truvada.
A bioequivalence study conducted by Gilead demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir, the company said, noting that Complera does not cure HIV-1 infection or help prevent the transmission of HIV to others.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir, one of Complera's ingredients, in combination with other antiretrovirals, the company noted.
Complera is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of the drug has not been established in patients coinfected with HBV and HIV-1.
Complera should not be co-administered with certain anticonvulsants (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin), certain antimycobacterials (such as rifabutin, rifampin, and rifapentine), or proton pump inhibitors such as lansoprazole and omeprazole, because these could result in loss of virologic response and result in resistance to the drug, according to the company.
The most common side effects from rilpivirine included insomnia and headache; the most common adverse events with emtricitabine and tenofovir were diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
The information presented in this activity is that of the authors and does not
necessarily represent the views of the University of Pennsylvania School of Medicine,
MedPage Today, and the commercial supporter. Specific medicines discussed in this
activity may not yet be approved by the FDA for the use as indicated by the writer or
reviewer. Before prescribing any medication, we advise you to review the complete
prescribing information, including indications, contraindications, warnings,
precautions, and adverse effects. Specific patient care decisions are the responsibility
of the healthcare professional caring for the patient. Please review our Terms of Use.
2004-2011 MedPage Today, LLC. All Rights Reserved.


Anthropology 202

Culture and Biology CONCORDIA UNIVERSITY Anthropology 203/4 A Winter 2012 Monday/Wednesday 8:45-10:00 am - Rm: H-557 Professor: Salinda S. Hess, PhD Office hours: 11-noon Mon/Wed or by appt. This course is based on the framework of an introduction to physical anthropology, as indicated in the outline below; however, bicultural anthropology will provide the impetus

Robbert j. verkes cv

Robbert J. Verkes, MD, The Netherlands Cashier of the Board Biography Dr. Robbert J. Verkes is psychiatrist and clinical pharmacologist and holds a position as associate professor at the Department of Psychiatry at the Radboud University Medical Centre, Nijmegen, The Netherlands. He has been medical director of the Pompe Clinic for Forensic Psychiatry in Nijmegen. He currently is con

Copyright © 2018 Medical Abstracts