FDA Approves Emtricitabine/Rilpivirine/Tenofovir DF (Complera) for the Treatment of HIV in Treatment-Naive Adults
“On August 10, 2011, FDA approved Complera™, a fixed dose combination (FDC) drug product containing emtricitabine/rilpivirine/tenofovir DF (FTC/RPV/TDF) for the treatment of HIV. The recommended dose of Complera™ is one tablet, containing 200mg/25mg/300mg of FTC/RPV/TDF, once daily, taken orally with a meal. …
“Emtricitabine/rilpivirine/tenofovir DF FDC is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in antiretroviral treatment naïve adult patients … .
“Emtricitabine/rilpivirine/tenofovir DF FDC is a complete regimen for treatment of HIV infection in treatment naïve patients because it contains a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) (rilpivirine) and 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (emtricitabine and tenofovir DF).
“The following points should be considered when initiating therapy with emtricitabine/rilpivirine/tenofovir DF FDC:
- “More rilpivirine 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
- “The observed virologic failure rate in rilpivirine treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz
- “More subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz …
“Safety and effectiveness of emtricitabine/rilpivirine/tenofovir DF FDC have not been established in pediatric patients.”
The label will be available at the FDA Web site.
More information is available:
NIH Researchers Map Route for Eliciting HIV Neutralizing Antibodies
“Researchers have traced in detail how certain powerful HIV neutralizing antibodies evolve, a finding that generates vital clues to guide the design of a preventive HIV vaccine, according to a study appearing in Science Express this week. The discoveries were made by a team led by the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
“‘This elegant research brings us another step closer to an HIV vaccine and establishes a potent new technique for evaluating the human immune response to experimental vaccines, not only for HIV, but for pathogens generally,’ said NIAID Director Anthony S. Fauci, M.D.
“The new findings build on [last year’s discovery] reported by VRC scientists of three HIV antibodies, two of which could stop more than 90 percent of known global HIV strains ... from infecting human cells in the laboratory. Called VRC01, VRC02 and VRC03, these antibodies were found in blood donated for NIAID studies by an HIV-infected North American known as donor 45. In the new paper, scientists report discovering antibodies similar to VRC01 in the blood of two HIV-infected Africans known as donor 74 and donor 0219.
“The researchers further discovered that these VRC01-like antibodies all bind to the same spot on HIV in the same way. This suggests that an HIV vaccine should contain a protein replica of this spot, known as the CD4 binding site, to elicit antibodies as powerful as VRC01, according to the researchers. The CD4 binding site is one of the few parts of the continuously mutating virus that stays the same across HIV variants worldwide, and the virus uses this site to attach to the cells it infects.
“The scientists previously found that the genes for VRC01-like antibodies undergo an unusually high number of mutations—70 to 90—between the first draft that codes for a weak antibody and the final version that codes for an antibody that can neutralize HIV. These genes lie in the DNA of immune cells called B cells.
“‘To make a vaccine that elicits VRC01-like antibodies, we will need to coach B cells to evolve their antibody genes along one of several pathways, which we have now identified, from infancy to a mature, HIV-fighting form,’ said VRC Director Gary J. Nabel, M.D., Ph.D.”
More information is available:
Read the al instante E-Newsletter on Facebook
infoSIDA, the Spanish companion site of AIDSinfo, is pleased to expand its social media presence with a new al instante tab on Facebook. Al instante is the Spanish version of the At-A-Glance e-newsletter. Within the AIDSinfo Facebook page, click on the “al instante” tab on the left to gain access to the weekly Spanish e-newsletter.
The al instante tab has been created to provide an easy way for our Spanish-speaking Facebook users to read the Spanish e-newsletter every Wednesday. The newsletter features weekly news summaries about HIV/AIDS treatment, clinical trials, prevention, and ongoing research.
While in the tab, you can subscribe to al instante to receive the newsletter via e-mail. The al instante tab also provides access to the infoSIDA Web site, where you will find extensive HIV/AIDS resources in Spanish. It also has infoSIDA contact information and a link to Live Chat.
Questions or comments about the new al instante Facebook tab? Please call us at 1-800-448-0440, e-mail us at ContactUs@aidsinfo.nih.gov, or post on our Facebook wall.