Latest Emtricitabine Stories
Oral tenofovir discontinued in clinical trial A large-scale clinical trial evaluating whether daily use of an oral tablet or vaginal gel containing antiretroviral drugs can prevent HIV infection in women is being modified because an interim review found that the study cannot show that one of the study products, oral tenofovir, marketed under the trade name Viread, is effective. An independent data and safety monitoring board (DSMB) recommended that the Vaginal and Oral Interventions to...
TITUSVILLE, New Jersey, September 23, 2011 /PRNewswire/ -- - Third HIV medication submitted by Tibotec - Tibotec Pharmaceuticals (Tibotec), one of the Janssen Pharmaceutical Companies, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of EDURANT(R) (rilpivirine), a 25 mg tablet, as a once-daily treatment in combination with other antiretroviral agents...
TITUSVILLE, N.J., July 19, 2011 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor (NNRTI) EDURANT(TM) (rilpivirine) tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults. The pooled analysis at 96 weeks showed that 78 percent of...
A special press conference at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) will today feature a panel consisting of researchers from the CDC TDF2 study, the Partners PrEP Study and the HPTN 052 study. They will be joined by Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), Gottfried Hirnschall, Director of the HIV Department of the World Health Organization (WHO) and Elly Katabira, IAS 2011 International Chair and...
PITTSBURGH and HYDERABAD, India, July 12, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced an expanded licensing agreement between Gilead Sciences Inc. and Mylan's Matrix Laboratories Limited. Matrix has licensed the rights to produce and market generic versions of three Gilead HIV/AIDS therapies, if and when they receive regulatory approval. The Gilead products, which are currently in late-stage clinical development, include: Elvitegravir, an investigational integrase...
CORK, Ireland, June 28, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals today announced that it has entered into a license agreement with Gilead Sciences, Inc., for the development and commercialization of a new once-daily single tablet fixed-dose antiretroviral combination product containing Tibotec's protease inhibitor PREZISTA® (darunavir) and Gilead's cobicistat, an investigational pharmacoenhancing or "boosting" agent. PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), and...
TITUSVILLE, N.J., May 20, 2011 /PRNewswire/ -- The US Food and Drug Administration (FDA) today approved EDURANT(TM) (rilpivirine) tablets for use in combination with other antiretroviral agents (ARVs) in the treatment of human immunodeficiency virus type 1 (HIV-1) in adults who have never taken HIV therapy (treatment-naive). (Photo: http://photos.prnewswire.com/prnh/20110520/SF06258) EDURANT (pronounced ee' dur ant) was developed as TMC278 (rilpivirine) by Tibotec Pharmaceuticals and is...
The first human studies of an oral drug regimen to prevent HIV infection in high-risk individuals yielded a promising near 50% reduction in HIV incidence, but a number of issues require additional research before oral pre-exposure prophylaxis (PrEP) can be implemented on a large scale, according to an article in AIDS Patient Care and STDs, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). The article is available free online at www.liebertpub.com/apcAfter the...
Preferences for HIV prevention products differ among US and African womenIn the first study to make head-to-head comparisons between tenofovir gel and oral tenofovir "“ two promising approaches for preventing HIV in women "“ researchers found that daily use of the vaginal gel achieved a more than 100-times higher concentration of active drug in vaginal tissue than did the oral tablet, while, compared to the gel, the tablet used daily was associated with a 20-times higher active drug...
CORK, Ireland, Jan. 27, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the...
