Tenofovir

Trial finds tenofovir gel safe for daily use and most women adhered to study regimens

NEW DELHI, Feb. 25, 2008 A vaginal microbicide that incorporates an antiretroviral (ARV) drug normally used to treat people with HIV is safe for sexually active HIV-negative women to use every day over an extended period, suggest results of a clinical trial of tenofovir topical gel. Moreover, mos...

Mylan Announces Tentative FDA Approval Under PEPFAR for Tenofovir Disoproxil Fumarate Tablets

PITTSBURGH, Dec. 4 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL ) today announced that Matrix Laboratories Limited* has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Ap...

AIDS Sufferers Protest against Proposed Patent for Tenofovir

About 150 people which included some AIDS sufferers, held protests today against the proposed move of US biotech company to patent its anti-HIV drug, Tenofovir, in India. // The demonstrators alleged that this move could halt the local production of the generic equivalent. The company, Gilead...

President Clinton and Mylan Chairman and CEO Robert J. Coury Announce New Agreement to Lower Price of Treatment for Patients with Drug-Resistant HIV in Developing Countries

..., are making available all four drugs -- Atazanavir (ATV), Ritonavir (RTV), tenofovir (TDF), and Lamivudine (3TC) -- needed to enable once-daily treatment of pat...dard first-line ARVs. The four drugs will be available in three pills, with tenofovir and Lamivudine combined into a single pill. The three pills are being made ...

NCCN Updates Infection Guidelines to Include Information About H1N1 Virus (Swine Flu)

... the NCCN Guidelines include the addition of doripenem (Doribax(R), Ortho-McNeil-Janssen Pharmaceuticals, Inc.) to the Antibacterial Agents Tables and tenofovir disoproxil fumarate (Viread(R), Gilead Sciences, Inc.) to the Antiviral Agents Tables. NCCN Clinical Practice Guidelines in Oncology(TM) are d...

HIV integrase inhibitor effective for patients beginning antiretroviral treatment

...combined with two other standard retroviral drugs, tenofovir and emtricitabine. The trial included 566 patie...irenz or a protease inhibitor, in combination with tenofovir and emtricitabine, as a preferred drug regimen for... beginning antiretroviral treatment. Efavirenz, tenofovir and emtricitabine make up a once-a-day combination...

HIV prevention researchers to compare common ARV as a pill and vaginal gel in unique study

...ion people living with HIV/AIDS worldwide, the ARV tenofovir has particular promise because it can be formulate...N-001, seeks to understand how each formulation of tenofovir works in these infection-prone cells, information ...rence to and acceptance of three daily regimens of tenofovir ...

HIV Drug in Microbicide Gel Safe for Daily Use

...ay News) -- A vaginal microbicide gel that contains the antiretroviral drug tenofovir is safe for HIV-negative women to use every day, according to a six-month s... we can proceed with greater confidence on a path that will answer whether tenofovir gel and other gels with HIV-specific compounds will be able to prevent sexu...

Anti-HIV gel proven safe, tolerable for women

...hers said. The women study participants said if tenofovir gel is approved for the prevention of HIV infectio.... This sets the stage for larger studies to see if tenofovir can prevent HIV infection. The tenofovir Phase II trial results were presented Monday, Feb....

IPM Reaches Landmark Agreement with Pfizer to Develop FDA-Approved Antiretroviral Drug as Vaginal Microbicide

...develop CCR5 blocker and entry inhibitor compounds early in development, and in December 2006 IPM reached an agreement with Gilead Sciences to develop tenofovir (PMPA), a nucleoside reverse transcriptase inhibitor. HIV/AIDS ranks among the world's most devastating diseases because it has spread rapidly and...

Tenofovir in Medical Technology

New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FTC Revealed

CAPE TOWN, South Africa , July 20 /PRNewswire/ -- New data became available today at the 5(th) International AIDS Society Conference from ARTEN ( A tazanavir/ R itonavir on a background of T enofovir and E mtricitabine [Truvada(R)] versus N evirapine). ARTEN is an open-label, multi-c...

Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV

- Product Developed Through Joint Venture Between Bristol-Myers Squibb Company and Gilead Sciences, the First of Its Kind in HIV Treatment - PRINCETON, N.J. and FOSTER CITY, Calif., Oct. 17 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY ) and Gilead Sciences, Inc. (Nasd...

Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences

...nt-naive adult patients with HIV-1. Current HIV treatment guidelines issued by the U.S. Department of Health and Human Services list emtricitabine and tenofovir (the components of Truvada) in combination with a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor as a preferred regimen for pa...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

...as a single 30 mg tablet in combination with ritonavir-boosted atazanavir(2) is being compared to a control group receiving Truvada (emtricitabine and tenofovir disoproxil fumarate)(3) plus ritonavir-boosted atazanavir, which is a currently recommended option for first-line therapy. Atazanavir is a product in...

Analysis of Long-Term Vicriviroc Data Provides Evidence of Sustained Viral Suppression, Increased CD4 Cell Counts and Tolerability in Treatment-Experienced HIV-Infected Patients

...ates vicriviroc 30 mg once-daily in combination with ritonavir-boosted atazanavir,(6) compared to a control group receiving Truvada (emtricitabine and tenofovir disoproxil fumarate)(7) plus ritonavir-boosted atazanavir, which is a currently recommended option for first-line therapy. This novel nucleoside-spari...

Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults

...(or 400 mg/100 mg twice daily), each with a fixed dose of emtricitabine and tenofovir disoproxil fumarate. Results from the study, known as ARTEMIS, were prese... 400 mg/100 mg twice daily (n=346), plus a fixed-dose background regimen of tenofovir and emtricitabine once daily. Patient randomization was stratified based on...

Abbott's Kaletra(R) Tablet Dosed Once-Daily or Twice-Daily Demonstrated Similar Clinical Results Across Race and Gender Lines

...800 mg/200 mg once-daily tablet or 400/100 mg twice-daily tablet for eight weeks. All patients also received emtricitabine (FTC) 200 mg once-daily and tenofovir disoproxil fumarate 300 mg once-daily. At week eight, all patients receiving SGC were switched to the tablet formulation of Kaletra, matching their pr...

Ninety-Six Week Data on Tibotec Investigational NNRTI, TMC278, Presented at AIDS 2008

...r EFV, and all patients received a background regimen of two nucleoside reverse transcriptase inhibitors (NRTIs), zidovudine + lamivudine (AZT/3TC) or tenofovir + emtricitabine (TDF/FTC). Safety Results Of patients in the TMC278 combined group compared with EFV, 9 percent vs. 21 percent experienced rash, 3...

Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV

...when combined with a fixed background regimen consisting of emtricitabine + tenofovir disoproxil fumarate. A second phase III, double-blind randomized study, kno...ted background regimen consisting of two N[t]RTIs (abacavir + lamivudine or tenofovir disoproxil fumarate + emtricitabine or zidovudine + lamivudine). Each stu...

Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepatitis (ANRS)

... risks and uncertainties, including without limitation the risk that Clevudine will not demonstrate any additive antiviral benefit in combination with tenofovir in the head-to-head study, the risk that Clevudine will not demonstrate superiority over Hepsera in Clevudine's ongoing Phase 3 registration study, th...

Tenofovir in Biological News

New lab test offers better prediction of HIV microbicide safety

... The researchers later tested their model on two other microbicide candidates now being evaluated in large-scale clinical efficacy trials. Both drugs tenofovir and PRO 2000 performed well by not disrupting the epithelial barrier. "Our findings strongly suggest that microbicides can increase the risk of H...

Anti-HIV drug has potential to prevent transmission in women

...e multi-site study suggests that as a vaginal gel, tenofovir produced mild or no side effects in both HIV positive and HIV negative women. tenofovir is the active ingredient in the antiretroviral dru...ble that has been approved for widespread use. The tenofovir study was a safety and product acceptability study...

Careless reporting on HIV 'could cost lives'

...r in the online journal BMC International Health and Human Rights. Mills says that media reports were partly responsible for trials of the HIV drug tenofovir being cancelled in Cambodia in 2004 and in Cameroon earlier this year (see Cambodia's prime minister halts AIDS drug trial, and Cameroon suspends tria...

Why were the HIV prevention trials in commercial sex workers abandoned?

...gress of at least two important clinical trials of tenofovir as PREP and brought negative attention to tenofovi...angkok, Thailand last year against a PREP trial of tenofovir among Cambodian commercial sex workers caught the ...stics, McMaster University, Canada, argue that "if tenofovir is someday proven to be clinically efficacious as ...

Tenofovir in Biological Technology

Mylan's Matrix Selected by the Clinton HIV/AIDS Initiative and UNITAID as the Primary Supplier of Five Second-Line and Seven Pediatric HIV/AIDS Treatments

...etting them to those in need." Matrix's second-line products selected for the 2009 UNITAID-CHAI projects include heat-stable Lopinavir/Ritonavir, tenofovir and two fixed-dose combinations that use Tenofovir. The seven ARVs for which Matrix was selected under the UNITAID Pediatric Project include several f...

Mylan's Matrix Receives First Tentative FDA Approval Under PEPFAR for Generic Truvada(R)

...PFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg. Mylan Vice Chairman and CE...sion of our high-quality anti-retroviral franchise." Emtricitabine and tenofovir Disoproxil Fumarate Tablets are the generic version of Gilead Sciences Inc....