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
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
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.
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
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.
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
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.
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
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
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
EFV, and all patients received a background regimen of two nucleoside
reverse transcriptase inhibitors (NRTIs), zidovudine + lamivudine (AZT/3TC)
+ emtricitabine (TDF/FTC).
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
fumarate. A second phase III, double-blind randomized study, kno...ted background regimen
consisting of two N[t]RTIs (abacavir + lamivudine or tenofovir
fumarate + emtricitabine or zidovudine + lamivudine).
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