Truvada News and Research

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Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

At the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston on Monday, researchers "suggested the potential" of a gel containing the antiretroviral drug tenofovir to reduce the risk of anal HIV transmission, TIME's "Healthland" blog reports.

2 Mar 2011

Tenofovir gel more effective than oral tablet for HIV treatment: Study

In 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 concentration in blood.

1 Mar 2011

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

10 Feb 2011

Tibotec grants multiple non-exclusive licenses to generic manufacturers for rilpivirine hydrochloride

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 treatment of treatment-naive HIV-1 infected adults.

28 Jan 2011

Ramius/RP Group extend tender offer to acquire Cypress Bioscience

Ramius V&O Acquisition LLC, affiliates of Ramius LLC (collectively, "Ramius") and affiliates of Royalty Pharma (together with Ramius and Purchaser, the "Ramius/RP Group") announced today that the Ramius/RP Group is extending its previously announced tender offer to acquire all of the outstanding shares of common stock of Cypress Bioscience, Inc., a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system (CNS) disorders, until Midnight, January 5, 2011, unless the offer is otherwise extended.

22 Dec 2010

Opinions: Obama's Global Fund pledge; harm reduction in Iran; HIV prevention; African development

There are some encouraging signs in the epic battle against AIDS and HIV infections. But those bright spots dim considerably in the face of the fact that about 7,100 people a day become infected.

30 Nov 2010

To reduce spread of HIV/AIDS, IFRC calls for more focus on IDU programs

Ahead of World AIDS Day, the International Federation of the Red Cross on Friday released a report (.pdf) calling for governments around the world to do more to help stop the spread of HIV/AIDS among populations of injecting drug users (IDUs), the Associated Press reports (Heilprin, 11/25).

30 Nov 2010

Media outlets continue to follow major HIV/AIDS developments this week

Media outlets continued to track the major developments in HIV/AIDS this week, including: prevention research using an antiretroviral; new UNAIDS estimates of HIV/AIDS around the world; and Pope Benedict XVI's stance on condoms for HIV prevention.

25 Nov 2010

New drug research, incidence rates and Pope's comments brighten AIDS outlook

The Associated Press: "In the nearly 30 years the AIDS epidemic has raged, there has never been a more hopeful day than this. Three striking developments took place Tuesday: U.N. officials said new HIV cases are dropping dramatically worldwide. A study showed that a daily pill already on pharmacy shelves could help prevent new infections in gay men. And the pope opened the way for the use of condoms to prevent AIDS" (Marchione, 11/23).

25 Nov 2010

FTC/TDF tablet reduces HIV infection among high-risk individuals: iPrEx study

In a finding with the potential to fundamentally change strategies to slow the global HIV epidemic, a new study called iPrEx shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir (FTC/TDF), experienced an average of 43.8% fewer HIV infections than those who received a placebo pill. New England Journal of Medicine, is the first evidence that this new HIV prevention method, called pre-exposure prophylaxis or PrEP, reduces HIV infection risk in people.

24 Nov 2010

Important queries about PrEP, iPrEx trial for HIV infection

The results of the iPrEx PrEP effectiveness trial of once-daily TDF/FTC (brand name Truvada) in gay men, transgender women and other men who have sex with men are a landmark in HIV prevention research.

24 Nov 2010

HIV treatment drugs also help prevent HIV infection in high-risk men: Study

In a significant advance for HIV prevention research, a clinical trial confirms that the same drugs used for treating HIV can also help prevent HIV infection in the first place.

24 Nov 2010

iPrEx study: PrEP reduces HIV infection risk among gay, bisexual men

A daily dose of an oral antiretroviral drug, currently approved to treat HIV infection, reduced the risk of acquiring HIV infection by 43.8 percent among men who have sex with men.

24 Nov 2010

iPrEx trial shows reduction in new HIV infections

Results of the world's first efficacy trial of an HIV-prevention approach called oral pre-exposure prophylaxis, or PrEP, were released online in the New England Journal of Medicine today.

24 Nov 2010

iPrEx oral PrEP study achieves major milestone in HIV prevention research

This is a great day in the fight against AIDS. The positive results of the iPrEx oral PrEP study are a major milestone in HIV prevention research and provide important information about how antiretroviral drugs might be used for prevention by HIV-negative people at high risk for HIV infection, said AVAC Executive Director Mitchell Warren.

24 Nov 2010

Daily oral antiretroviral reduces HIV infection risk in MSM by 44%, study finds

A study that included nearly 2,500 HIV-negative men and transgender women who have sex with men has shown that a daily dose of Truvada, a pill containing the AIDS drugs emtricitabine and tenofovir, "can reduce risk of contracting [HIV] by an average of 44% - and by more than 70% if the subjects" follow the regimen closely, Los Angeles Times reports (Maugh, 11/23).

24 Nov 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

Gilead Sciences, Inc. today announced new data from the open-label phase of two pivotal Phase III clinical trials (Studies 102 and 103) evaluating the four-year efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection.

1 Nov 2010

Gilead Sciences third quarter total revenues increase 8% to $1.94 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended September 30, 2010. Total revenues for the third quarter of 2010 were $1.94 billion, up 8 percent compared to total revenues of $1.80 billion for the third quarter of 2009. Net income for the third quarter of 2010 was $704.9 million, or $0.83 per diluted share, compared to net income for the third quarter of 2009 of $673.0 million, or $0.72 per diluted share.

20 Oct 2010

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010