Truvada News and Research

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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

Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Tibotec Pharmaceuticals today announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed indication would make TMC278 available for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults.

3 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.

26 Jul 2010

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.

23 Jul 2010

New HIV drug on the block

Johnson and Johnson’s experimental HIV drug rilpivirine or TMC278, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS. Two clinical trials with the drug has shown that although its effectiveness was same as the existing anti-HIV drugs, its side effects were fewer. On the flip side nearly twice as many patients failed to respond to treatment with the new drug.

22 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2010. Total revenues for the second quarter of 2010 were $1.93 billion, up 17 percent compared to total revenues of $1.65 billion for the second quarter of 2009. Net income for the second quarter of 2010 was $712.1 million, or $0.79 per diluted share, compared to net income for the second quarter of 2009 of $571.4 million, or $0.61 per diluted share.

21 Jul 2010

Tenofovir gel reduces HIV by 39% in women: CAPRISA 004 study

Researchers who conducted a study testing a vaginal microbicide with an antiretroviral (ARV) drug called tenofovir found its use before and after sex was significantly more protective against HIV infection than a placebo gel among women at high risk of HIV. Results of the study, known as CAPRISA 004, are to be reported at the International AIDS Conference (AIDS 2010) in Vienna and published online by the journal Science.

20 Jul 2010