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Gilead Sciences gets FDA approval for once-daily single tablet HIV-1 regimen Complera

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens in the United States.

13 Dec 2013

Researchers launch phase II clinical trial of rectal microbicide to prevent HIV infections

Taking an important step toward the development of a product to prevent HIV infections associated with unprotected anal sex, researchers today announced the launch of a global Phase II clinical trial of a potential rectal microbicide.

3 Oct 2013

Experts address ethical issues raised by FDA's approval of Truvada for HIV prevention

The Food and Drug Administration's approval last year of the drug Truvada for prevention of HIV infection was a milestone in the fight against HIV/AIDS, but experts are cautioning that it is only the beginning of new ethical concerns for health care professionals, policy makers, researchers and those taking Truvada to prevent HIV infection.

1 Aug 2013

Quest Diagnostics completes sale of ibrutinib commercialization rights to Royalty Pharma

Quest Diagnostics Incorporated, the world's leading provider of diagnostic information services, announced today that it has completed the sale of its rights to royalties from commercialization of the drug candidate ibrutinib to Royalty Pharma, the industry leader in acquiring royalty interests in marketed and late stage biopharmaceutical products, for $485 million in cash.

From Quest Diagnostics 18 Jul 2013

Reformulated version of anti-HIV gel safe for HIV-negative men and women

A reformulated version of an anti-HIV gel developed for vaginal use was found safe and acceptable by HIV-negative men and women who used it rectally, according to a Phase I clinical trial published today in PLOS ONE.

4 Apr 2013

Women's low adherence to daily-dose products in HIV prevention trial suggest different approach needed, researchers say

"Results of a major HIV prevention trial suggest that daily use of a product -- whether a vaginal gel or an oral tablet -- does not appear to be the right approach for preventing HIV in young, unmarried African women," a press release from the Microbicide Trials Network reports.

6 Mar 2013

Study finds antiretroviral-based strategies to prevent HIV infection among women prove ineffective

Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa.

5 Mar 2013

Gilead Sciences fourth quarter total revenues increase 18% to $2.59 billion

Gilead Sciences, Inc. announced today its results of operations for the fourth quarter and full year 2012.

5 Feb 2013

Encouraging results from Gilead’s TAF Phase 2 trial on HIV-1 infection

Gilead Sciences, Inc. today announced that a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate, an investigational novel prodrug of tenofovir for the treatment of HIV-1 infection, met its primary objective.

1 Nov 2012

Study estimates drug concentrations of Truvada and tenofovir to reduce risk of HIV among MSM

Several large clinical trials have demonstrated that a daily oral dose of one or two antiretroviral drugs used to treat HIV infection can prevent infection in an approach known as pre-exposure prophylaxis, or PrEP.

15 Sep 2012

FDA approves Gilead’s Stribild to treat HIV-1 infection

The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.

28 Aug 2012

Gilead Sciences receives FDA approval for Stribild to treat HIV-1 infection

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.

28 Aug 2012

Gilead Sciences signs deals with 3 Indian pharmaceutical companies to promote low-cost HIV drugs in developing countries

Gilead Sciences Inc. announced Thursday that it plans to partner with Mylan Inc., Ranbaxy Laboratories Ltd. and Strides Arcolab Ltd. "to promote access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine in developing countries," the Wall Street Journal reports.

3 Aug 2012

Mylan licenses rights to produce and market generic versions of Gilead HIV/AIDS therapies

Mylan Inc. today announced the establishment of a new agreement between its subsidiary Mylan Laboratories Limited and Gilead Sciences Inc. Under this agreement, Mylan has licensed the rights to produce and market generic versions of Gilead HIV/AIDS therapies containing Emtricitabine, including single and fixed-dose combinations.

3 Aug 2012

GlobalPost examines debate surrounding PrEP

GlobalPost's "Global Pulse" blog examines questions surrounding the use of the antiretroviral Truvada for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among people at high risk, as studies released and panel discussions held last week at the XIX International AIDS Conference (AIDS 2012) "raised concerns about the drug's effect on the future of the AIDS fight."

31 Jul 2012

Views on AIDS: More funding will be needed for new attack on HIV; The epidemic hits hard in the South

The international AIDS conference in Washington has already made two points clear. There is no prospect that scientists will any time soon find the ultimate solutions to the AIDS epidemic, namely a vaccine that would prevent infection with the AIDS virus or a "cure" for people already infected with the virus.

31 Jul 2012

Gilead Sciences second quarter total revenues increase 13% to $2.41 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2012.

26 Jul 2012

Merck signs two licensing agreements for investigational HIV drug candidates

Merck, known as MSD outside the United States and Canada, announced today that the company has signed two licensing agreements for investigational HIV drug candidates.

25 Jul 2012

Dapivirine Phase III trial now underway in Africa to treat HIV in women

A large clinical trial testing the long-term safety and effectiveness of a new approach for preventing HIV in women - a vaginal ring used once a month - is now underway in Africa, researchers announced today at the XIX International AIDS Conference (AIDS 2012).