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European Commission approves BMY's BARACLUDE(r) to treat CHB in adult patients with liver disease

Bristol-Myers Squibb announced today that BARACLUDE(R) has been approved by the European Commission on February 28th 2011 to treat chronic hepatitis B in adult patients with evidence of decompensated liver disease.

1 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

Anti-AIDS gel shows promise

Dr. Ian McGowan, a professor of medicine at the University of Pittsburgh who is leading a second-phase study of the gel said, “These are early results, but [they] help set the stage for current and future trials of rectal microbicides and the development of a rectal-specific formulation of tenofovir gel.” Researchers have focused on the use of microbicides such as tenofovir, as a preventive treatment to be used in vaginal sex. However, scientists think unprotected anal sex is much more risky.

1 Mar 2011

Tenofovir gel may help reduce risk of HIV from anal sex

A gel developed to protect against HIV during vaginal sex produced a strong antiviral effect when used in the rectum, according to an early-phase study presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI). The results, based on rectal tissue biopsies sampled from HIV-negative men and women who used the product daily for one week, provide the first-ever evidence that tenofovir gel could help reduce the risk of HIV from anal sex, even though the vaginal gel formulation may not be optimal for rectal use.

28 Feb 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

Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV

Shionogi-ViiV Healthcare, LLC announced today that the first patient has entered the clinical study, SINGLE (ING114467), designed to support a new fixed-dose combination (FDC) therapy for the treatment of HIV.

3 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

Matrix enters licensing agreement with Tibotec for generic Rilpivirine Hydrochloride

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has signed an agreement with Tibotec Pharmaceuticals for a non-exclusive license to manufacture, market and distribute a generic version of the non-nucleoside reverse transcriptase inhibitor Rilpivirine Hydrochloride (TMC278), pending its regulatory approval for the treatment of treatment-naive HIV-1-infected adults.

28 Jan 2011

Earlier ART initiation should be highest priority for global expansion of HIV patient care

Earlier initiation of antiretroviral therapy should be the highest priority for global expansion of HIV patient care. This finding, from a paper published in this week's PLoS Medicine, should help resource-limited nations to phase in the implementation of the new 2010 WHO recommendations for HIV treatment. "Immediate scale-up of the entire WHO guideline package may be prohibitively expensive in some settings," said lead author Rochelle P. Walensky, MD, MPH of the Massachusetts General Hospital, Boston, USA.

22 Dec 2010

Chimerix reports positive results from CMX157 Phase 1 clinical trial for HIV

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced first-in-human Phase 1 clinical trial results for CMX157 demonstrating a favorable safety, tolerability and drug distribution profile.

14 Dec 2010

Goosby, Emanuel address progress, potential roadblocks ahead for introduction of microbicides in developing countries

The growing evidence supporting the promise of new HIV prevention products, like microbicides, requires that groups start planning now for how best to roll-out prevention interventions in the future, U.S. Global AIDS Coordinator Eric Goosby and Special Advisor on Health Policy to the Director of the White House Office of Management and Budget Ezekiel Emanuel said Monday during a USAID Microbicide Stakeholders Meeting in Washington.

30 Nov 2010

Merck announces initial results from ISENTRESS Phase III study in HIV-1

Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.

29 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

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

GCM supports iPrEx Study to prevent HIV infection among MSM

The Global Campaign for Microbicides (GCM) welcomes today's news from the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Disease (NIAID) of the US National Institutes of Health (NIH) and the Gladstone Institutes of the University of California, San Francisco that daily use of oral emtricitabine (FTC) with tenofovir (TDF) in one tablet shows promise to safely and effectively help to prevent HIV infection among men who have sex with men (MSM).

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