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FDA approves sNDA for SUSTIVA for treatment of HIV-1 infected pediatric patients

FDA approves sNDA for SUSTIVA for treatment of HIV-1 infected pediatric patients

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg. [More]
Reformulated version of anti-HIV gel safe for HIV-negative men and women

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. [More]

Indonesia to issue compulsory licenses for HIV, hepatitis B drugs still under patent

"The Indonesian government hopes to implement one of the largest ever examples of 'compulsory licensing,' which will enable the generic manufacture of drugs still under patent," IRIN reports. [More]
Patients with drug-resistant HIV can safely achieve viral suppression without NRTIs

Patients with drug-resistant HIV can safely achieve viral suppression without NRTIs

A new multi-site study reveals patients with drug-resistant HIV can safely achieve viral suppression - the primary goal of HIV therapy - without incorporating the traditional class of HIV medications into their treatment regimen. [More]

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. [More]

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. [More]
HCV and HIV co-infected patients achieve early treatment success with faldaprevir, PegIFN/RBV

HCV and HIV co-infected patients achieve early treatment success with faldaprevir, PegIFN/RBV

Interim study results from STARTversoTM 4 presented today at CROI+ show that 80 percent of hepatitis C (HCV) patients also infected with HIV achieved early treatment success with faldaprevir (BI 201335) combined with pegylated interferon and ribavirin (PegIFN/RBV). [More]

Gilead to resolve Viread patent litigation case with Teva

Gilead Sciences, Inc. today announced that Gilead and Teva Pharmaceuticals have reached an agreement in principle to settle the ongoing patent litigation concerning the patents protecting Viread (tenofovir disoproxil fumarate), a treatment for HIV infection and chronic hepatitis B. Under the terms of the settlement, Teva will be allowed to launch a generic version of Viread on December 15, 2017. [More]
Gilead Sciences fourth quarter total revenues increase 18% to $2.59 billion

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. [More]

Gilead commences first of two tenofovir alafenamide Phase 3 trials in HIV

Gilead Sciences, Inc. today announced the initiation of the first of two Phase 3 clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults. [More]

IRMA, Population Council and MTN release Rectal Revolution video project

International Rectal Microbicide Advocates (IRMA), the Population Council, and the Microbicide Trials Network (MTN) today released a collaborative video project called "The Rectal Revolution Is Here: An Introduction to Rectal Microbicide Clinical Trials." The jointly produced video, the first of its kind, is designed to educate communities affected by HIV about rectal microbicide development and the importance of participating in clinical trials to help speed the search for new HIV prevention options. [More]
Long-term antiviral HBV treatment advocated

Long-term antiviral HBV treatment advocated

Study results support the long-term use of tenofovir disoproxil fumarate for chronic hepatitis B virus, showing that it can suppress the virus and lead to regression of fibrosis and cirrhosis in patients after 5 years’ treatment. [More]

Janssen announces U.S. prescribing information update for EDURANT tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies, which evaluated the efficacy and safety of EDURANT for the treatment of human immunodeficiency virus type 1 (HIV-1) in antiretroviral treatment-naive adults. [More]

IQWiG investigates benefits of rilpivirine for HIV treatment

Since the start of 2012, a new drug called rilpivirine has been available for adult patients infected with the human immunodeficiency virus type 1 (HIV-1). It is marketed by two different pharmaceutical companies, by one as a single agent (trade name Edurant-) and by the other as a fixed combination with other HIV drugs (trade name Eviplera-). [More]
Tenofovir DF safe and effective in treating adolescents with HBV

Tenofovir DF safe and effective in treating adolescents with HBV

A recent clinical trial found that the adult antiviral drug, tenofovir disoproxil fumarate (tenofovir DF), is safe and effective in treating adolescents with hepatitis B virus (HBV). Trial results published in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases (AASLD), show that tenofovir DF suppressed HBV in 89% of pediatric participants. [More]

Gilead Sciences receives EC approval for Viread to treat HIV-1 infected children

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread (tenofovir disoproxil fumarate). [More]

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. [More]
Researchers discover how HIV-infected people develop very powerful antibody responses

Researchers discover how HIV-infected people develop very powerful antibody responses

Wits researchers have played a pivotal role in an AIDS study published today in the journal, Nature Medicine, which describes how a unique change in the outer covering of the virus found in two HIV infected South African women enabled them to make potent antibodies which are able to kill up to 88% of HIV types from around the world. [More]

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. [More]
FDA approves Gilead’s Stribild to treat HIV-1 infection

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. [More]