Abacavir News and Research RSS Feed - Abacavir News and Research

Abacavir sulfate, also known as Ziagen or ABC, is a type of medicine called a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs block reverse transcriptase, a protein that HIV needs to make more copies of itself.
GlaxoSmithKline's HIV/AIDS business joins Medicines Patent Pool

GlaxoSmithKline's HIV/AIDS business joins Medicines Patent Pool

"GlaxoSmithKline's HIV/AIDS drugs business is to share intellectual property rights on children's medicine in a patent pool designed to make treatments more widely available in poor countries," Reuters reports. [More]
Janssen announces U.S. prescribing information update for EDURANT tablets

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]

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. [More]
FDA approves 152 antiretroviral drugs in association with PEPFAR to treat HIV/AIDS

FDA approves 152 antiretroviral drugs in association with PEPFAR to treat HIV/AIDS

Today, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic. [More]
All adult patients with HIV should be offered ART: International Antiviral Society-USA panel

All adult patients with HIV should be offered ART: International Antiviral Society-USA panel

Included in the 2012 International Antiviral Society-USA panel recommendations for human immunodeficiency virus (HIV) patient care is that all adult patients, regardless of CD4 cell count, should be offered antiretroviral therapy (ART), according to an article in the July 25 issue of JAMA, a theme issue on HIV/AIDS. [More]
Cipla, DNDi to develop ARV combination therapy for children with HIV/AIDS

Cipla, DNDi to develop ARV combination therapy for children with HIV/AIDS

On the eve of the XIX International AIDS Conference in Washington, DC, the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, announces a new collaboration with Indian drug manufacturer Cipla to develop and produce an improved first-line antiretroviral (ARV) combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV/AIDS. [More]
Dolutegravir-based regimen demonstrates superiority over Atripla in treatment-naive adults with HIV-1

Dolutegravir-based regimen demonstrates superiority over Atripla in treatment-naive adults with HIV-1

Shionogi-ViiV Healthcare LLC today announced that initial results have been received from the Phase III SINGLE (ING114467) study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1. [More]
Researchers identify mechanism key in drug allergy

Researchers identify mechanism key in drug allergy

Adverse drug reactions are a major issue that cause harm, are costly and restrict treatment options for patients and the development of new drugs. A groundbreaking finding by researchers from the La Jolla Institute for Allergy & Immunology could lead to a new way to dramatically improve drug safety by identifying drugs at risk to cause potentially fatal genetic-linked hypersensitivity reactions before their use in man. [More]

Severe hypersensitivity reactions to anti-HIV drug occur through autoimmune mechanism

Potentially severe hypersensitivity reactions to the anti-HIV drug abacavir occur through an autoimmune mechanism, resulting from the creation of drug-induced immunogens that are attacked by the body's immune system, according to a study published online by the journal AIDS, official journal of the International AIDS Society. [More]

Researchers identify new mechanism for drug-related autoimmune reactions

A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions. [More]

ViiV, Shionogi announce initial results from dolutegravir Phase III study on HIV-1

ViiV Healthcare and Shionogi & Co., Ltd. today announced that initial results have been received from the SPRING-2 (ING113086) Phase III study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1. [More]
Study explores links between antiretroviral prophylaxis, cleft lip and palate

Study explores links between antiretroviral prophylaxis, cleft lip and palate

HIV-positive mothers have been able to guard against transmitting the disease to their babies by taking antiretroviral drugs during pregnancy. Although the drugs prevent children from being born with HIV, they could cause birth defects, such as cleft lip and palate. A new study explores any links between antiretroviral prophylaxis and cleft lip and palate. [More]

WHO approves three Mylan ARV therapies to treat HIV/AIDS

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received approval for three antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization's (WHO) Prequalification of Medicines Programme. The products include: [More]
FDA approves Gilead's Complera for treatment of HIV-1 infection

FDA approves Gilead's Complera for treatment of HIV-1 infection

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Complera, a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. [More]
Janssen presents EDURANT 96-week Phase 3 trial data at International AIDS Society Conference

Janssen presents EDURANT 96-week Phase 3 trial data at International AIDS Society Conference

Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor EDURANT tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults. [More]
NHGRI's new strategic plan to identify genetic bases of most single-gene disorders

NHGRI's new strategic plan to identify genetic bases of most single-gene disorders

A new strategic plan from an arm of the National Institutes of Health envisions scientists being able to identify genetic bases of most single-gene disorders and gaining new insights into multi-gene disorders in the next decade. This should lead to more accurate diagnoses, new drug targets and the development of practical treatments for many who today lack therapeutic options, according to the plan from the National Human Genome Research Institute (NHGRI). [More]
Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV

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. [More]

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare. [More]
Merck announces initial results from ISENTRESS Phase III study in HIV-1

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. [More]

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. [More]