Zidovudine News and Research

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Zidovudine was approved by the FDA on March 19, 1987, with other antiretroviral agents for the treatment of HIV infection in adults and in children 3 months of age or older. This medicine is also approved for use in HIV infected women to prevent the virus from being passed to their babies during pregnancy and delivery. It is then given to these babies for the first 6 weeks of life. Although the FDA does not approve this practice, zidovudine may be used to prevent workers from getting HIV infection after they accidentally come into contact with the virus on the job. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.

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.

27 Jan 2012

Gilead Sciences receives FDA approval for Viread to treat pediatric HIV infection

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Viread in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.

19 Jan 2012

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:

20 Dec 2011

Brazil's ANVISA grants registration for child-adapted formulation of benznidazole for Chagas disease

Today, at the occasion of the 4th DNDi Partners' Meeting in Rio de Janeiro, Brazil, Dr Carlos Gadelha, Secretary of Science, Technology and Strategic Products, Brazilian Ministry of Health, announced that Brazil's National Health Surveillance Agency (ANVISA) granted registration of a new paediatric dosage form of benznidazole, developed through a partnership between the Pernambuco State Pharmaceutical Laboratory (LAFEPE) of Brazil and the Drugs for Neglected Diseases initiative (DNDi).

3 Dec 2011

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.

11 Aug 2011

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.

20 Jul 2011

Infants treated with certain HIV medication more likely to experience adrenal dysfunction

Infants of human immunodeficiency virus 1 (HIV-1) infected mothers who were treated before and after birth with the protease inhibitor lopinavir-ritonavir were more likely to experience adrenal dysfunction, including life-threatening adrenal insufficiency in premature infants, compared with a zidovudine-based regimen, according to a preliminary report in the July 6 issue of JAMA.

6 Jul 2011

HIV drug linked to accelerated and early aging

New research published this Sunday reveals that a class of generic AIDS drugs often used to treat HIV in Africa and other poor regions can cause premature aging and lead to age-related illnesses such as heart disease and dementia.

27 Jun 2011

Some HIV drugs can cause premature ageing

A class of anti-retroviral drugs commonly used to treat HIV, particularly in Africa and low income countries, can cause premature ageing, according to research published today in the journal Nature Genetics. The study shows that the drugs damage DNA in the patient's mitochondria - the 'batteries' which power their cells.

27 Jun 2011

Study shows possibility of women living with AIDS to breastfeed with lower risk

In low-income countries, 1.4 million women are living with the Aids virus. If no prevention measures are taken, the risk for future mothers of transmitting HIV to their child in utero, during delivery or when breastfeeding is 35%.

20 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

FDA approves Matrix NDA for Zidovudine Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Zidovudine Tablets, 100 mg.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

HIV prevention, treatment highlighted at Conference on Retroviruses and Opportunistic Infections

Today was the last day of the 18th Conference on Retroviruses and Opportunistic Infections, a key HIV/AIDS research meeting being held at the Hynes Convention Center in Boston from February 27 through March 2. Highlighted below are selected presentations from March 2nd on research supported by the National Institute of Allergy and Infectious Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, both components of the National Institutes of Health.

5 Mar 2011

Pediatrician unveils latest findings of IMPAACT HIV/AIDS study during 2011 CROI

A clinical study of anti-HIV/AIDS medicines in the developing world is on the verge of turning "the whole treatment world on its head," according to Dartmouth pediatrician Paul Palumbo.

4 Mar 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

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

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 Lamivudine and Zidovudine Tablets, 30 mg/60 mg.

20 Jan 2011

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

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