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FDA: More Than 150 Antiretroviral Drugs Available Through PEPFAR for Worldwide HIV/AIDS Relief

Posted 23 Jul 2012 by Drugs.com

July 23, 2012 – 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. The most recent FDA actions in association with PEPFAR were tentative approvals of the following generic drugs: abacavir oral solution (Hetero Labs Ltd. Unit III, July 2, 2012) lopinavir and ritonavir oral solution (Cipla Ltd., June 29, 2012) efavirenz tablets (Edict Pharmaceuticals Private Ltd., June 25, 2012 and Micro Labs Ltd., June 20, 2012) Tentative approval means that although FDA has found that a drug product has met all required manufacturing quality, clinical safety, and efficacy requirements, it cannot be a ... Read more

Related support groups: HIV Infection, Atripla, Incivek, Victrelis, Baraclude, Viread, Kaletra, Tenofovir, Telaprevir, Norvir, Nevirapine, Lexiva, Entecavir, Lamivudine, Reyataz, Hepsera, Prezista, Ritonavir, Norvir Soft Gelatin, Boceprevir

FDA MedWatch - Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack

Posted 2 Mar 2011 by Drugs.com

Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack including Ziagen, Trizivir, and Epzicom AUDIENCE: Infectious Disease ISSUE: FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer. FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any ... Read more

Related support groups: Trizivir, Abacavir, Epzicom, Ziagen, Abacavir/Lamivudine/Zidovudine, Abacavir/Lamivudine

Anti-HIV Drugs May Help Prevent Spread of Virus

Posted 27 May 2010 by Drugs.com

THURSDAY, May 27 – People who are HIV-positive can lower their risk for transmitting the virus to their partners by 90 percent by taking antiretroviral drugs, new research has found. Antiretroviral drug therapy helps reduce HIV levels in the infected person's blood, which in turn makes the person less infectious to others. The drugs are commonly taken in the United States by people with HIV, the virus that causes AIDS. In the new research, published online May 26 in The Lancet, investigators studied more than 3,400 heterosexual couples in seven African countries. In each couple, one person was infected with HIV and the other was not. No one in the study was taking antiretroviral drugs. Health workers counseled the couples about preventing HIV transmission and followed up with them for two years. During that time, periodic blood tests measured HIV levels in the blood, and people were ... Read more

Related support groups: HIV Infection, Atripla, Truvada, Baraclude, Viread, Tenofovir, Kaletra, Norvir, Nevirapine, Reyataz, Lexiva, Lamivudine, Entecavir, Ritonavir, Norvir Soft Gelatin, Epivir, Hepsera, Combivir, Prezista, Isentress

FDA Medwatch Alert: Abacavir (marketed as Ziagen) and Abacavir-containing Medications

Posted 24 Jul 2008 by Drugs.com

[Posted 07/24/2008] FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.[July 24, 2008 - Information for Healthcare Professionals - FDA] Read more

Related support groups: Trizivir, Epzicom, Ziagen

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