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Plan On New HIV Kits - AllAfrica.com

clarke — Fri, 10 Feb 2012 13:19:57 +0000

Plan On New HIV Kits - AllAfrica.com - Plan On New HIV KitsAllAfrica.comTHE Ministry of Health and Social Welfare is working on guidelines for procurement of new types of HIV/AIDS test kits. New kits need to be procured for Tanzania market following the withdrawal last month of the then Standard Diagnostics BiolineÂ® HIV ... [Google HIV NEWS]

FDA: Tenative approval of lamivudine, nevirapine, and zidovudine fixed dose combination / PEPFAR (AEGiS.org)

clarke — Fri, 10 Feb 2012 13:14:32 +0000

FDA: Tenative approval of lamivudine, nevirapine, and zidovudine fixed dose combination / PEPFAR (AEGiS.org) - Tenative approval of lamivudine, nevirapine, and zidovudine fixed dose combination / PEPFAR
Food and Drug Administration - February 8, 2012 Richard Klein & Kimberly Struble
http://www.aegis.org/news/fda/2012/FD120201.html

On February 8, 2012, the Food and Drug Administration granted tentative approval for a fixed dose combination tablet containing lamivudine, nevirapine, and zidovudine, 150 mg/200 mg/300 mg, indicated for use alone or in combination with other antiretrovirals for the treatment of HIV-1 infection.
"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the PEPFAR program.
The product is manufactured by Macleods Pharmaceuticals Limited of Mumbai, India, and was reviewed under the FDA guidance titled Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV, developed to clarify the regulatory requirements that apply to such applications, possible issues of concern, and how they should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA..
You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration 120208 FD120201

SOURCE: Food and Drug Administration (FDA).
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 2012. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2012. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. [AEGiS]

Tanzania: Plan On New HIV Kits

clarke — Fri, 10 Feb 2012 13:13:30 +0000

Tanzania: Plan On New HIV Kits - [Daily News]

THE Ministry of Health and Social Welfare is working on guidelines for procurement of new types of HIV/AIDS test kits. [All Africa.com

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Zimbabwe: Disclosure - a Difficult Road to Traverse

clarke — Fri, 10 Feb 2012 13:13:01 +0000

Zimbabwe: Disclosure - a Difficult Road to Traverse - [The Herald]

DISCLOSURE is a process and some people have found it a difficult road to traverse after testing HIV positive. HIV, unlike other medical conditions, is treated with shame and disdain by society as it is stereotyped as a condition for those with loose morals. [All Africa.com

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Angola: Pregnant Women Join HIV/Aids Test

clarke — Fri, 10 Feb 2012 13:12:40 +0000

Angola: Pregnant Women Join HIV/Aids Test - [ANGOP]
Caxito -
At least 642 pregnant women in the northern province of Bengo underwent HIV/AIDS test during prenatal consults at the Maternal and Child Centre of Mabubas, municipality of Dande, in 2011, to learn their HIV status and to avoid complications during birth. [All Africa.com

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Victrelis boceprevir, Ritonavir-Boosted Human Immunodeficiency Virus HIV Protease Inhibitor Drugs - Drug Interaction (AEGiS.org)

clarke — Fri, 10 Feb 2012 13:10:23 +0000

Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs - Drug Interactions (AEGiS.org) - Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs - Drug Interactions
Food and Drug Administration - February 9, 2012 Richard Klein & Kimberly Struble
http://www.aegis.org/news/fda/2012/FD120202.html

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.

Facts about Victrelis (boceprevir) and HIV protease inhibitors

Victrelis is a hepatitis C virus (HCV) protease inhibitor used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults who have not been treated before or who have failed previous treatment.

HIV protease inhibitors are a class of anti-viral drugs used to treat HIV infection.

Ritonavir is an HIV protease inhibitor used to "boost" other HIV protease inhibitors, increasing their levels in the blood and making them more effective.

Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.
Healthcare professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound.
A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with Kaletra (lopinavir/ritonavir) reduced the blood levels of the HIV medicines and boceprevir in the body (see Data Summary below). FDA will be updating the Victrelis drug label to include information about these drug interactions.
Merck and Company has issued a Dear Healthcare Professional letter (PDF - 67KB) with information about this drug interaction study.
Additional Information for Patients

Drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and ritonavir used in combination with other human immunodeficiency virus (HIV) protease inhibitors can potentially reduce the effectiveness of these medicines when they are used together.

Patients should not stop taking any of their medicines without talking to their healthcare professional.

Patients should contact their healthcare professional if they have any questions or concerns about Victrelis or HIV protease inhibitors.

Patients should report side effects from the use of Victrelis or HIV protease inhibitors to the FDA MedWatch program, using the information and links at the bottom of this page.

Additional Information for Healthcare Professionals

Drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and ritonavir-boosted atazanavir, lopinavir, and darunavir can potentially reduce the effectiveness of these medicines when co-administered.

Healthcare professionals who have initiated Victrelis in combination with peginterferon alfa and ribavirin in HIV-HCV co-infected patients on fully suppressive antiretroviral therapy containing a ritonavir-boosted protease inhibitor should discuss these findings with those patients, and closely monitor those patients for HCV treatment response and for potential HCV and HIV virologic rebound.

Victrelis (boceprevir) and Incivek (telaprevir) were approved in May, 2011, each in combination with peginterferon alfa and ribavirin for treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Neither NS3/4A protease inhibitor is approved for treatment of patients co-infected with HIV. Drug interaction data with telaprevir and ritonavir-boosted HIV protease inhibitors can be found in the Incivek drug label (PDF - 314KB). Information about clinical trials in HIV-HCV co-infected patients can be found at ClinicalTrials.gov.

Healthcare professionals should report adverse events involving Victrelis or HIV protease inhibitors to the FDA MedWatch program using the information and links at the bottom of this page.

Data Summary
A pharmacokinetic study evaluated drug interactions between boceprevir (Victrelis) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors in healthy volunteers (n=39). In the study, concomitant administration of Victrelis (boceprevir) with ritonavir (Norvir) in combination with atazanavir (Reyataz), darunavir (Prezista), or with lopinavir/ritonavir (Kaletra) resulted in reduced exposures of the HIV medicines and boceprevir. Victrelis reduced mean trough concentrations of ritonavir-boosted atazanavir, lopinavir, and darunavir by 49, 43 and 59 percent, respectively. Mean reductions of 34 to 44 percent and 25 to 36 percent were observed in area under the curve (AUC) and peak concentration (Cmax) of atazanavir, lopinavir, and darunavir. Co-administration of ritonavir-boosted atazanavir with Victrelis did not alter the exposure (AUC) of boceprevir, but co-administration of Victrelis with lopinavir/ritonavir or ritonavir-boosted darunavir decreased the AUC of boceprevir by 45 and 32 percent, respectively.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-332-0178.

Richard KleinOffice of Special Health IssuesFood and Drug Administration
Kimberly StrubleDivision of Antiviral Drug ProductsFood and Drug Administration120209 FD120202

Physician - HIV - Tri-City Health Center - Fremont, CA

clarke — Fri, 10 Feb 2012 13:05:44 +0000

Physician - HIV - Tri-City Health Center - Fremont, CA - Are you a physician with HIV experience looking for a... looking for a part-time physician that can provide HIV and Primary Care to our patients. This is a three...
From California Primary Care Association - 10 Feb 2012 10:20:01 GMT
- View all Fremont jobs [Indeed.com

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Health Tech (HIV) - Internal Medicine Clinic - Department Of Health And Human Services - Gallup, NM

clarke — Fri, 10 Feb 2012 13:05:20 +0000

Health Tech (HIV) - Internal Medicine Clinic - Department Of Health And Human Services - Gallup, NM - Temporary Health Tech (HIV) position (NTE: 2 years... In relation to HIV: provides patient (individual and group) education; assists with HIV prevention and...
From usajobs.gov - 10 Feb 2012 09:41:44 GMT
- View all Gallup jobs [Indeed.com

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Product Manager - HIV OLP - Gilead Sciences, Inc. - Foster City, CA

clarke — Fri, 10 Feb 2012 13:04:53 +0000

Product Manager - HIV OLP - Gilead Sciences, Inc. - Foster City, CA - Title: Product Manager - HIV OLP Requisition Number... services and external vendors to develop and lead HIV Opinion Leader Programs that support the franchise...
From SanFranJobs.com - 10 Feb 2012 07:26:57 GMT
- View all Foster City jobs [Indeed.com

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Health Tech (HIV) - Internal Medicine Clinic - Indian Health Service - Gallup, NM

clarke — Fri, 10 Feb 2012 13:04:18 +0000

Health Tech (HIV) - Internal Medicine Clinic - Indian Health Service - Gallup, NM - Temporary Health Tech (HIV) position (NTE: 2 years... In relation to HIV: provides patient (individual and group) education; assists with HIV prevention and...
From Indian Health Service - 09 Feb 2012 21:51:09 GMT
- View all Gallup jobs [Indeed.com

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