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The history of AIDS (Acquired Immunodeficiency Syndrome), with timelines, photos, and links to resources on the Internet. Endeavoring to raise public awareness through understanding.
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The History of AIDS: Timeline of the History of HIV/AIDS: 2002 2002 On February 1, 2002, FDA approved a new 600 mg formulation of Sustiva (efavirenz) [PDF] to be taken once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs), for the treatment of HIV infection. On February 5, 2002, FDA approved a new dosing regimen for Agenerase (amprenavir) and Norvir (ritonavir) used in combination. [PDF] In February 2002, Changes in the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT INFORMATION sections of the ZERIT( (stavudine, d4T) label were made to describe the occurrence of lactic acidosis and neuromuscular toxicity in patients using stavudine. On June 26, 2002, a supplemental new drug application from GlaxoSmithKline was approved, expanding the labeled indication to provide for the use of Epivir (lamivudine) once daily for the treatment of HIV infection in combination with other antiretroviral agents, and a new 300 mg tablet. The product label was modified to reflect these changes. Epivir Label FDA announced in July 2002 the analysis of findings from a 2001 study designed to assess the extent and usefulness of private sector prescription information patients receive when filling their prescriptions. Study results show approximately 89 percent of patients received written information about the drugs prescribed for them. In August, 2002 Product labeling changed for AGENERASE (amprenavir) Capsules and AGENERASE (amprenavir) Oral Solution to reflect new precautions related to use of Agenerase with Methadone, and with oral (hormonal) contraceptives. On September 11, 2002, FDA approved the VERSANT HIV-1 RNA 3.0 Assay (bDNA), manufactured by Bayer Corporation of Berkeley, CA. The test is indicated for the direct quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) in plasma of HIV-infected individuals. This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease status as an aid in management of individuals infected with HIV-1. HIV-1 RNA results from the assay can be used to assess prognosis of disease progression and to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of therapy. Monitoring the effects of antiretroviral therapy by serial measurements of plasma HIV-1 RNA has been validated for patients with viral loads ©¯ 25,000 copies/mL. The VERSANT HIV-1 RNA 3.0 Assay (bDNA) is not intended for use as a screening assay for HIV infection or as a diagnostic test to confirm the diagnosis of HIV infection. In September 2002 The VIDEX (Didanosine, ddI) label was revised to include new, precautionary information about co-administration of VIDEX and ribavirin (RBV) in HIV/HCV co-infected patients. In vitro data demonstrating that RBV increases the levels of the active Didanosine metabolite, dideoxyadenosine 5'-triphosphate (ddATP), and clinical reports suggesting the potential for didanosine-related toxicities led to the addition of new precautionary language in the VIDEX label. The following has been added to the "Precautions" section of the label: Exposure to didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) is increased when didanosine is co-administered with ribavirin. Increased exposure may cause or worsen didanosine-related clinical toxicities, including pancreatitis, symptomatic hyperlactatemia/lactic acidosis, and peripheral neuropathy. Co-administration of ribavirin with VIDEX should be undertaken with caution, and patients should be monitored closely for didanosine-related toxicities. VIDEX should be suspended if signs or symptoms of pancreatitis, symptomatic hyperlactatemia, or lactic acidosis develop. On September 25, 2002, FDA Announced that pharmacokinetic data demonstrated that co-administration of VIREAD (tenofovir disoproxil fumarate) and VIDEX (Didanosine, ddI) resulted in significant increases in didanosine exposures; this information was included in the VIREAD label at the time it was initially approved. Subsequent results of an interaction study of VIREAD and VIDEX EC were submitted and reviewed. Based on this later study, it was concluded that the magnitude of the interaction between VIREAD and VIDEX was significant enough to warrant additional precautionary language to be included in both products' labeling. The following precautionary language was added: Exposure to didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) is increased when didanosine is co-administered with VIREAD. Increased exposure may cause or worsen didanosine-related clinical toxicities, including pancreatitis, symptomatic hyperlactatemia/lactic acidosis, and peripheral neuropathy. Co-administration of VIREAD with VIDEX should be undertaken with caution, and patients should be monitored closely for didanosine-related toxicities. VIDEX should be suspended if signs or symptoms of pancreatitis, symptomatic hyperlactatemia, or lactic acidosis develop. On November 7, 2002 FDA approved the first rapid HIV diagnostic test kit for use in the United States that provides results with 99.6 percent accuracy in as little as 20 minutes. Using less than a drop of blood collected, the OraQuick Rapid HIV-1 Antibody Test, manufactured by OraSure Technologies, Inc., Bethlehem, Pennsylvania, can quickly and reliably detect antibodies to HIV-1, the HIV virus that causes infection in most cases in the U.S. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional laboratory or clinical settings. Although the results of rapid screenings are reported in point-of-care settings, as with all screening tests for HIV, if the OraQuick test gives a reactive test result, that result must be confirmed with an additional specific test. The OraQuick test has not been approved to screen blood donors. In November 2002 FDA issued new guidance on clinical trial design in developing treatment for HIV infection [PDF]. The guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the Agency's current thinking regarding designs of clinical trials that use HIV ribonucleic acid (RNA) measurements to support accelerated and traditional approvals of antiretroviral drug products. It is also intended to serve as a focus for continued discussions among the Division of Antiviral Drug Products (DAVDP), pharmaceutical sponsors, the academic community, and the public. On December 31, 2002, FDA approved a new, extended release formulation of ZERIT® (stavudine, d4T) called ZERIT® XR, a product of the Bristol-Myers Squibb Company. This extended-release formulation has been demonstrated to maintain measurable plasma concentrations for 24 hours after once-daily dosing. ZERIT® XR is indicated for the treatment of HIV in combination with other antiretrovirals. The recommended dose of ZERIT® XR is 100 mg once daily for individuals weighing at least 60 kg and 75 mg once daily for individuals weighing less than 60 kg. 2000 ...Last ||| Next... 2003 |