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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: 2004 2004 On January 12, 2004 FDA approved a labeling supplement for Crixivan (Indinavir Sulfate) Capsules summarizing tubulointerstitial nephritis with medullary calcification and cortical atrophy observed in patients with asymptomatic severe leukocyturia (>100 cells/high power field) and reports of Immune reconstitution syndrome in patients treated with combination antiretroviral therapy (CART), including CRIXIVAN. During the initial phase of treatment, patients responding to antiretroviral therapy whose immune system responds to CART may develop an inflammatory response to indolent or residual opportunistic infections (such as MAI, CMV, PCP, or TB), which may necessitate further evaluation and treatment." Additionally, information was added about Reyataz (atazanavir): "Both CRIXIVAN and atazanavir are associated with indirect (unconjugated) hyperbilirubinemia. Combinations of these drugs have not been studied and coadministration of CRIXIVAN and atazanavir is not recommended." Changes were also made to the Patient Package Insert (PPI) indicating that "In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from opportunistic infections may occur when combination antiretroviral treatment is started. In March 2004, new drug interaction information led to changes in the REYATAZ (atazanavir sulfate) label based on drug-drug interactions. Tenofovir decreases the AUC (area under the curve) and Cmin (minimum concentration) of REYATAZ. When coadministered with tenofovir, it is recommended that REYATAZ 300 mg is given with ritonavir 100 mg and tenofovir 300 mg (all as a single daily dose with food). REYATAZ without ritonavir should not be coadministered with tenofovir. In March, 2004, FDA has approved new dosing recommendations for VIRACEPT (nelfinavir) in patients 2 years of age or older, based on clinical and pharmacokinetic data from 5 pediatric studies. On March 19, 2004, FDA approved the OraSure rapid test for detection of HIV-2 when used with a whole blood sample. The rapid test kit is identical to the earlier approved version, however, subsequent data submitted to the agency has demonstrated its ability to detect HIV-2. On March 26, 2004, FDA approved the use of oral fluid samples with a rapid HIV diagnostic test kit that correctly identified 99.3 of specimens from infected people (sensitivity) and 99.8% of specimens from uninfected people (specificity) in limited studies provided by the manufacturer in support of this approval. The test provides the result in approximately 20 minutes. On March 26, 2004, the OraQuick Rapid HIV-1 Antibody Test was approved for testing plasma for HIV-1 and HIV-2 (a variant of HIV that is prevalent in parts of Africa but rarely found in the United States). In May, 2004, FDA approved changes in the label for Voriconazole (VFEND) triazole antifungal agent to include drug interaction information when coadministered with efavirenz or ritonavir. In May, 2004, revisions were made to the Crixivan product label to reflect data about drug-drug intereactions, including those related to VIAGRA (sildenafil), CIALIS (tadalafil), or LEVITRA (vardenafil), and REYATAZ (atazanavir). On May 17, 2004, FDA issued a guidance document that describes a process to expedite approval of low cost, safe and effective co-packaged and fixed dose combination (FDC) HIV therapies so that high quality drugs can be made available in Africa and developing countries around the world under the President's Emergency Plan for AIDS Relief. On May 20, 2004, FDA published a new Final Rule on Donor Eligibility for Human Tissues and Cells (Eligibility Determination for Donors of human Cells, Tissues, and Cellular and Tissue-Based Products), and draft guidance (Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products) related to donor screening and eligibility. These documents include HIV, among a variety of conditions for which cell and tissue donor screening would be required. Federal Register Notice (PDF 363 MB); Draft Guidance Document (PDF 143 MB); Questions and Answers In May, 2004, FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the product labeling for DESYREL (trazodone hydrochloride) Tablets, indicated for the treatment of depression, citing a potential for drug interactions when trazodone is given with the CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir. Dear Health Care Provider Letter On June 25, 2004, FDA granted a CLIA (Clinical Laboratory Improvements Amendments of 1988] waiver to the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid, a fast and non-invasive test approved on March 26, 2004, to detect antibodies to HIV-1 in oral fluid. The oral fluid indication was extended by FDA to include detection of antibodies to HIV-2 in oral fluid on June 22, 2004. The CLIA waiver allows the rapid oral fluid test to be used in more health care settings, such as doctors' offices, clinics, and some mobile labs that can offer testing in high-risk areas. Through these venues, testing are accessible to many more people, particularly to those individuals who are reluctant to be tested due to the need to draw blood. On July 1, 2004, the VIREAD (tenofovir disoproxil fumerate) label was updated to recommend against use in patients with chronic hepatitis B infection, because of severe, acute exacernations of Heptatitis B may occur in patients who are coinfected with hepatitis B and HIV and have discontinued Viread. On July 6, 2004, FDA approved a new dosing regimen for REYATAZ of 300 mg (two 150 mg capsules) once daily plus ritonavir 100 mg once daily taken taken with food in antiretroviral-experienced patients. For antiretroviral-naïve patients the recommended dose remains as REYATAZ 400 mg (two 200 mg capsules) once daily with food. On July 27, 2004, FDA launched a new web page to consolidate records of advisory committee meetings related to HIV/AIDS and associated conditions, making them easier to access. The new page, which lists HIV/AIDS-related advisory committee meetings held since 1996, indexed by topic and by year. It is the first consolidation of advisory committee records by topic, and includes records of meeting held by advisory committees related to drugs, biologics, and medical devices, with links to a variety of documents, such as meeting announcements, committee rosters, briefing materials - which often contain background materials and slides - and meeting transcripts. Topics include consideration of new drug applications, regulatory policy issues, and trial design topics. FDA Advisory Committees Page. On August 2, 2004, FDA approved two fixed-dose combination (FDC) antiretroviral drug products for use with other antiretroviral agents for the treatment of HIV-1 infection. The FDCs are GlaxoSmithKline's EPZICOM (abacavir/lamivudine) and Gilead Sciences, Inc.'s TRUVADA (tenofovir disoproxil/emtricitabine). These FDC approvals are important because they provide simplified dosing regimens - one pill, once daily, for the component of multi-drug therapy represented by these FDCs. On August 3, 2004, FDA approved Sculptra to correct facial fat loss in people with human immunodeficiency virus (HIV). Sculptra, a medical device, is a product of Dermik Laboratories, of Berwyn, PA. It is an injectable form of poly-L-lactic acid, a biodegradable, biocompatible synthetic polymer from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches, bone screws and facial implants. It is the first such treatment approved for the condition known as lipoatrophy, or facial wasting. FDA expedited review of the product because of its importance in treating people living with AIDS. In August 2004, Sustiva labeling was revised to include safety and efficacy data representing 168 weeks of treatment from Study 006 ( efavirenz + lamivudine + zidovudine vs indinavir + lamivudine + zidovudine vs efavirenz + indinavir) and other available data. On September 23, 2004, FDA held a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to update the Committee on the phase 3 Thai trial of ALVAC vCP 1521 [Aventis Pasteur, Inc.] with AIDSVAX B/E [VaxGen, Inc.] (HIV-1 Recombinant Canarypox-Vectored Vaccine with Recombinant gp 120 B/E) for the prevention of HIV-1 infection. On October 7, 2004, FDA held a public workshop entitled "From Concept to Consumer: Center for Biologics Evaluation and Research (CBER) Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies" to provide stakeholders a forum for the development of innovative scientific knowledge and tools to facilitate the development and availability of new biological products including vaccines, blood and blood products, and cellular, tissue, and gene therapies. In October 2004, Kaletra (lopinavir and ritonavir) Soft Gel Capsules and Oral Solution labeling was revised to include long-term (week 144-204) efficacy and safety results from two phase II trials. These were the Week 204 efficacy results from study M97-720 in antiretroviral-naïve subjects and the Week 144 results from study M97-765 in antiretroviral-experienced subjects were included in the label. In addition, results of a multiple dose study in HIV and HCV co-infected subjects with mild to moderate hepatic impairment and Week 104 mice and rat data were submitted to update the respective sections of the package insert. On October 15, 2004, FDA granted" traditional approval" for Fuzeon (enfuvirtide, also known as T-20) injection, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment experienced patients with ongoing viremia. FDA originally approved Fuzeon on March 13, 2003 under the regulations at 21 CFR 314, Subpart H, for accelerated approval of new drugs for serious or life-threatening illnesses. On November 12, 2004 Bristol-Myers Squibb (BMS) issued a "Dear Healthcare Provider" letter regarding is important new clinical data regarding coadministration of Viread (tenofovir disoproxil fumarate [TDF]), Videx EC (didanosine delayed-release capsules enteric-coated beadlets [ddI EC]), and either Sustiva (efavirenz [EFV]) or Viramune (nevirapine [NVP]). In November, 2004, FDA issued final guidance on the "Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV." On November 26, 2004 FDA issued draft guidance for industry entitled "Role of HIV Drug Resistance Testing in antiretroviral Drug Development," addressesing the role of HIV resistance testing during antiretroviral drug development and postmarketing. The draft guidance discusses the nonclinical studies (mechanism of action; antiviral activity in vitro; cytotoxicity/therapeutic index; and the effects of serum protein binding on antiviral activity) recommended be completed prior to the initiation of phase 1 clinical studies in HIV-infected patients, as well as the use of resistance testing in the clinical phases of drug development and recommends the type of information that should be collected, and the types of analyses that should be conducted to characterize an antiretroviral's resistance profile. It also reviewes the role of resistance testing in initial activity and dose-finding, for study enrollment criteria, for background regimen selection, and to establish an indication. On December 3, 2004, FDA approved a generic formulation of Didanosine (ddI) Delayed Release capsules, 200 mg, 250 mg, and 400 mg for use in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults. The product, manufactured by Barr Laboratories, Inc. of Pomona, NY, is the first approval in the United States of a generic antiretroviral therapeutic formulation to treat HIV/AIDS. On December 17, 2004, FDA approved a new 500 mg tablet formulation of the HIV protease inhibitor, INVIRASE (saquinavir mesylate). The dosage and administration for INVIRASE in adults (over the age of 16 years) is 1000 mg twice a day (taken as either two 500 mg tablets or five 200 mg capsules) in combination with ritonavir 100 mg twice a day, after a meal. The new tablet formulation reduces the pill burden compared to the capsule formulation. On December 30, 2004, FDA approved the Multispot HIV-1/HIV-2 Rapid Test. This device, manufactured by Bio-Rad Laboratories, Redmond, WA, is indicated for the detection and differentiation of circulating antibodies associated with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. 2003 ...Last ||| Homepage |