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ATC for Salvage Therapy

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ATC for Salvage Therapy
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February 23, 2013 To: The Honorable Alcee Hastings 2353 Rayburn House Office Building United States House of Representatives Washington, DC 20515 The Honorable Maxine Waters 2221 Rayburn House Office Building Washington, DC 20515-0535 Dear Congressman Hastings and Congresswomen Waters, We are writing to ask for your support in obtaining federal facilitation for the final Phase III HIV/AIDS clinical trial of apricitabine (ATC), a phase III nucleoside reverse transcriptase inhibitor (NRTI), that will inevitably lead to FDA-approval of ATC and provide NRTI-resistant HIV/AIDS patients, as well as patients suffering potentially life-threatening toxicities from currently available NNRTIs, with a much needed salvage therapy treatment option. NRTIs are a vital component of effective HIV treatment, and are recommended by expert panels in both the U.S. and Europe. Treatment regimens that do not include 2 NRTIs are less durable, less robust, and more prone to fail. NRTIs are utilized as the “backbone” of treatment regimens by a majority of clinicians and are essential to constructing an effective and durable HIV treatment regimen. Yet there are precious few new NRTIs being developed to replace older NRTIs when they fail. While FDA approval of Gilead’s Stribild (“the Quad Pill”) was highly anticipated by HIV/AIDS patients, clinicians, advocates and policy makers, there remains an urgent need for federal facilitation to develop new NRTIs to fulfill the needs of NRTI-resistant HIV/AIDS patients and HIV/AIDS patients suffering NRTI potentially life-threatening and irreversible toxicities, including those resistant to the 2 NRTIs contained in Truvada (TVD; tenofovir[TDF]/ emtricitabine[FTC]) and those experiencing severe TDF-related toxicities, as TDF is the potentially harmful component of Atripla, Complera, and Stribild, the only three one-pill, once-a-day treatments. TDF/FTC is ineffective for many drug resistant, treatment-experienced patients, and as many as 21-77% of this nation’s 750,000-800,000 HIV/AIDS patients taking these TDF-containing products are suffering kidney, i.e. kidney failure that can result in costly hospitalizations and kidney transplants and/or death, and/or bone toxicities, i.e. osteoporosis that can result in bone fractures, costly prolonged hospitalizations and rehabilitation, and, in many cases, death. TVD is the main NRTI backbone recommended internationally, but the extensive use of TVD-containing drug regimens to treat HIV/AIDS patients both in the U.S. and PEPFAR partner countries, means patients who fail these regimens often have difficulty finding a new NRTI backbone because of drug resistance and mutations and/or these toxicities. We currently have available only 2 NRTI backbone options from which we individualize and construct our patients’ HIV regimens. Recent findings show that only 28% of HIV/AIDS patients in the U.S. are able to achieve durable viral suppression which has been proven to prevent HIV transmission up to 96% of the time from HIV-positive patients who have sex with HIV-negative partners. Being that Atripla, Complera, and Stribild contain TDF/FTC as their NRTI backbone, patients who are resistant to TDF/FTC are technically also resistant to and unable to take Atripla, Complera or Stribild, the three once-daily, one pill, fixed dose combinations (FDCs). Two additional FDCs containing TDF/FTC should be FDA-approved within the next 12-18 months, and these FDCs will not be an option for those HIV/AIDS patients resistant to or already harmed by TDF/FTC! In short, the treatment options available for drug-resistant, treatment-experienced patients and/or patients experiencing serious drug-related toxicities from TDF/FTC are increasingly limited. Furthermore, with the FDA approval of Truvada for pre-exposure prophylaxis (PrEP), HIV-negative people taking Truvada who subsequently become HIV-infected are also at risk of developing drug resistance and serious bone marrow and kidney toxicities, which eliminates all three of the available FDCs as future treatment options. In other words, we desperately need new NRTIs! There is an urgent need for the development of new and safer NRTIs that are effective against drug-resistant NRTIs, are not subject to cross-class resistance, and can be used safely and effectively in combination with other available HIV medications. The most promising NRTI in clinical development for treatment-experienced patients and closest to regulatory approval is ATC, which is in Phase III development by Avexa. ATC has been found to be effective in patients who are resistant to Truvada and have the most common, detrimental mutations causing NRTI and cross-resistance. ATC shows no resistance development or cross-resistance with other NRTIs, is very well tolerated, and can be used in combination with other currently available ARVs. It has a very good safety profile and shows no evidence of mitochondrial, bone marrow, pancreatic, kidney or liver toxicities. In summary, we are asking for your support because the FDA has agreed to a final Phase IIII registrational trial of 300 patients with limited treatment options due to drug resistance and/or tolerability. Federal facilitation for the completion of the clinical development of ATC and the advancement of other new NRTIs in clinical development for drug resistant, treatment-experienced patients must be prioritized to maintain and further the successes in controlling the HIV/AIDS crisis. Respectfully, Gary Blick, MD, AAHIVS President, World Health Clinicians, Inc. Medical Director, CIRCLE CARE Center 618 West Avenue Norwalk, CT 06850 T: 203-852-9525; F: 203-854-0371 Email: blickmd@whcccc.org www.worldhealthclinicians.org Jeannie Wraight Editor-in-Chief HIV Haven 347-758-8693 jeannie.wraight@yahoo.com www.hivhaven.com On behalf of the Undersigned:

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