Articles tagged with: Quad
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HHS Warns Against Three-Month Short-Course Tuberculosis Treatment For People On Antiretroviral Therapy – The Department of Health and Human Services (HHS) has warned that people with HIV who are on antiretroviral therapy should not take the new shortened, three-month regimen of weekly isoniazid plus Priftin (rifapentine) for treatment of latent tuberculosis. Priftin may reduce the efficacy of antiretrovirals, so HHS recommends that people on antiretroviral therapy instead receive the traditional nine-month treatment course of daily isoniazid. People with HIV who are at least 12 years old and are not on antiretroviral therapy can choose to take the three-month treatment course, as can certain patients under the age of 12 on a case-by-case basis. However, HHS stated that the shorter regimen should not be used in patients under two years of age. HHS also noted that efficacy of the shorter regimen has not yet been established in people with HIV. For more information, please see the HHS Information Sheet (pdf).
FDA Accepts Gilead’s Application For Approval Of “Quad” Combination Antiretroviral – The U.S. Food and Drug Administration (FDA) has accepted Gilead Science’s application for approval of its investigational “Quad” combination antiretroviral pill. The Quad regimen is a fixed-dose, single tablet consisting of the investigational booster drug cobicistat, the investigational integrase inhibitor elvitegravir, and Truvada (emtricitabine/tenofovir). Gilead submitted its application to the FDA in October; the FDA has stated that it will make a decision on the drug by August 27, 2012. For more information, please see the Gilead Sciences press release.
Gilead Files For Approval Of “Quad” Combination Antiretroviral In Europe – Gilead Sciences has also applied for marketing approval of its investigational “Quad” combination antiretroviral pill from the European Medicines Agency (EMA). If approved, the Quad will be the third all-in-one combination antiretroviral pill approved in Europe; the first two, also marketed by Gilead Sciences, were Atripla (efavirenz/emtricitabine/tenofovir) and Eviplera (rilpivirine/emtricitabine/tenofovir), known as Complera in the U.S. Based on average approval times for the EMA, a decision would be expected mid to late next year. For more information, please see the Gilead Sciences press release.
Merck Agrees To Cut Price Of Isentress For ADAPs – U.S. pharmaceutical company Merck has agreed to lower its price for Isentress (raltegravir) for state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. The agreement follows pledges by Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) to also reduce the prices they charge ADAPs for their HIV drugs (see related AIDS Beacon news). Due to state budget crises and an increase in the number of people requesting assistance, many states have tightened eligibility requirements or implemented waiting lists for ADAPs. For more information, please see the Merck press release.
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Updated results from a 96-week Phase 3 clinical trial continue to indicate that the investigational integrase inhibitor elvitegravir is as effective and safe as Isentress in previously treated people with HIV.
“These positive two-year data indicate that elvitegravir has the potential to be an important new once-daily treatment option for people living with HIV who have developed resistance to other therapies,” said Norbert Bischofberger, executive vice president of Research and Development and chief scientific officer of Gilead Sciences, which is developing elvitegravir, in a press release.
“In addition, we are…
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Los resultados de un estudio clínico en fase 3 aún en curso indican que la pastilla de combinación conocida informalmente como “Quad”, que se toma una vez al día, es tan eficaz como el Reyataz combinado con la Truvada en las personas con VIH que no han recibido tratamiento previo.
Basándose en los resultados, el Dr. Norbert Bischofberger, vicepresidente ejecutivo de Investigación y Desarrollo y director científico de Gilead Sciences, declaró en un comunicado de prensa que Gilead comenzará a trabajar en la aprobación de la pastilla “Quad” a finales…
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Gilead Sciences announced yesterday that it has submitted its investigational once-daily combination “Quad” pill for approval from the United States Food and Drug Administration.
The Quad regimen is a fixed-dose, single tablet consisting of the investigational booster drug cobicistat, the investigational integrase inhibitor elvitegravir, and Truvada (emtricitabine/tenofovir).
According to a representative from Gilead, the company is seeking approval only for previously untreated HIV-positive adults at this time.
The submission is based on results from two Phase 3 studies showing that the Quad…
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Results of an ongoing Phase 3 clinical trial indicate that the once-daily, combination pill known informally as the “Quad” pill is as effective as Reyataz plus Truvada in people with previously untreated HIV.
Based on the results, Dr. Norbert Bischofberger, executive vice president of Research and Development and chief scientific officer of Gilead Sciences, said in a press release that Gilead would begin working toward approval of the Quad pill by the end of the year, rather than early next year as previously stated.
“The 90 percent response rate observed…