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Gilead Sciences announced yesterday that the U.S. Food and Drug Administration (FDA) has approved Viread for children two to 12 years of age, for use in combination with other antiretrovirals.

“We are very pleased to provide an important new therapeutic option for younger HIV patients, and will work to make the pediatric formulations of Viread available as quickly as possible,” said Norbert Bischofberger, executive vice president of Research and Development and chief scientific officer of Gilead Sciences, in a press release.

Viread will be available as tablets in smaller doses…

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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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The U.S. Food and Drug Administration (FDA) announced yesterday that it has approved Isentress for children two to 18 years of age who weigh at least 22 pounds (10 kilograms).

“Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release.

Isentress will be available as a chewable 100 mg scored tablet and a chewable 25 mg…

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The U.S. Food and Drug Administration (FDA) has approved a new, liquid formulation of Prezista.  The new formulation will be available for children aged three to six years old as well as children or adults who cannot swallow Prezista pills.

Previously, Prezista was only approved for children six years old or older and came only in a tablet form. Prezista is still not approved for children under three years old due to possible toxicity in children this young.

The new liquid form of Prezista will come as a 100 mg/ml…

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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…