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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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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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Isentress Prescribing Information Updated To Warn Of Severe Rash – The U.S. Food and Drug Administration (FDA) recently announced that the prescribing information for Isentress (raltegravir) has been updated to include a warning about the risk of a severe, potentially life-threatening rash. According to the FDA, patients taking Isentress should immediately contact their physician if they develop a rash. Physicians should advise patients to immediately stop taking Isentress if they develop a rash and have one or more of the following symptoms: fever, a general feeling of illness, extreme tiredness, muscle or joint aches, blisters, mouth lesions, eye inflammation, facial swelling or swelling of the eyes, lips, or mouth, breathing difficulties, or signs of liver problems (such as yellowing of the skin or eyes or pain under the ribs). For more information, please see the FDA press release.

AIDS Patients Sue Ohio Department Of Health Over New ADAP Regulations – Three HIV-positive patients and advocates have sued the Ohio Department of Health over new restrictions to the state’s AIDS Drug Assistance Program (ADAP), which provides free antiretrovirals to low-income people with HIV. According to the lawsuit, Department of Health officials failed to follow state laws on adopting new regulations, making them illegal. The plaintiffs also argue that the regulations would arbitrarily deny treatment to people with HIV. The new regulations would allow the Department to tighten restrictions on patient income for ADAP eligibility; they also include medical guidelines to determine waitlist priority if a waitlist is needed. A judge granted an injunction last week delaying implementation of the new regulations until the lawsuit has been resolved. For more information, please see the article on the New England Cable News website or the AIDS Healthcare Foundation press release.

Vertex Pharmaceuticals To Initiate Phase 3 Trial Of 12-Week Hepatitis C Regimen – Vertex Pharmaceuticals, the developer of Incivek (telaprevir), announced last week that it will initiate a Phase 3 trial of a 12-week hepatitis C treatment regimen consisting of Incivek, peginterferon-alfa, ribavirin, and its investigational hepatitis C virus polymerase inhibitor VX-222. The trial will test the regimen in both previously untreated and relapsed hepatitis C patients. The announcement of the new trial is based on results from a Phase 2 clinical trial that showed that 93 percent of patients treated with the four-drug regimen were cured of hepatitis C after 12 weeks. For more information, please see the Vertex Pharmaceuticals press release.

Bristol-Myers Squibb Investigates 12-Week, Interferon-Free Hepatitis C Treatment Regimen – Bristol-Myers Squibb is also independently investigating a 12-week, interferon-free treatment regimen for the treatment of hepatitis C. Bristol-Myers Squibb announced that it is adding the new 12-week treatment protocol to an existing Phase 2 clinical trial that is testing the same regimen as a 24-week treatment program. Patients will receive the investigational polymerase inhibitor PSI-7977 (developed by Pharmasett) plus Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor daclatasvir (BMS-790052). Some patients will also receive ribavirin. The trial will test the regimens in both previously untreated patients and patients who have failed treatment with Incivek or Victrelis. For more information, please see the Bristol-Myers Squibb press release.

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Interim results from a Phase 3 clinical trial show that the investigational integrase inhibitor elvitegravir, taken once daily, may be as effective and safe as twice-daily Isentress in treatment-experienced HIV-positive adults.

“[Patients] could use elvitegravir [once daily] instead of Isentress [twice daily] in combination with a boosted protease inhibitor with the same efficacy and safety,” said Dr. Jean-Michel Molina, a researcher at the Hôpital Saint Louis and University of Paris and lead author of the study.

The study authors noted that once daily dosing as opposed to twice daily dosing…