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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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Norvir Prescribing Information Updated To Include Risk Of Life-Threatening Skin Condition – The U.S. Food and Drug Administration (FDA) has approved updated prescribing information for Norvir (ritonavir) to warn of the possibility of toxic epidermal necrolysis, a rare, life-threatening reaction to medications in which the top layer of skin detaches from the bottom layer and dies. The new prescribing information also notes that when Norvir is taken with the cancer drugs Tasigna (nilotinib) or Sprycel (dasatinib), used to treat certain forms of leukemia, or the painkiller fentanyl (Duragesic, Actiq), dose adjustments of these drugs may be necessary. For more information, please see the FDA press release.

Gilead Sciences And Janssen Therapeutics Agree To Lower AIDS Drug Prices For ADAPs – Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) have reached agreements with the ADAP Crisis Task Force (ACTF) to further reduce the prices for antiretrovirals purchased by state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. 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. According to ACTF, there were 6,595 people on ADAP waiting lists nationwide as of November 17. For more information, please see the press releases from ACTF (pdf) and the AIDS Healthcare Foundation.

GeoVax Begins Phase 1/2 Trial Of Therapeutic AIDS Vaccine; Still Recruiting Participants – Biotechnology company GeoVax Labs announced today that the first patient has received a dose of its investigational therapeutic HIV vaccine as part of a Phase 1/2 trial. The company is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. The company also noted that it is still recruiting participants for the trial. Eligible participants must be HIV-positive and have started antiretrovirals within 18 months of their last negative HIV test; or have had a negative HIV test within the past 18 months and not yet started antiretrovirals. For more information, please see the GeoVax press release (pdf) or the U.S. Clinical Trials Registry.

Governors Push For Legalization Of Medical Marijuana – The governors of Rhode Island and Washington states have petitioned the federal government to legalize use of marijuana for medicinal purposes. Both states have legalized medical marijuana, and the governors argue that the change in federal law is necessary so that state employees are not prosecuted for distributing the drug. The U.S. Justice Department had previously sent letters to state governments warning of prosecution if they continued to distribute medical marijuana (see related AIDS Beacon news). The federal Drug Enforcement Agency rejected a request to reclassify the drug as acceptable for medicinal use in June; however, the governors argued that the evidence used for that rejection is several years old and that the medical community has since changed its stance on marijuana. For more information, please see the article in the New York Times.

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President Obama Allocates An Additional $35 Million Toward ADAPs – In a speech on December 1, World AIDS Day, President Obama announced that the federal government will contribute an additional $35 million to state AIDS Drug Assistance Programs (ADAPs). The programs, which provide free antiretrovirals to low-income people with HIV, have faced budget shortfalls due to the economic crisis, forcing many states to tighten eligibility requirements and implement waiting lists. President Obama also allocated an additional $15 million toward HIV clinics and treatment centers. According to government officials, the funds represent a reallocation of existing Department of Health and Human Services funds rather than additional money. For more information, please see the Associated Press article.

Phase 3 Trial Results Show Gilead’s Investigational Booster Cobicistat Is Effective And Safe – Interim 48-week results from an ongoing Phase 3 clinical trial show that Gilead Science’s investigational boosting agent cobicistat is as effective as Norvir (ritonavir). Boosting agents are drugs that allow patients to take medications less often without losing efficacy. Results showed that 85 percent of previously untreated adults with HIV who took cobicistat-boosted Reyataz (atazanavir) plus Truvada (emtricitabine/tenofovir) successfully achieved undetectable viral loads (amount of HIV in the blood), compared to 87 percent of study participants taking Norvir-boosted Reyataz plus Truvada. Discontinuation rates due to side effects were similar between the two groups of participants. Based on the results, Gilead stated that it would apply for approval of cobicistat from the U.S. Food and Drug Administration in the second quarter of 2012. For more information, please see the Gilead Sciences press release.

Supreme Court To Decide On Government Liability For Breaches Of HIV Privacy – Justices for the U.S. Supreme Court will hear arguments this week on whether the federal government can be held liable for emotional distress when it illegally discloses a person’s HIV status. The government was sued by an HIV-positive pilot whose status was disclosed to officials at the Federal Aviation Administration by officials in the Social Security Administration, violating medical privacy laws. The government argues that it is only responsible for damages due to economic losses from such violations, not emotional distress. For more information, please see the article in the Los Angeles Times.

Merck Initiates Anti-Stigma Initiative For People With HIV And Their Clinicians – U.S. pharmaceutical company Merck has announced a new anti-stigma initiative to improve health care and communication between people with HIV and their clinicians. The program, called Clinic Activation to Lead and Implement Best Practices for Enhancing Response to HIV (CALIBER), includes a website with a discussion guide on dealing with and reducing stigma related to HIV and an expert panel of physicians to help answer stigma-related questions. For more information, please see the Merck press release (pdf) or the CALIBER website.

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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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Rate Of New HIV Infections In The U.S. Is Stable – A report issued by the U.S. Centers for Disease Control and Prevention (CDC) last week indicates that the annual rate of new HIV infections has stabilized at about 50,000 new infections per year in the U.S. However, the CDC also found that the rate of new infections rose 48 percent between 2006 and 2009 in young African-American men who have sex with men. Rates for all other race and risk groups remained stable. The CDC noted that most new infections (61 percent) are still among men who have sex with men, although 11 percent of new infections in 2009 were in African-American women, who are now 15 times more likely to contract HIV than Caucasian women. For more information, please see the CDC press release or the report in PLoS One.

Federal Government Reverses Limits On Emergency Funding To State ADAPs – The federal Health Resources and Services Administration (HRSA) has reversed a previous decision to limit emergency funding to AIDS Drug Assistance Programs (ADAPs) to $3 million per state. Instead, states will be allowed to receive at least as much emergency assistance as they received last year. In July, Congress authorized $50 million in emergency funding for ADAPs, which provide free antiretrovirals to low-income people with HIV. Several state ADAPs have faced budget crises, and 13 states currently have waiting lists. Activists protested HRSA’s initial decision to limit the emergency funds to a maximum of $3 million per state, which is less than some states, such as Florida, received last year in emergency funds. For more information, please see the article in The Florida Independent.

Bristol-Myers Squibb Recruits Participants For Phase 2 Clinical Trial Of New Antiretroviral – Bristol-Myers Squibb (BMS) is currently recruiting participants for a Phase 2 clinical trial of its investigational antiretroviral BMS-663068. BMS-663068 is a new type of antiretroviral that prevents HIV from entering and infecting cells. The trial will test the new drug at four different dosages, including both once-daily and twice-daily dosages, in combination with Isentress (raltegravir) and Viread (tenofovir). Eligible participants must have been treated for HIV previously but cannot have taken Isentress. Participants must also have viral loads (amount of HIV in the blood) of 1,000 copies per milliliter or higher. BMS expects to recruit approximately 250 participants. For more information, please see the U.S. Clinical Trials Registry.