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[ by | Jan 6, 2012 10:23 am | Comments Off ]

Generic Version Of Combivir Is Now Available – The generic version of Combivir (lamivudine/zidovudine), made by generic drug maker Teva Pharmaceuticals, is now available. Teva stated that it began shipping its generic form to pharmacies starting December 27. Generic Combivir was approved by the U.S. Food and Drug Administration (FDA) in May 2011 (see related AIDS Beacon news). For more information, please see the article in Businessweek or the Teva Pharmaceuticals website.

Truvada For Prevention Of HIV Makes Time Magazine’s “Top 10 Medical Breakthroughs” For 2011 – Results from several studies showing that a daily dose of the antiretroviral Truvada (emtricitabine/tenofovir) can reduce the risk of HIV infection by 60 percent to 90 percent were declared one of the top 10 medical breakthroughs of 2011 by Time Magazine. The magazine noted that if the antiretrovirals were made widely available they could help curb the HIV/AIDS epidemic. The primary study, HPTN 052, was also chosen by Science Magazine as “2011 Breakthrough of the Year.” Gilead Sciences, which makes Truvada, applied for FDA approval to market the drug as an HIV prevention measure in December (see related AIDS Beacon news). However, Bloomberg noted that the drug costs $12,000 per year and has side effects, both of which may prevent widespread implementation. For more information, please see the articles in Time Magazine, Science Magazine, and Bloomberg.

Physicians Caution That Certain Anti-Seizure Drugs May Interfere With Antiretrovirals – New guidelines from American Academy of Neurology warn that certain anti-seizure medications, such as those taken to treat epilepsy, may interact with antiretroviral medications for HIV/AIDS. For example, the guidelines note that valproic acid (Depakote, Depakene) may increase the concentration of zidovudine (Retrovir) in the blood, increasing the risk of toxicity and side effects. Several anti-seizure medications also may interact with Norvir (ritonavir)-boosted Reyataz (atazanavir) and Kaletra (lopinavir/ritonavir). The guidelines recommend that people with HIV and seizure disorders share with their clinician what medications they are taking so that drug types and dosages can be adjusted if needed. For more information, please see the guidelines (pdf) or the patient information guide (pdf) at the American Academy of Neurology website.

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[ by | Dec 27, 2011 1:11 pm | Comments Off ]

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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[ by | Dec 19, 2011 11:30 am | Comments Off ]

Gilead Applies For Approval For Truvada As An HIV-Prevention Drug – Gilead Sciences has applied for approval from the U.S. Food and Drug Administration (FDA) to market Truvada (emtricitabine/tenofovir) for the prevention of HIV infection. The application is based on studies showing that taking Truvada once a day helped reduce the rate of new HIV infections in high-risk populations, such as men who have sex with men, by about 70 to 90 percent when taken regularly (see related AIDS Beacon news). If approved, Gilead stated that Truvada would be the first drug approved for the prevention of HIV infection via sexual transmission in uninfected adults. For more information, please see the Gilead Sciences press release.

People With HIV May Be At Higher Risk Of Migraines – Results from a recent study indicate that people with HIV may be at a higher risk of headaches, particularly migraines, than people without HIV. The researchers found that more than half of study participants reported headaches; more than 85 percent of these patients met the criteria for migraine headaches. According to the scientists, this represents a 13-fold higher risk of chronic migraines in people with HIV compared to the general population. The researchers also found that more advanced HIV infection was associated with more severe headaches. For more information, please see the press release from the University of Mississippi or the study in the journal Headache (abstract).

2012 Federal Spending Bill Bans Needle Exchange Programs For HIV Prevention – The 2012 federal spending bill, approved by Congress last week, contains a provision that prohibits federal money from being used for needle exchange programs for illegal drug users. The programs are meant to help prevent transmission of HIV and other blood-borne diseases by ensuring that users do not share needles. The AIDS Institute, a non-profit AIDS advocacy organization, expressed disappointment with the bill and also noted that funds remained flat for programs such as the Ryan White Program, which provides money to care for low-income people with HIV. For more information, please see the article in the Washington Post or the press release from The AIDS Institute.

Florida “Faces Of HIV” Project To Launch In Tallahassee, FL – Florida state will launch its traveling “Faces of HIV” exhibit January 13 at Florida State University in Tallahassee, FL. The project showcases the faces, experiences, and daily lives of people with HIV. The aim of the exhibit is to reduce stigma against people with HIV and to demonstrate that HIV infection strikes all sexes, ages, and races and cannot be deduced from a person’s appearance. The project will also stop in Orlando, Miami, Tampa, and Jacksonville, FL. For more information, please see the Faces of HIV website at the Florida Department of Health.

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[ by | Dec 13, 2011 1:47 pm | Comments Off ]

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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[ by | Dec 5, 2011 11:11 am | Comments Off ]

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.