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[ by | Feb 10, 2012 9:15 am | Comments Off ]
FDA Warns That Victrelis May Reduce Efficacy Of Norvir-Boosted Protease Inhibitors

The United States Food and Drug Administration (FDA) warned yesterday that the hepatitis C drug Victrelis has been found to reduce the efficacy of several Norvir-boosted protease inhibitors.

In particular, Victrelis reduces the blood concentrations of Norvir-boosted Reyataz, Prezista, and Kaletra.

The FDA stated that patients should not stop taking Victrelis or their antiretrovirals if they have been prescribed. However, patients should be closely monitored for antiretroviral treatment failure or hepatitis C treatment failure.

The FDA also encouraged patients to report any side effects they experience while taking Victrelis or …

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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 | Jul 18, 2011 12:13 pm | Comments Off ]

Abbott Laboratories To Develop New Combination Antiretroviral Pill – Abbott Laboratories announced last week that it will be developing a new combination antiretroviral pill consisting of Kaletra (lopinavir/ritonavir) and GlaxoSmithKline’s Epivir (lamivudine). According to Abbott, the proposed combination would reduce the number of pills patients have to take and would be more cost-effective than purchasing the medications separately. The combination pill would still need to be taken with at least one other antiretroviral. Abbott is also working on a powder (rather than liquid) formulation of Norvir (ritonavir), which could be added to food or drinks and may be easier for children to take. For more information, please see the Abbott Laboratories press release.

Gilead Sciences Agrees To License New HIV Drugs To Generic Drug Companies In Developing Countries – Gilead Sciences has signed agreements with several generic drug companies in India that will allow them to produce low-cost versions of the antiretrovirals Viread (tenofovir) and Emtriva (emtricitabine) for developing countries. The agreements will extend to the investigational drugs elvitegravir, cobicistat, and the combination “Quad” pill (cobicistat/elvitegravir/emtricitabine/tenofovir) if the drugs are approved. The agreement makes Gilead the first company to join the Medicines Patent Pool, an effort to bring newer antiretrovirals that are still under patent protection to people in developing nations. However, the agreement has faced criticism from Médecins Sans Frontières (also known as Doctors Without Borders) for excluding certain middle-income countries, such as Thailand and Brazil. For more information, please see the press releases from Gilead Sciences and Médecins Sans Frontières.

AIDSinfo Updates “HIV And Its Treatment” Factsheets – AIDSinfo, a website run by the Department of Health and Human Services (DHHS), has updated its factsheets on “HIV and Its Treatment” to include information from the latest DHHS treatment guidelines for adults and adolescents. The factsheets are intended for people with HIV and their friends or families and include information on current treatment recommendations, HIV testing, transmission prevention, and other topics. For more information, please see the updated factsheets (pdf) or the AIDSinfo website.

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[ by | Jun 28, 2011 1:57 pm | Comments Off ]
Tibotec, Gilead Announce Development Of New Combination Antiretroviral Pill

Tibotec Pharmaceuticals and Gilead Sciences have agreed to develop a new once-daily combination antiretroviral pill that combines the protease inhibitor Prezista with the investigational booster cobicistat.

In addition, the companies are currently in negotiations to develop a second pill combining Prezista, cobicistat, Emtriva, and an investigational new form of Viread called GS 7340.

“We are excited to be able to study and develop Prezista with an alternative boosting agent in a combination product which has the potential to reduce the number of tablets patients take,” said Dr. Johan Van Hoof, …

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[ by and | Jun 17, 2011 5:25 pm | Comments Off ]
Better Assessment Of Drug Resistance May Improve Treatment Of People With HIV

Results from a recent small Spanish study indicate that a more sensitive technique for detecting drug resistance, called deep sequencing, more accurately identified drug resistance in HIV-positive individuals who had previously been treated with antiretrovirals and were suffering from drug failure.

“Our study suggests that more sensitive genotypic HIV drug resistance assays, such as deep HIV sequencing, may help clinicians design antiretroviral treatment combinations better suited for [patients] infected with multidrug-resistant viruses,” said Dr. Roger Paredes, a key investigator of the study, in correspondence with The AIDS Beacon.

“Deep sequencing …

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