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[ by and | May 2, 2011 2:22 pm | No Comment ]

Roche Updates Fuzeon Prescribing Information To Warn Of Increased Pneumonia Risk – Roche updated the prescribing information for Fuzeon (enfuvirtide) last week to include information on a possible increased risk of bacterial pneumonia. Results from a recent study showed that patients taking Fuzeon were at about a 30 percent higher risk of contracting pneumonia. Although Roche is not certain that the higher rate is due to Fuzeon treatment, the company recommends that patients taking the drug be carefully monitored for signs of pneumonia. For more information, please see the FDA website.

Abbott Agrees To Cut Kaletra Drug Price For ADAPs – Abbott Laboratories announced last week that it has agreed to cut the price of its protease inhibitor Kaletra (lopinavir/ritonavir) for government-funded AIDS Drug Assistance Programs (ADAPs). Abbott will reduce the price of Kaletra by 8 percent to $5,037 per patient per year. ADAPs provide antiretroviral drugs to low-income people with HIV who cannot afford their medications. Due to the recession, many state ADAPs have been faced with budget cutbacks and increasing enrollment. According to the National Alliance of State and Territorial AIDS Directors, as of April 22, there were 7,674 people on ADAP waiting lists nationwide. For more information, please see the article in the Chicago Tribune.

Federal Judge Orders New York City To Restore AIDS Funding – A federal judge has ruled against a plan by New York City to cut funding for the city’s HIV/AIDS Service Administration (HASA). The proposed cuts would have eliminated 254 case managers from HASA’s staff. The judge ruled that the cuts violated New York City Local Law 49 and a federal court order that require HASA to maintain a case manager to client ratio of 1 to 34. The judge informed lawyers representing the city that they have 30 days to show that the budget cuts to HASA will not occur. For more information, please see the Housing Works press release.

Tobira Therapeutics Recruits Participants For Phase 2 Clinical Trial For CCR5 Inhibitor Cenicriviroc – Pharmaceutical company Tobira Therapeutics is currently recruiting participants to study the effectiveness, safety, and tolerability of its investigational CCR5 inhibitor cenicriviroc (TBR-652). Currently the only CCR5 inhibitor approved by the U.S. Food and Drug Administration is Selzentry (maraviroc). Participants will receive cenicriviroc plus Truvada (tenofovir/emtricitabine) or Sustiva (efavirenz) plus Truvada. The study is recruiting approximately 150 previously untreated HIV-positive adults. Trial locations include sites in Arizona, Florida, New York, and New Jersey. For more information, please see the U.S. Clinical Trials Registry.

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[ by | Jun 22, 2010 2:31 pm | 2 Comments ]
FDA Issues Urgent Recall For Roche Cobas Amplicor HIV-1 Monitor Test

The United States Food and Drug Administration (FDA) issued an urgent recall this month for Roche Diagnostics’ Cobas Amplicor HIV-1 Monitor Test, v1.5, due to invalid test results from faulty standardizing solutions.

The test is used by doctors to measure HIV viral loads, or the amount of virus present in the bloodstream. The FDA states that the problem causes an error that prevents the test from giving results.

The FDA advised customers to discontinue use of lot M02635, with an expiration date of June 30, and to contact Roche Molecular…

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