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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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Alcohol Pads Packaged With Fuzeon May Be Contaminated – Genentech, the maker of anti-HIV drug Fuzeon (enfuvirtide), has stated that the alcohol pads packaged with Fuzeon may be contaminated and should not be used. Genentech recommends using a different alcohol pad or sterile gauze with isopropyl alcohol. The contamination does not affect Fuzeon itself, only the included alcohol pads. The alcohol pads are made by Triad Group, which has issued a recall on alcohol pads and swabs due to possible bacterial contamination that could lead to infections. For more information, please see the Genentech press release.

Florida ADAP Running Out Of Money For Anti-HIV Drugs – Florida’s AIDS Drug Assistance Program (ADAP) has run out of money and will need an additional $14.5 million before April if it is to continue running, according to state officials. Without additional funds Florida’s ADAP will have to stop providing anti-HIV drugs by next month. Florida has already instituted a waiting list for the program; at 2,500 people, Florida’s waitlist is larger than any other state’s. Officials have said unprecedented demand from people who have lost their jobs or insurance has strained the program’s finances. ADAP managers are looking to other government programs and assistance from pharmaceutical companies, charities, and other possible funding sources. For more information, please see the Highlands Today website.

French Doctor Calls For Creation Of International Coalition To Find A Cure For HIV – Dr. Alain Lafeuillade, chief of the department of infectious diseases at General Hospital in Toulon, France, has issued a call for the creation of an international agency dedicated to finding a cure for HIV. Dr. Lafeuillade states that costs for universal treatment of HIV are unreasonable and that government and private investors should focus instead on trying to cure HIV by eliminating latent HIV reservoirs – HIV that lies dormant and can start multiplying again if antiretroviral therapy is stopped. Current antiretrovirals cannot get rid of latent HIV. Dr. Lafeuillade argues that scientific breakthroughs have made such a cure feasible but need to be further pursued by creating an international agency dedicated to research on the topic. For more information, please see the press release by Dr. Lafeuillade.

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Several studies presented at the 2010 International AIDS Conference found that newer antiretrovirals, such as Isentress and Selzentry, are safe and effective at treating even multi-drug-resistant HIV.

However, one study that examined the efficacy of single versus double boosted protease inhibitors in adults with drug-resistant HIV found that double boosted protease inhibitors offered no additional benefits over single boosted.

Although antiretroviral therapy is usually highly successful at treating HIV, drug-resistant forms of the virus have emerged over time. Studies have suggested that about 15 percent of HIV strains show resistance…

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The National Institutes of Health (NIH) released new guidelines last week regarding treatment for pregnant HIV-positive women and prevention of mother-to-child transmission of HIV.

The guidelines include updates on preferred regimens for prevention of HIV transmission during pregnancy.

According to the report, fewer than 200 children are now born with HIV in the United States each year, as a result of efforts to limit mother-to-child transmission.

Transmission of HIV from a pregnant woman to her baby can occur during pregnancy, labor, or while breastfeeding after the baby is born. To…

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Brand Name:	Fuzeon
Generic Name:	enfuvirtide
Company:	Hoffmann-La Roche Inc. (Roche Pharmaceuticals)
FDA Clinical Phase:	Approved for use in 2003 in combination with other HIV drugs to increase CD4 cell count (“helper T-cells”) and decrease viral load (number of HIV copies in a blood sample).

Description

Fuzeon is the first fusion inhibitor approved by the U.S. Food and Drug Administration for patients who have already started antiretroviral therapy for HIV infection. Fusion inhibitors…