Ryan White Funding Delays

Errors in a public notice last week in New Orleans have forced city officials to delay the start of the 2009 process for distributing an expected $5 million in Ryan White Program funding for local HIV/AIDS agencies, the New Orleans Times-Picayune reports. The announcement of the delay comes after Fran Lawless -- who serves as director of Mayor Ray Nagin's Office of Health Care Policy -- in October testified before the city council's Housing and Human Needs Committee that 2008 funding distribution was delayed by six months and that service providers went without funding from March to October.

According to the Times-Picayune, City Council member Arnie Fielkow called on officials to begin the application process for 2009 earlier in the year. In an effort to meet this request, officials listed a public request for proposals in the Times-Picayune on Dec. 8, 9 and 10, which set the deadline for picking up applications as Dec. 5 -- a date that had already past. The deadline for submission also was listed incorrectly in the electronic notice sent directly to the service providers, which left many of them confused, according to the Times-Picayune. Carlos Butler -- Health Policy office manager and the contact who was listed in the public notice -- said that the request for proposals was canceled and referred questions to Lawless and a Nagin spokesperson, who did not respond to requests for comment, the Times-Picayune reports.

Several agencies that receive funding to provide assistance to more than 4,000 people living with HIV/AIDS in the city complained in October that they would be unable to operate if their funding continued to face delays as it had in 2008, according to the Times-Picayune. Doug Morgan, who administers Ryan White Program funding for the federal Health Resources and Service Administration, said, "Our hope is that some of the issues they faced in [2008] will not be repeated in [2009]." He added, "I'm unhappy to learn the initial draft of the (requests for proposal) had glitches in it. It sounds like they're close to repeating some of the timelines they had last year, and that makes me a little nervous."

A new notice appeared Tuesday in the Times-Picayune and the deadline for submitting requests was listed as Jan. 9. The notice also will appear Wednesday and Thursday in the newspaper. Dave Munroe of In This Together -- a not-for-profit agency serving 225 patients that was forced to shut down over the summer because of the delay in funding and reopened in October -- said that the agency will not apply for 2009 funding because of "continuing issues of truthfulness, transparency and professionalism" at the city level (Hammer, New Orleans Times-Picayune, 12/17).

In the event that funding runs out, and you require alternatives, please visit www.aids-drugs-online.com

Isentress More Effective in Un-Treated Patients

Merck's antiretroviral drug Isentress suppresses levels of HIV in previously untreated patients better than the company's antiretroviral efavirenz, according to research presented Sunday at a meeting of the American Society of Microbiology and the Infectious Diseases Society of America, Reuters reports. According to Phase III clinical trial results, Isentress -- known generically as raltegravir -- reduced HIV viral loads to undetectable levels in 86% of patients compared with 82% of patients treated with efavirenz (Fox, Reuters, 10/26).

FDA in October 2007 approved raltegravir for use by HIV-positive people who have not responded to other treatments. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA (Kaiser Daily HIV/AIDS Report, 10/15/07). The agency also granted Isentress accelerated approval for use among patients who showed initial signs of resistance to existing antiretrovirals. According to Merck, up to 40% of the approximately 500,000 HIV-positive people in the U.S. receiving antiretrovirals have developed resistance to the drugs. In addition, researchers at the conference said that drug-related adverse effects were significantly fewer in patients treated with Isentress (44%) than with efavirenz (77%) (AFP/Yahoo! News, 10/26).

Robin Isaacs, executive director for infectious disease clinical research at Merck, said, "There was a desperate unmet medical need for those patients who had failed other therapies" until recent years. He added that Isentress and Pfizer's Selzentry -- also approved last year -- helped address that need, along with three other new drugs: Boehringer Ingelheim's Aptivus, and Johnson & Johnson's Prezista and Intelence. According to Isaacs, patients "have all these different options now, which they didn't before, to build new successful regimens."

According to AP/Yahoo! Finance, Pfizer at the conference also presented research from a 48-week study comparing its antiretroviral Selzentry with Bristol-Myer Squibb's antiretroviral Sustiva in a total of 417 patients also receiving GlaxoSmithKline's antiretroviral combination drug Combivir. In both groups, 68% of patients had the HIV virus reduced to undetectable levels; however, 4.2% of those who got Selzentry and 14.2% taking Sustiva stopped because of side effects (Johnson, AP/Yahoo! Finance, 10/26).