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

FDA Approves Prezista for Use in Treatment Naive Individuals

FDA on Tuesday approved Johnson & Johnson's protease inhibitor Prezista for use by people who have never taken antiretroviral drugs in the past, the Wall Street Journal reports. FDA in 2006 approved Prezista for HIV-positive people who had developed resistance to other drugs. The agency also granted tentative approval for the drug as part of FDA's accelerated approval mechanism, which allows drugs to be sold while further studies are conducted. J&J obtained full approval for Prezista after submitting studies to FDA through this mechanism (Corbett Dooren, Wall Street Journal, 10/23).

According to J&J, patients beginning HIV treatment should take Prezista -- generically known as darunavir -- in combination with ritonavir. Ritonavir -- sold by Abbott Laboratories under the brand name Norvir -- works in combination with Prezista by slowing down the body's processing of the drug, Reuters reports (Reuters, 10/22). As a protease inhibitor, Prezista works by blocking a protein that HIV requires for replication. Treatment-naive HIV-positive people are recommended to take two 400 mg tablets of Prezista with 100 mg of ritonavir twice daily, and patients who have previously taken other HIV medications are recommended to take 600 mg of Prezista twice daily. J&J will discontinue the production of a 300 mg tablet following a decline in demand. According to the company, the wholesale price of the drug is about $740 monthly.

Glenn Mattes, president of J&J's Tibotec Therapeutics, said FDA approval of Prezista for newly diagnosed HIV-positive people "is a significant expansion of our ability to reach the entire population of patients who should be treated with a protease inhibitor." According to the AP/Boston Globe, during a study that compared Prezista with Kaletra -- a similar drug produced by Abbott -- 84% of patients treated with Prezista had HIV viral loads drop to an undetectable level, compared with 78% of patients taking Kaletra. However, this difference was not considered statistically significant (AP/Boston Globe, 10/22). Side effects of Prezista include diarrhea, headache, nausea, skin rash and, in some cases, hepatitis and liver failure (Reuters, 10/22).