FDA Approves Viracept® 625 mg Tablets
The Food and Drug Administration recently approved a new alternate dosing formulation of Viracept® (nelfinavir mesylate). The new formulation of 625 mg reduces the pill burden from five 250 mg tablets bid to two 625 mg tablets bid, potentially facilitating adherence to treatment regimens. It is recommended that Viracept® be taken with a meal. Both retail and correctional pharmacies will have the product in stock as of June 1, 2004.www.viracept.com
National HCV/HIV Coinfection Coalition Meets Capitol Hill
was among the several HCV/HIV coinfection advocacy groups represented at the National HIV/Hepatitis C Coinfection Coalition's first round of visits to key House and Senate members on April 6 and 7, 2004. At the core of the Coalition's message was increased funding for programs that address the specific needs of coinfected individuals. Incorporating specific language on HCV/HIV coinfection into the Ryan White Care Act (RWCA) was identified by the Coalition as the most effective vehicle for attaining this goal. The Coalition also advocated for available funding for testing, the implementation of an effective referral system for co-infected patients, and increased funding for ADAPs (AIDS Drug Assistance Programs) so they can incorporate drugs to treat co-infection into their formularies. It is estimated that 30% of the 900,000 HIV-infected individuals are co-infected with HCV, and this percentage is projected to be higher among those who access ADAP funding. Furthermore, it is estimated that 60-90% of those who acquired HIV through intravenous drug use are also HCV-infected. While ADAP does not cover incarcerated patients, the outcome of this issue will certainly have serious implications for the thousands of co-infected inmates released each year. While individual members of Congress supported the Coalition's arguments, the question of finding the money was a recurring issue for some. The outcome of the Coalition's efforts will be decided when RWCA comes up for reauthorization by the U.S. Congress later this year, marking the third round of negotiations for reauthorization of the government's landmark legislation dealing specifically with HIV/AIDS care.Julia Noguchi, Managing Editor, HEPP Report
HAART With PI Less Likely to Show Liver Fibrosis
In a cross-sectional Spanish study of HIV/HCV coinfected patients from a cohort of HIV-infected patients, authors found that the use of HAART regimens including nevirapine is associated with an increased degree of liver fibrosis in HIV-infected patients with chronic HCV. Toxicity related to nevirapine can include either an early idiosyncratic reaction or a late-onset cumulative toxicity, both of which might be implicated in the worsening liver fibrosis among HIV-infected patients with chronic HCV. Patients receiving a protease inhibitor (PI) were less likely to show liver fibrosis. The results of this study suggest that HAART including a PI may be more advantageous in terms liver fibrosis progression than nevirapine-based regimens in HCV co-infected persons. The associations found in this study have not been confirmed by randomized prospective studies with hard clinical end-points, such as development of decompensated cirrhosis or death attributable to liver failure.Macías, Juana et al. AIDS: Volume 18(5) 26 March 2004 pp 767-774.
Undetectable HIV Viral Load Slows Liver Disease Progression in HCV-HIV Co-infection
As reported at the European Association for the Study of the Liver Conference (EASL) -- Berlin, Germany, April 14-18, 2004, HCV-HIV co-infected patients with suppressed HIV RNA (<400 copies/ml) have a similar rate of fibrosis as HIV-negative patients with HCV. Co-infected patients with uncontrolled HIV viremia have more rapid fibrosis rates than both patients with suppressed HIV RNA and those who are HIV-negative. In co-infection, the rate of fibrosis is independently predicted by log HIV viral load, Ishak necro inflammatory score, and age at HCV infection; and not by CD4 cell count or alcohol use. Study authors suggest that in co-infected persons, consideration should be given to starting HAART earlier (when CD4 cells are <500) to slow HCV-related fibrosis.NATAP -- www.natap.org