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OCTOBER & NOVEMBER 2007
News and Literature Reviews
FDA Approves Raltegravir as First in New Class of Antiretrovirals The U.S. Food and Drug Administration approved the use of raltegravir tablets in treating infections of HIV-1 in treatment-experienced individuals. The approval of raltegravir offers hope to individuals who have evidence of resistance to other antiretroviral drugs and represents one of a handful of new classes of antiretroviral drugs that have been approved in recent months. Raltegravir, which received a priority review by the FDA, is the first in a new class of antiretroviral drugs, known as HIV integrase strand transfer inhibitors that are designed to interfere with the enzyme that HIV-1 needs to multiply. Raltegravir was approved for use in treatment-experienced patients after the review of data from two double-blind, placebo-controlled studies in 6 99 HIV-1 infected patients with a history of extensive antiretroviral treatment and evidence of resistance to at least one antiretroviral drug. Individuals who received raltegravir in combination with other antiretrovirals experienced lower plasma HIV viral loads when compared to individuals who received a placebo in combination with other antiretroviral drugs. This trial did not include the use of raltegravir in persons less than sixteen years of age or in pregnant women. Some of raltegravir’s most common side-effects include diarrhea, nausea, and headache, along with elevated levels of CPK. U.S. Food and Drug Administration. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01726.html. Rapid Fibrosis Progression Among HIV/Hepatitis C Virus Co-infected Adults Between 15-30% of all HIV-infected individuals are also co-infected with hepatitis C (HCV) and HCV-related liver disease has grown to become a leading cause of death among persons infected with HIV. Recent studies have sought to examine possible links between the use of HIV antiretroviral drugs and the progression of HCV-related liver disease. Some retrospective studies have found a lower prevalence of cirrhosis and mortality in HCV-infected individuals who were receiving antiretroviral treatment for HIV-infection. Other studies have demonstrated an association between antiretroviral use and acute and chronic liver inflammation. To examine the pace of fibrosis progression in HIV-HCV co-infected patients and identify predictors of fibrosis advancement, the medical records of 184 HIV/HCV co-infected individuals from the Johns Hopkins University HIV clinic cohort with at least two liver biopsies performed between January 1998 and July 2006 were studied. The majority of patients were African American men and past or active drug use was reported in 78% of all patients. Nearly a quarter of co-infected patients in this study had evidence of significant fibrosis progression over a three-year interval. Antiretroviral and HIV disease measures were not associated with liver disease progression. Moreover, this study did not find evidence of long-term liver injury as a result of antiretroviral treatment. Only elevated levels of serum AST (but not ALT) between biopsies was shown to be an independent indicator of liver-disease progression. Rapid fibrosis progression among HIV/hepatitis C virus-co-infected adults. Sulkowski, M. et al. AIDS. 2007;21:2209-2216. ACLU’s Efforts Lead to More Equal Treatment of HIV-Positive Prisoners in Alabama After years of advocacy, the American Civil Liberties Union (ACLU), Alabama state legislators, and the AIDS service organization AIDS Alabama, have made headway with the Alabama Department of Corrections (ADOC) to allow HIV-positive prisoners greater access to educational programs, visitation, substance abuse treatment programs, and religious services. These programs and services have historically been denied to HIV-positive inmates. This decision comes after a letter from the ACLU was sent to ADOC Commissioner Richard F. Allen. The letter urged Commissioner Allen to put a stop to the discriminating segregation policies at the ADOC. Alabama remains the only state in the union to segregate HIV-positive prisoners and deny them access to programs and services available to the greater prisoner population. Before the changes, HIV-positive inmates at the Julia Tutwiler Prison for Women and the men’s Limestone Correctional Facility were completely isolated from the general population and given limited access to family visits, library, work opportunities, other services available to the general population. Since 1997, the ACLU, and advocates for people living with HIV have lobbied against these policies in two trials in the Eleventh Circuit Court of Appeals and the Alabama Supreme Court. The campaigns led to the release of a major report by the Alabama’s Governor’s HIV Commission for Children, Youth, and Adults, finding that there was overwhelming evidence to suggest that the segregation policies had no public health or safety justification. HIV-Positive Prisoners Receive More Equal Treatment in Alabama After ACLU's Efforts. (11/1/2007). http://www.aclu.org/prison/restrict/32510prs20071101.html Trends in HIV Testing and Differences Between Planned and Actual Testing in the United States, 2000-2005 Researchers at the Duke University Health Inequalities Program recently conducted a pooled cross-sectional analysis of data from the 2000-2005 National Health Interview Surveys (NHIS) in order to examine longitudinal trends in planned and actual HIV testing. The study, which appeared in the Archives of Internal Medicine, pooled data from six consecutive nationally representative cohorts of adults participating in the NHIS and examined the relationship between HIV testing rates and self-reported risk of HIV. Researchers also focused on understanding the relationship between planned and actual testing, as well as how demographic characteristics, HIV risk, and other health behaviors might impact testing rates. The researchers found that rates of HIV testing remained low and relatively unchanged during the six year span of this study’s data. Minority women had both the highest rates of lifetime HIV tests and the highest rates for HIV tests in the past twelve months. Conversely, white men were found to have both the lowest rates of lifetime HIV tests and the lowest rates for HIV tests in the past twelve months. The study also reported both white and minority women as having modest increases in lifetime HIV testing rates. Over 60% of participants who reported a specific HIV risk factor or had high current risk had ever been tested for HIV and more than twenty-percent of this group reported having been tested for HIV in the past year. Of all of the respondents who had previously been tested for HIV, 23.7% had a reason for getting tested for HIV, whereas 44.2% of tests had been administered as a part of routine care. In addition, 20.9% of tests were conducted to fulfill an insurance, marriage, immigration, or military requirement. Also, more than one-sixth of HIV tests were related to prenatal care.These findings are significant as they demonstrate the effectiveness of incorporating HIV testing into routine health care, as is recommended by the Centers for Disease Control and Prevention. Trends in HIV Testing and Differences Between Planned and Actual Testing in the United States, 2000-2005. Ostermann, J. et al. Arch Intern Med. 2007;167:2128-35. Compiled by Christine Devore
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