FEBRUARY 2005
In The News
Study Details Effects of ART on Liver Disease
Liver disease has emerged as a leading cause of death among persons co-infected with HIV and HCV. A recent study estimated the burden of liver disease and evaluated determinants of liver fibrosis and necroinflammatory activity among HIV/HCV co-infected patients receiving antiretroviral therapy (ART). One-hundred twelve randomly selected and 98 referred HCV-infected patients undergoing care in an HIV clinic were studied. All patients had liver biopsies performed between April 2001 and July 2002, and had not received treatment for HCV infection prior to biopsy. Sixty-four percent of patients were receiving ART at the time of liver biopsy and 12% of patients had a previous episode of grade 3 or 4 ART-associated liver enzyme elevation. No hepatic fibrosis was detected in 33% of individuals, 41% had fibrosis restricted to the portal tracts, and bridging fibrosis and cirrhosis were noted in 9% and 17% of individuals, respectively. The median necroinflammatory activity score was 3, and 58 individuals had activity scores of 5 or higher. Individuals with persistently elevated ALT and/or AST levels, defined as having more than 1 in every 3 ALT or AST measurements >100ul, had a five-fold greater risk of bridging fibrosis or cirrhosis, compared with persons with lower liver enzyme levels. While this study found no evidence that ART caused serious histological liver disease, it was found that individuals with longer cumulative exposure to ART had significantly less necroinflammatory activity.
Hepatology. 41(1); January 2005.
FDA Approves New 500mg Invirase
The FDA recently approved a new 500mg, film-coated tablet formulation of the HIV protease inhibitor Invirase (generic name, saquinavir), designed for use in combination with ritonavir and other anti-HIV drugs for the treatment of HIV infection. The approval was based on data that show that similar drug levels are achieved with Invirase 500mg tablets and Invirase 200mg tablets, when each is administered with ritonavir 100mg and taken with food. The new formulation of Invirase will reduce pill count from five pills to two, twice daily, in hopes of improving patient adherence.
www.natap.org
Research: Low Rate of Treatment Failure with Tenofovir, Lamivudine, Zidovudine
Triple NRTI regimens combining tenofovir, lamivudine (3TC), and abacavir or didanosine have recently shown high rates of virologic failure, most often associated with the K65R resistance mutation. However, the inclusion of zidovudine may be protective against virologic failure and selection of the K65R mutation. Data was collected retrospectively from 40 patients who had previously been prescribed ART consisting of tenofovir, 3TC, and zidovudine. Baseline was considered the time immediately before each patient switched to the ART regimen consisting of tenofovir, 3TC, and lamivudine. At baseline, 27 patients' (group 1) HIV RNA levels were undetectable (<50 copies/ml) and 13 patients (group 2) had detectable HIV RNA levels ranging from 200-398,000 copies/ml. At the time of analysis, all patients had completed at least 24 weeks after initiation of treatment. Upon analysis, HIV RNA level was less than 50 copies/ml in 23 of 27 patients who had undetectable HIV RNA at baseline, and in 8 of 13 patients with detectable HIV RNA levels at baseline. The median CD4 cell counts in group 1 and 2 increased from 415 cells/ul to 595 cells/ul and from 354 cells/ul to 407 cells/ul, respectively. All nine patients who showed a virologic failure on tenofovir, 3TC, and lamivudine were genotyped for resistance. Two patients admitted to not having taken medication regularly. Of the seven remaining patients, the K65R mutation was detected in only one patient.
AIDS. 19(1); January 2005.
FDA Recommends Not Using Indinavir in Pregnant Women
The clinical pharmacology section of the Crixivan (Indinavir, IDV) label has been revised to include pharmokinetic data from a study in HIV-infected pregnant women, that showed results of significantly reduced IDV concentrations in women at 30-32 weeks gestation compared to levels post-partum. Based on these data, IDV is not recommended in HIV-infected pregnant patients.
FDA issued report; Dec 27, 2004.
CDC Recommends HIV Drugs for All Those Exposed
The CDC recently issued new recommendations that people exposed to HIV from non-occupational exposure, such as sexual assault, accidents, occasional drug use, or unsafe sex, receive antiretroviral medications to stave off HIV infection. Previously, the recommendations for emergency drug treatment were only for healthcare workers who with parenteral exposure through needlestick injuries, splashed to mucous membrane, or other occupational exposure. This recommendation was first made in 1996. However, the CDC has stated that "the severity of the HIV epidemic dictates we use all available tools to reduce infection." The new approach, called non-occupational post-exposure prophylaxis (NPEP) involves taking a daily antiretroviral regimen, which must begin within 72 hours after exposure and continue for 28 days. While NPEP is an important expansion of current HIV prevention strategies, it should not be viewed as the first line defense against HIV.
www.natap.org
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