Medical HIV News Briefs Archives

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to summaries from the CDC HIV/STD/TB Prevention News Update and aidsmap, a website of NAM a UK-based organization,
and links to Kaiser HIV/AIDS Report, The Body, Medscape and other sources. See also Medical News on Hepatitis, STDs, and TB

FDA WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS - See Drug Warnings
 

 April News Briefs

"Highly Active Antiretroviral Therapy Use and HIV Transmission Risk Behaviors Among Individuals Who Are HIV Infected and Were Recently Released from Jail" Am Journal of Public Health Vol. 98; No. 4: P. 661-666,
The authors evaluated highly active antiretroviral therapy (HAART) use and risk behaviors among 177 inmates who were HIV-infected and were released and then re-incarcerated in San Francisco jails during a 12-month period. A quarter of the adults who are HIV-infected in the United States pass through correctional facilities annually. CDC Summary

 Parkland Pocket Guide to HIV Care Now Available in Spanish
AIDSInfo At-a-Glance Volume 4 Issue 18
The Texas/Oklahoma AIDS Education and Training Center (TX/OK AETC) has released the Parkland Pocket Guide to HIV Care, 3rd Edition, in Spanish. This version of the guide provides effective HIV treatment information to clinicians, incorporating both U.S. and Mexican HIV/AIDS guidelines.

Tests Monitoring Viral Loads, CD4+ Count Do Not Significantly Affect Survival Rates Among HIV-Positive People, Study Finds
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51779
 

Researchers Develop Breath-Monitoring Device To Monitor Treatment Adherence Among HIV-Positive People
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51695
 

"HIV-Positive Smokers Considering Quitting: Differences by Race/Ethnicity"
Amer J of Health Behavior Vol. 32; No. 1: P. 3-15, (01.02.2008)
The authors’ objective in the current study was “to better characterize smoking in HIV-positive individuals and to identify critical components of a targeted smoking cessation intervention for multi-ethnic HIV-positive smokers.” CDC Summary

"Transmission of Drug-Resistant HIV-1 in Europe Remains Limited to Single Classes"
AIDS Vol. 22; No. 5: P. 625-635, (03.12.2008) The SPREAD Program
The objective of the current study was to analyze the “extent and impact of transmission of drug-resistant HIV-1 variants in Europe.” CDC Summary

Expanded HIV Testing -- Implementing the CDC Recommendations: Guidance for Nurses CE http://www.medscape.com/viewprogram/9090?src=mp&spon=24&uac=101151CR
 

ANTIRETROVIRAL THERAPY Updates from The Body
Latest HIV Research & News for Health Care Professionals: April 11, 2008
Could Nanotechnology Be the Next HIV Treatment Frontier?
To science-fiction aficionados, the phrase "nanotechnology" may conjure images of hordes of microscopic robots destroying humankind from the inside out. But within the field of HIV treatment research, the term inspires far more realistic imagery. Take, for example, a solution that combines antiretrovirals with tiny crystals so that when the solution is injected into a patient's bloodstream, it slowly breaks down over a period of weeks or even months, obviating the need for daily HIV therapy. This and other nanotechnologies are already under investigation in laboratory studies and early clinical trials, raising hopes for the development of ever-more-patient-friendly HIV treatment options.


Discordant Response to HAART May Increase Disease Progression Risk, Study Finds
HIV-infected patients who fail to achieve both an undetectable viral load and a CD4+ cell count increase within three to nine months after HAART initiation may face an increased risk of developing an opportunistic infection (OI) or dying, according to a University of Alabama study published in the April 15 issue of JAIDS. The retrospective study included 404 treatment-naive patients initiating therapy between 1995 and 2004; clinical outcomes were followed for a median of three years. Approximately one out of every four patients experienced a discordant response to their first three to nine months of therapy; these patients were 2.3 times more likely to die or develop an OI than patients with a concordant, successful response to HAART.
 

DHHS Adults and Adolescents Antiretroviral Treatment Guidelines Panel's Communication Regarding Abacavir - April 4, 2008
 AIDS At-A-Glance Volume 4 Issue 15 Report

Examination of Antiretrovirals Abacavir, Didanosine's Potential Link to Increased Risk of Heart Attack Continues
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51295

See March Medical Briefs Archives

Summaries

"Highly Active Antiretroviral Therapy Use and HIV Transmission Risk Behaviors Among Individuals Who Are HIV Infected and Were Recently Released from Jail" Am Journal of Public Health Vol. 98; No. 4: P. 661-666, (04..2008) Kristen Clements-Nolle, PhD, MPH; Rani Marx, PhD, MPH; Michael Pendo, MPH; Eileen Loughran, BA; Milton Estes, MD; Mitchell Katz, MD
The authors evaluated highly active antiretroviral therapy (HAART) use and risk behaviors among 177 inmates who were HIV-infected and were released and then re-incarcerated in San Francisco jails during a 12-month period. A quarter of the adults who are HIV-infected in the United States pass through correctional facilities annually.

Interviews with study participants assessed sociodemographics, incarceration history and use of supportive services the month preceding re-incarceration. They were also screened for depression, and questioned about past or present alcohol dependence and sexual and drug use behaviors. Participants were given a pill card with pictures to determine antiretroviral use during the preceding month and asked about doses missed.

In general, participants were economically disadvantaged and repeat incarceration was common. A majority were homeless the month preceding incarceration. Risk-taking behavior included sero-discordant unprotected sexual intercourse (27 percent-38 percent) and syringe sharing (17 percent). Although almost two-thirds had a history of antiretroviral use, 59 percent (n=64) of this group did not use HAART the month preceding incarceration. Among HAART users, 52 percent missed medication doses once a week or more.

The discontinuation of HAART was independently associated with homelessness, marijuana use, injection drug use, and the lack of community medical care.

According to the authors: “Suboptimal HAART use while in the community compromises the personal health of ex-offenders and may increase HIV transmission, including transmission of drug-resistant strains. This is particularly troubling given the rates of serodiscordant unprotected sexual intercourse and distributive syringe sharing we observed and others have reported.”

The authors concluded that the study results “highlight the need for coordinated public health interventions that begin during incarceration and continue post-release. Such interventions are critical to improving health outcomes for inmates who are HIV-infected and preventing further HIV transmission in the community.”
 

UNITED STATES:
 "HIV-Positive Smokers Considering Quitting: Differences by Race/Ethnicity"
Amer J of Health Behavior Vol. 32; No. 1: P. 3-15, (01.02.2008) Elizabeth E. Lloyd-Richardson, PhD; Cassandra A. Stanton, PhD; George D. Papandonatos, PhD; Renée M. Betancourt, BA; Michael Stein, MD; Karen Tashima, MD; Kathleen Morrow, PhD; Raymond Niaura, PhD
The authors’ objective in the current study was “to better characterize smoking in HIV-positive individuals and to identify critical components of a targeted smoking cessation intervention for multi-ethnic HIV-positive smokers.”

In 444 HIV-positive smokers, differences in baseline characteristics were examined by race. A multivariate linear regression model evaluated factors associated with nicotine dependence in an HIV-positive population, with a particular focus on race/ethnic differences.

The results showed that low smoking self-efficacy and higher contemplation of quitting were predictive of greater nicotine dependence. Of note was an interaction between age and race, with older Hispanic Americans less likely to be nicotine-dependent.

“Efforts should be made to tailor smoking cessation intervention content to HIV-positive racial/ethnic minority groups,” the authors concluded.
 

DHHS Adults and Adolescents Antiretroviral Treatment Guidelines Panel's Communication Regarding Abacavir - April 4, 2008
 AIDS At-A-Glance Volume 4 Issue 15

Data from studies addressing the safety of abacavir (ABC) and efficacy of abacavir/lamivudine (ABC/3TC) as part of a combination antiretroviral regimen recently became available.

At the 15th Conference on Retroviruses and Opportunistic Infections (CROI), the D:A:D study group reported their analysis of association of NRTI use and risk of myocardial infarction (MI) in a large multi-national observational cohort.1 Among the 33,347 patients enrolled, with 157,912 person-years follow-up, 517 subjects were diagnosed with an MI; 192 and 124 of these subjects reported use of ABC and didanosine (ddI), respectively, within the previous 6 months of the occurrence of the MI. In this analysis, recent (within 6 months) but not cumulative or past use (last use >6 months) of either ABC or ddI predicted risk of MI (relative risk of 1.94 [95% CI: 1.48-2.55] for ABC and 1.53 [95% CI: 1.10-2.13] for ddI). The heightened risk of MI with recent ABC exposure was accentuated in subjects with pre-existing cardiac risk factors (as defined by 10-year predicted coronary heart disease risk >20%). Use of tenofovir (TDF) or emtricitabine (FTC) was not analyzed in this study. 

A separate analysis conducted by GlaxoSmithKline using their internal database containing data from 54 clinical trials and post-marketing reports identified 9,369 patients who received ABC for 7,845 person-years and 5,044 patients who did not receive ABC with 4,653 person-years follow-up. Eleven ABC-treated and seven subjects not on ABC were reported to have an MI during the follow-up period.2 GlaxoSmithKline did not find any evidence of an increase in cardiovascular disease in their clinical trials among patients who received ABC. It should be noted that these studies were not designed to evaluate cardiovascular events as secondary endpoints, and the follow-up periods in these trials were 24-48 weeks.

On February 28, 2008, the National Institute of Allergy and Infectious Diseases released an announcement regarding a modification of the AIDS Clinical Trial Group (ACTG) 5202 study, a randomized controlled trial of antiretroviral-naïve participants evaluating the efficacy and safety of ABC/3TC vs. TDF/FTC when used in combination with either efavirenz (EFV) or ritonavir (RTV)-boosted atazanavir (ATV).3 Treatment randomization was stratified based on screening HIV RNA of <100,000 copies/mL or >100,000 copies/mL. Over 1,800 participants enrolled in this study. At a planned interim meeting of the independent Data Safety Monitoring Board (DSMB), the board noted that the majority of patients in all treatment arms had good virologic responses. The DSMB noted that among the participants with screening HIV RNA >100,000 copies/mL, those who were randomized to ABC/3TC had a significantly shorter time to study-defined virologic failure than those randomized to the TDF/FTC arm, regardless of whether they were using EFV or RTV-boosted ATV in combination. The DSMB also noted that within the stratum of subjects with a screening HIV RNA level >100,000 copies/mL, the ABC/3TC group had a shorter time to development of certain grade 3 or 4 side effects, including body aches and laboratory abnormalities such as lipid elevations. Based primarily on the difference in virologic efficacy, the DSMB recommended unblinding of the subjects who had screening HIV RNA >100,000 copies/mL, and counseling subjects on ABC/3TC about the findings, giving them the option to switch to other regimens. Subjects with HIV RNA <100,000 copies/mL at study screening are to remain blinded to their NRTI assignment. 

The results of the HEAT study, a head-to-head trial of 688 subjects comparing ABC/3TC to TDF/FTC, (both in combination with once-daily lopinavir/ritonavir) were presented at the 15th CROI.4 A subgroup analysis according to baseline HIV RNA < or >100,000 copies/mL (43% and 57% of subjects, respectively) yielded similar percentages of subjects with HIV RNA <50 copies/mL at 48 weeks for the two regimens: 71% (ABC/3TC) vs. 69% (TDF/FTC) for those with baseline HIV RNA <100,000 copies/mL and 63% vs. 65% for those with HIV RNA >100,000 copies/mL.

At this point, the Panel concludes that the preliminary information available from these studies does not warrant a change in its current recommendations regarding the use of antiretroviral drugs in adults and adolescents. The Panel will continue to review additional data as they become available and will make further recommendations if needed. Meanwhile, the Panel recommends clinicians consider all available information so that the optimal therapeutic choice for each patient is based on individual patient characteristics and the potential risks and benefits of each treatment component.

References:
  1. D:A:D Study Group.  Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration.  Lancet 2008; DOI:10.1016/S0140-6736(08)60423-7.  Available at http://www.thelancet.com. (Accessed April 2, 2008)
     
  2. Cutrell A, Brothers C, Yeo J, Hernandez J, Lapierre D.  Abacavir and the potential risk of myocardial infarction. Lancet 2008;  D01:10.1016/S0140-6736(80)60492-4. Available at http://www.thelancet.com. (Accessed April 2, 2008)
     
  3. NIAID Bulletin: NIAID modifies HIV antiretroviral treatment study: Combination therapy that includes ABC/3TC found less effective in subgroup of antiretroviral-naïve individuals. February 28, 2008. http://www3.niaid.nih.gov/news/newsreleases/2008/actg5202bulletin.htm.
     
  4. Smith K, Fine D, Patel P, et al. Efficacy and safety of abacavir/lamivudine compared to tenofovir/emtricitabine in combination with once-daily lopinavir/ritonavir through 48 weeks in the HEAT Study. Program and Abstract: 15th Conference on Retroviruses and Opportunistic Infections.  Boston, MA, February 3-6, 2008. Abstract 774.

A copy of this communication is available for download at AIDSinfo.

 

EUROPE:
 "Transmission of Drug-Resistant HIV-1 in Europe Remains Limited to Single Classes"
AIDS Vol. 22; No. 5: P. 625-635, (03.12.2008) The SPREAD Program
The objective of the current study was to analyze the “extent and impact of transmission of drug-resistant HIV-1 variants in Europe.”

The European prospective program (SPREAD) obtained demographic, clinical and virological data on 1,245 HIV-1-infected persons in 17 countries diagnosed between 2002 and 2003. Genotypic interpretation algorithms were used to determine the potential impact of transmitted drug resistance mutations (TDRMs) on therapy response.

Overall, 9.1 percent (96/1,050;95 percent confidence interval:7.5-11.1) of viruses had drug-resistance mutations. The majority (71 percent) harbored only a single amino acid substitution with limited effect on predicted drug susceptibility. Mutations associated with resistance to nucleoside reverse transcriptase inhibitors were observed most frequently [57/1,050 (5.4 percent)], followed by protease inhibitor-related mutations [32/1,050 (3.0 percent)] and mutations linked to non-nucleoside reverse transcriptase inhibitors (NNRTIs) [27/1,050 (2.6 percent)].

However, resistance was quite extensive in some cases. Four individuals were infected with viruses with reduced susceptibility to all nucleoside reverse transcriptase inhibitors, three to all protease inhibitors and 20 to both NNRTIs. In one individual, the resistance pattern was so extensive that none of currently available antiretroviral was predicted to be fully active.

“The prevalence of TDRM-HIV is quite prominent (9.1 percent) but did not increase in comparison with a large retrospective European study,” the report concluded. “Particularly the presence of single NNRTI mutations may impact the efficacy of the first-line regimens. Continuous prospective monitoring remains indicated to explore the patterns and factors contributing to the transmission of TDRMs as well as the potential clinical consequences.”

 
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