JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.
THIS WEEK'S CONTENT
JAMA NEWS RELEASES
(Embargoed for Early Release: 10:00 a.m. CT, Sunday, August 3, 2008)
JAMA NEWS RELEASES — HIV/AIDS THEME ISSUE
HIV TREATMENT WIDELY-USED IN DEVELOPING COUNTRIES MAY BE LESS EFFECTIVE WHEN USED WITH ANTI-TB THERAPY
INTERNATIONAL PANEL UPDATES TREATMENT GUIDELINES FOR HIV INFECTION
GROWTH HORMONE TREATMENT FOR HIV-RELATED ABDOMINAL OBESITY IMPROVES ABDOMINAL FAT AND OTHER CARDIOVASCULAR MEASURES, BUT MAY BE LIMITED BY EFFECTS ON GLUCOSE
HIGHLY ACTIVE ANTIRETROVIRAL THERAPY OF SIMILAR BENEFIT FOR HIV-INFECTED INJECTION DRUG USERS
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
HIV INFECTION RATES IN U.S. HIGHER THAN FIRST THOUGHT
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
TV Note: This week’s JAMA Report video, on the estimated incidence of HIV in the U.S., has an early embargo (11 a.m. ET Sunday, August 3) and two feeds this week: Sunday, August 3, 9:00 - 9:30 a.m. (ET) and 2:00 - 2:30 p.m. (ET); and Tuesday, August 5, 9:00 – 9:30 a.m. (ET) and 2:00 – 2:30 p.m. (ET), Galaxy 28, (C band) Transponder 19, Downlink frequency: 4080 Vertical ~ Audio: 6.2/6.8. For more information, call 312/464-JAMA.
The JAMA Report video will also be available post-embargo on The NewsMarket, at www.thenewsmarket.com/JAMA.
SAVE THE DATE: JAMA will present new research on HIV/AIDS at a media briefing on Sunday, August 3, at the International AIDS Conference in Mexico City. Program information will be included in a future email. To register, go to www.jamamedia.org and click on the Events tab.
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Embargoed for Early Release: 10:00 a.m. CT, Sunday, August 3, 2008
Media Advisory: To contact Andrew Boulle, M.B.Ch.B., M.Sc., email: andrew.boulle{at}uct.ac.za.
HIV TREATMENT WIDELY-USED IN DEVELOPING COUNTRIES MAY BE LESS EFFECTIVE WHEN USED WITH ANTI-TB THERAPY
MEXICO CITY—Patients receiving rifampicin-based anti-tuberculosis therapy are more likely to experience virological failure when starting nevirapine-based antiretroviral therapy, an HIV treatment that is widely used in developing countries because of lower cost, than when starting efavirenz-based antiretroviral therapy, according to a study in the August 6 issue of JAMA, a theme issue on HIV/AIDS.
Andrew Boulle, M.B.Ch.B., M.Sc., of the University of Cape Town, South Africa, presented the findings of the study at a JAMA media briefing on HIV/AIDS.
Combination antiretroviral therapy (ART) is frequently initiated in resource-limited countries when patients are being treated for tuberculosis. Co-administration of ART and anti-tubercular therapy may be complicated by shared toxicity or adverse drug interactions, according to background information in the article. Rifampicin-based anti-tubercular therapy reduces the plasma concentrations of the antiretroviral agents efavirenz and nevirapine. The virological consequences of these interactions are not well known.
Dr. Boulle and colleagues conducted a study to assess the effectiveness of efavirenz- or nevirapine-based combination ART used with rifampicin-based anti-tubercular therapy. The researchers analyzed clinical data collected from a community-based South African antiretroviral treatment program, in which adults were enrolled between May 2001 and June 2006 and were followed up until the end of 2006. The analysis included 2,035 individuals who started antiretroviral therapy with efavirenz (1,074 with tuberculosis) and 1,935 with nevirapine (209 with tuberculosis).
The researchers found that patients with tuberculosis initiating nevirapine were about twice as likely to have elevated viral loads during follow-up than those without tuberculosis (at six months, 16.3 percent vs. 8.3 percent). In the time-to-event analysis of confirmed virological failure, patients starting nevirapine with tuberculosis treatment were more than twice as likely to develop virological failure sooner. In spite of these differences, 80 percent of patients in the initial nevirapine-rifampicin group were virologically suppressed at 18 months duration of ART. There were no differences between patients starting efavirenz with and without tuberculosis treatment, or in patients developing tuberculosis while on nevirapine or efavirenz compared to those free of tuberculosis on the same antiretroviral drug.
The authors speculate that these differences, present in patients who start nevirapine-based antiretrovirals with tuberculosis, but not in those who develop tuberculosis once already established on nevirapine-based antiretroviral therapy “...could be the result of the limited power of the latter analysis to detect a difference… An alternative explanation, however, is a drug interaction mediated by rifampicin during the lead-in dosing phase of nevirapine.”
“Given the continued reliance on nevirapine-containing ART regimens in Africa, together with the important role tuberculosis services play as an entry point for ART, further prospective studies exploring this outcome are warranted. One of the most striking aspects of our study was the demonstration that 40 percent of patients starting ART in recent years have concurrent tuberculosis, underscoring the public health importance of improving affordable treatment options for patients infected with HIV and tuberculosis in this setting.”
(JAMA. 2008;300[5]:530-539. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Early Release: 10:00 a.m. CT, Sunday, August 3, 2008
Media Advisory: To contact Scott M. Hammer, M.D., call Karin Eskenazi at 212-305-6535.
INTERNATIONAL PANEL UPDATES TREATMENT GUIDELINES FOR HIV INFECTION
MEXICO CITY—An evaluation of recent data has led to an update in the guidelines and recommendations for antiretroviral treatment of adult human immunodeficiency virus (HIV) infection, according to an article in the August 6 issue of JAMA, a theme issue on HIV/AIDS.
Scott M. Hammer, M.D., of Columbia University College of Physicians and Surgeons, New York, and the International AIDS Society–USA Panel, presented the recommendations of the panel at a JAMA media briefing on HIV/AIDS.
The field of antiretroviral therapy continues to evolve rapidly, and, to maintain the highest possible standard of care, treatment guidelines must continually be refined to assist the complex decision-making process, according to the authors. “For a disease that has been transformed from almost uniformly fatal to manageable over decades, the impact of treatment decisions is substantial.” They add that the availability of new antiretroviral drugs and formulations, including drugs in new classes, and recent data on treatment choices for antiretroviral patients warrants an update of the International AIDS Society–USA guidelines.
Dr. Hammer and members of the panel analyzed new data in the field from the last two years to provide guidelines in key areas of antiretroviral management, including when to start therapy, choice of initial regimens, patient monitoring, and the approach to treatment failure. The latter emphasizes the role of recently approved drugs in assisting clinicians with constructing regimens that will keep HIV suppressed even in the face of multidrug resistant virus.
When to Start Antiretroviral Therapy
New data and considerations support initiating therapy before CD4 cell count declines to less than 350/µL. In patients with 350 CD4 cells/µL or more, patient readiness, drug interactions, adherence challenges, toxicities and cost should be considered when determining whether to initiate therapy. Rapid decline in CD4 cell count (i.e., more than 100/µL per year), a plasma HIV-1 RNA level more than 100,000 copies/mL, risk factors for cardiovascular disease, and the presence of certain other diseases (e.g., active hepatitis B or C virus co-infection and HIV-associated nephropathy [a disease affecting the kidneys]) should be considered in deciding whether to initiate therapy in patients with CD4 cell counts more than 350/µl.
What Antiretroviral Regimen to Start
The authors write that the initial regimen must be individualized, particularly in the presence of other existing illnesses, but usually will include efavirenz or a ritonavir-boosted protease inhibitor plus two nucleoside (or nucleoside plus nucleotide) reverse transcriptase inhibitors (nRTIs). Recommended nRTIs in the initial regimen are the fixed-dose combinations tenofovir/emtricitabine or abacavir/lamivudine. Simplicity of therapy, pill number, tolerability, desire for pregnancy, drug interactions and primary drug resistance are likely to influence the choice between these recommended options.
Patient Monitoring
The goal of antiretroviral therapy is to reduce and maintain a plasma HIV-1 RNA level of less than 50 copies/mL. Plasma HIV-1 RNA levels should be monitored frequently when treatment is started or changed for virologic failure (e.g., at 2, 4, 8, and every 4 weeks thereafter) until it reaches levels below the assay detection limits, and regularly thereafter (e.g., 3-4 times per year). Genotypic testing for drug resistance should be performed for certain patients. Appropriate assessment of other conditions and monitoring for toxicity should be performed before initiating treatment and during follow-up.
Changing Therapies
Virologic failure on an initial nonnucleoside reverse transcriptase inhibitor (NNRTI)- or ritonavir-boosted protease inhibitor-based regimen should be treated early with, ideally, three fully active drugs. For multi-drug resistance, three active drugs, including new classes of agents whenever possible, should be used.
The appropriate use of new agents, such as raltegravir (an integrase strand transfer inhibitor), maraviroc (a CCR5 antagonist), and etravirine (a “second generation” NNRTI), in combination with older agents can help achieve the goal of maintaining a plasma HIV-1 RNA level below 50 copies/ml even in patients with high degrees of treatment experience and multidrug resistant virus.
The authors write that despite advances in the treatment of HIV infection, “disease management remains challenged by toxicities, maintenance of adherence, clinical manifestations related to both the drugs and the HIV infection itself, and the threat of drug resistance. Sustainability and expansion of the progress achieved will depend on maintaining a robust drug development pipeline and the ability to deliver effective therapy and monitoring tools to the world’s affected populations.”
“With creativity and political will, the progress and individualized approach to antiretroviral therapy evident in the developed world can be adapted to the public health approach in the developing world, where 90 percent of the world’s HIV-infected population lives.”
(JAMA. 2008;300[5]:555-570. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Early Release: 10:00 a.m. CT, Sunday, August 3, 2008
Media Advisory: To contact Steven Grinspoon, M.D., call Sue McGreevey at 617-724-2764.
GROWTH HORMONE TREATMENT FOR HIV-RELATED ABDOMINAL OBESITY IMPROVES ABDOMINAL FAT AND OTHER CARDIOVASCULAR MEASURES, BUT MAY BE LIMITED BY EFFECTS ON GLUCOSE
MEXICO CITY—For human immunodeficiency virus (HIV)-infected patients with treatment-related abdominal obesity and growth hormone deficiency, receiving low-dose growth hormone resulted in improvement in fat and blood pressure measurements but worsened glucose levels, according to a study in the August 6 issue of JAMA, a theme issue on HIV/AIDS.
Steven Grinspoon, M.D., of Massachusetts General Hospital, Boston, presented the findings of the study at a JAMA media briefing on HIV/AIDS.
Patients with HIV infection treated with antiretroviral therapy frequently develop changes in body composition, such as abdominal obesity, and metabolic complications of dyslipidemia (disorders of lipoprotein metabolism, including high cholesterol levels) and insulin resistance, putting these patients at increased cardiovascular risk. Growth hormone (GH) secretion is reduced in patients with HIV and abdominal fat accumulation, and relative GH deficiency (GHD) is observed in approximately one-third of such patients, according to background information in the article. Some studies have indicated that doses of growth hormone could decrease abdominal fat.
Dr. Grinspoon and colleagues conducted a study to determine whether low-dose GH in 56 HIV patients with abdominal fat accumulation and GH deficiency would improve body composition, lipids, and other metabolic and cardiovascular measures. Patients were randomly assigned to receive by injection either GH or matching placebo. Fifty-five patients (26 with GH and 29 with placebo) were included in the safety analyses and 52 patients (25 with GH and 27 with placebo) were included in the efficacy analyses.
The researchers found that abdominal fat decreased significantly in the GH group compared with the placebo group, with a percentage change in the GH group of −8.5 percent and −1.6 percent in the placebo group. Trunk-to-lower extremity fat ratio and trunk fat also decreased in the GH group compared with the placebo group.
Triglycerides and diastolic blood pressure (BP) levels improved with GH, while the change in systolic BP was not statistically different compared with placebo. Total cholesterol and high density lipoprotein (HDL) cholesterol levels were unchanged between the two groups. GH increased glucose levels during glucose tolerance testing, however long-term indices of glucose, hemoglobin A1c (the substance of red blood cells that carries oxygen to the cells and sometimes joins with glucose), were not different between the groups.
“Data from our randomized, placebo-controlled trial involving a long duration of observation inject a note of caution into the debate regarding the use of GH therapy in the HIV population,” the authors write. “Low-dose physiological GH is well-tolerated and results in significant but more modest reduction in visceral adipose tissue [VAT; abdominal fat], but is nonetheless associated with increased glucose levels. Therefore, the therapeutic window to achieve an optimal risk-benefit ratio of GH in individuals with HIV, abdominal fat accumulation, and insulin resistance may be very narrow and difficult to achieve.”
“Growth hormone is not yet FDA-approved for the treatment of abdominal fat accumulation in patients with HIV. Other more potent strategies to safely increase GH and reduce VAT, including the use of GH-releasing hormone (GHRH), may be more beneficial. In addition, strategies using diet, exercise, and lifestyle change may be more cost-effective in the long run than GH, particularly in patients with HIV, visceral adiposity, and insulin resistance, in whom changes in glucose may be counterproductive,” the researchers conclude.
(JAMA. 2008;300[5]:509-519. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Early Release: 10:00 a.m. CT, Sunday, August 3, 2008
Media Advisory: To contact Julio S. G. Montaner, M.D., F.R.C.P.C., call Stephen Burega at 604-506-3734 or email: sburega{at}cfenet.ubc.ca.
HIGHLY ACTIVE ANTIRETROVIRAL THERAPY OF SIMILAR BENEFIT FOR HIV-INFECTED INJECTION DRUG USERS
MEXICO CITY – Contrary to the belief that HIV-infected injection drug users (IDUs) receive less benefit from highly active antiretroviral therapy (HAART), new research finds little difference in the survival rate between IDUs and non-IDUs after 4-5 years of receiving HAART, according to a study in the August 6 issue of JAMA, a theme issue on HIV/AIDS.
Julio S. G. Montaner, M.D., F.R.C.P.C., of the University of British Columbia and St. Paul’s Hospital, Vancouver, Canada, and President-Elect, International AIDS Society, presented the findings of the study at a JAMA media briefing on HIV/AIDS.
Since the mid-1990s, substantial reductions in illness and death related to the human immunodeficiency virus (HIV) have been documented among HIV-infected persons receiving HAART. “However, a large number of prior reports have demonstrated that because of issues of social instability related to illicit drug addiction, HIV-infected IDUs may not be deriving the full benefits of HAART,” the authors write. They add that other reports have shown that IDUs are less likely to be prescribed HAART and that a history of injection drug use was a predictor of worse outcome with HAART. However, long-term evaluations of HIV-treatment outcomes among IDUs in comparison with other risk groups have not been available.
Dr. Montaner and colleagues compared the rate of death between 3,116 patients with and without a history of injection drug use initiating HAART in a HIV/AIDS treatment program in British Columbia, Canada. Of the 3,116 patients, 915 were IDUs (29.4 percent). Treatment with HAART was initiated between August 1996 and June 2006. The median (midpoint) duration of follow-up was 5.3 years for IDUs and 4.3 years for non-IDUs. Patients were followed up until June 30, 2007.
During the study period 622 individuals died (20.0 percent; 232 IDUs and 390 non-IDUs). Through seven years after the initiation of HAART, the researchers found that the cumulative all-cause mortality rate was not statistically different between the 915 IDUs (26.5 percent) and 2,201 non-IDUs (21.6 percent). Further analysis also indicated similar rates of death for both groups, after adjustment for age, sex, baseline AIDS diagnosis, baseline CD4 cell count, adherence and physician experience.
“Although our findings cannot be generalized outside of [this] cohort, as efforts to improve use of HAART among IDUs expand, the fact that survival patterns were not significantly different between IDUs and non-IDUs should help to challenge the increasingly prevalent belief that IDUs may be markedly less likely to benefit from HAART. Based on these results, we conclude that HAART regimens may have effectiveness at a populational level that is not significantly different regarding the survival of individuals with and without a history of injection drug use,” the authors conclude.
(JAMA. 2008;300[5]:550-554. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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JAMA REPORTS
VIDEO: Windows Media | Quicktime
HIV INFECTION RATES IN U.S. HIGHER THAN FIRST THOUGHT
INTRO:
Researchers with the Centers for Disease Control and Prevention say there are more people newly infected with HIV each year in the U.S. than first thought. A new test applied to blood samples in the lab is able to help distinguish recent HIV infections from others acquired many years ago. Researchers say they now have a more accurate picture of the HIV epidemic. Jennifer Mitchell explains in this week’s JAMA Report.
VIDEO:
B-ROLL
People on street
FILE – lab video
AUDIO:
EVERY YEAR THOUSANDS OF NEW CASES OF HIV ARE REPORTED IN THE U.S. RESEARCHERS SAY THEY HAVE NEW INFORMATION INDICATING INFECTION RATES ARE HIGHER THAN FIRST THOUGHT.
VIDEO:
SOT/FULL
Super @:13
Irene Hall, Ph.D.
Centers for Disease Control and Prevention
Runs: 07
AUDIO:
“Our new estimate shows that the epidemic is and has been worse than we previously knew.”
VIDEO:
B-ROLL
Doctor walking
CDC exterior campus shots
Map: 22 states
FILE : lab video
AUDIO:
DOCTOR IRENE HALL IS CHIEF OF HIV INCIDENCE AND CASE SURVEILLANCE AT THE C-D-C IN ATLANTA. SHE AND HER COLLEAGUES ANALYZED DATA FROM THOUSANDS OF BLOOD SAMPLES COLLECTED IN THESE TWENTY-TWO STATES IN 2006. USING NEW TECHNOLOGY IN THE LAB THAT MEASURES A SPECIFIC HIV ANTIBODY IN THE BLOOD, RESEARCHERS ARE NOW ABLE TO DETERMINE WHETHER A PERSON HAS BEEN INFECTED WITH HIV WITHIN THE PAST FIVE MONTHS. THIS OFFERS A MORE ACCURATE ESTIMATE OF ANNUAL HIV INFECTION RATES.
VIDEO:
SOT/FULL
Irene Hall, Ph.D.
Centers for Disease Control and Prevention
Runs: 11
AUDIO:
“We now know that HIV infections were never as low as forty thousand per year. We estimate that about fifty thousand infections occurred per year in the early 1990s.”
VIDEO:
B-ROLL
People on street
GRAPHIC:
“56,300 New HIV Cases”
“53% Gay/Bi-Sexual Men”
“45% African Americans”
AUDIO:
THE STUDY ESTIMATES THAT IN 2006 THERE WERE ABOUT FIFTY-SIX THOUSAND THREE HUNDRED NEW HIV INFECTIONS IN THE UNITED STATES. FIFTY-THREE PERCENT OF NEW CASES OCCURRED AMONG MEN WHO HAVE SEX WITH MEN AND FORTY-FIVE PERCENT AMONG AFRICAN AMERICANS.
VIDEO:
SOT/FULL
Irene Hall, Ph.D.
Centers for Disease Control and Prevention
Runs: 05
AUDIO:
“We know that about eighty percent of men who have sex with men have not had intense prevention efforts that reached them in the past year.”
VIDEO:
B-ROLL
GXF/JAMA COVER
AUDIO:
THE STUDY APPEARS THIS WEEK IN A THEME ISSUE OF JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, DEVOTED TO HIV AND AIDS RESEARCH.
VIDEO:
SOT/FULL
Irene Hall, Ph.D.
Centers for Disease Control and Prevention
Runs: 10
AUDIO:
“These estimates are a wakeup call for us all. We need to do more as individuals, as communities and as a nation to increase testing and also to increase prevention efforts.”
VIDEO:
B-ROLL
FILE - blood in lab
Gay men blurred out
African American people on street blurred out
AUDIO:
BUT THAT CAN BE A CHALLENGE ESPECIALLY WHEN AN ESTIMATED TWENTY-FIVE PERCENT OF PEOPLE LIVING WITH HIV DO NOT KNOW THEY ARE INFECTED. JENNIFER MITCHELL THE JAMA REPORT.
TAG:
Currently there are more than one million people living with HIV in the United States. The study reveals that the number of new HIV infections increased during the mid-1990s but then declined slightly after 1999 and have been stable since then. Researchers say these figures give them the clearest picture to date of new infections in the U.S. For more information about this study you can log on to www.jama.com.
