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. ET, Sunday, August 13, 2006)
JAMA NEWS RELEASES — Theme Issue on HIV/AIDS
NO ADVANTAGE FOR FOUR-DRUG ANTIRETROVIRAL REGIMEN VS. THREE-DRUG REGIMEN FOR INITIAL TREATMENT OF HIV-1
RAPID EXPANSION OF HIV TREATMENT SERVICES IN SUB-SAHARAN AFRICA FEASIBLE, WITH GOOD PATIENT OUTCOMES
STUDY SHOWS PROMISE FOR SIMPLIFIED TREATMENT OF HIV INFECTION
PANEL UPDATES GUIDELINES FOR TREATMENT OF ADULT HIV INFECTION
JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)
VIDEO: Windows Media | Quicktime
HIV TREATMENT REGIMEN WITH FOUR DRUGS NO BETTER THAN THREE-DRUG REGIMEN
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
Save the Date: JAMA will present new research on HIV/AIDS at a media briefing on Sunday, August 13, from 10 a.m. – 12:15 p.m., at the International AIDS Conference in Toronto. Program and registration information is included at the end of this email.
Please Note, Two VNR Feeds This Week, Sunday and Tuesday: This week's JAMA video news release is on the outcomes of three- vs. four-drug antiretroviral regimens for the initial treatment of HIV-1 infection. The release will be fed Sunday, August 13, from 10:00 - 10:30 a.m. ET and 2:00 - 2:30 p.m. ET, and on Tuesday, August 15, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band), Downlink Freq: 3920 MHz Vertical, Audio: 6.20/6.80. For more information, call 312/464-JAMA or 312/543-7655.
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Embargoed for Early Release: 10:00 a.m. ET, Sunday, August 13, 2006
Media Advisory: To contact Roy M. Gulick, M.D., M.P.H., call Jonathan Weil at 212-821-0566.
NO ADVANTAGE FOR FOUR-DRUG ANTIRETROVIRAL REGIMEN VS. THREE-DRUG REGIMEN FOR INITIAL TREATMENT OF HIV-1
TORONTO—Adding a fourth drug to an antiretroviral regimen for the initial treatment of HIV-1 did not lead to significant differences in reducing HIV levels in the blood, time to virologic failure, adverse events or drug resistance over 3 years, according to a study in the August 16 issue of JAMA, a theme issue on HIV/AIDS.
Roy M. Gulick, M.D., M.P.H., of Weill Medical College of Cornell University, New York, presented the findings of the study today at a JAMA media briefing at the International AIDS Conference in Toronto.
The current standard of care for initial treatment of human immunodeficiency virus 1 (HIV-1) infection is a three-drug antiretroviral regimen, which can suppress viremia (presence of HIV in the blood), increase CD4 cell counts, delay clinical progression, and improve survival, according to background information in the article. Some researchers have suggested that adding drugs to the 3-drug regimens could improve antiretroviral activity. However, additional drugs increase complexity, the potential for toxicity, and costs, and prior studies comparing 3- and 4-drug antiretroviral regimens have shown inconsistent results.
Dr. Gulick and colleagues conducted a study to determine whether a 4-drug regimen would demonstrate better antiretroviral activity than the standard 3-drug regimen. The AIDS Clinical Trials Group (ACTG) A5095 study included 765 HIV-1–infected patients who had not previously received treatment for HIV-1. The trial was a randomized, double-blind, placebo-controlled study, with enrollment and follow-up conducted from March 2001 to March 2005. The study participants received either the medications zidovudine/lamivudine plus efavirenz (3-drug regimen) or zidovudine/lamivudine/abacavir plus efavirenz (4-drug regimen).
Overall, 26 percent of 382 patients receiving the 3-drug regimen and 25 percent of 383 receiving the 4-drug regimen reached protocol-defined virologic failure; time to first virologic failure was not significantly different between the two study treatment groups. In subgroup analyses, increased risk for virologic failure was seen in non-Hispanic black patients. At 3 years, the HIV-1 RNA level was less than 200 copies/mL in 90 percent of 169 and 92 percent of 156 patients receiving the 3-drug and 4-drug regimens, respectively, and less than 50 copies/mL in 85 percent of 169 and 88 percent of 156 patients.
“We found no significant differences over 3 years between the standard 3-drug regimen of zidovudine/lamivudine plus efavirenz and the 4-drug regimen of zidovudine/lamivudine/abacavir plus efavirenz for the initial treatment of HIV-1 infection with regard to initial virologic response, time to virologic failure, CD4 cell count, adverse events, adherence, resistance mutations at virologic failure, or treatment or study discontinuation rates,” the authors write.
“High rates of virologic suppression achieved in this study support current guidelines that recommend 2 nucleosides plus efavirenz among preferred regimens for the initial treatment of HIV-1 infection. Adding abacavir as a fourth drug to the standard initial 3-drug regimen did not change toxicity or adherence but provided no additional benefit,” the researchers conclude.
(JAMA. 2006;296:769-781. 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. ET, Sunday, August 13, 2006
Media Advisory: To contact Jeffrey S. A. Stringer, M.D., call Patricia Edmonds at 703-999-3075.
RAPID EXPANSION OF HIV TREATMENT SERVICES IN SUB-SAHARAN AFRICA FEASIBLE, WITH GOOD PATIENT OUTCOMES
TORONTO—A massive scale-up of HIV/AIDS treatment programs at urban primary care sites in Zambia has produced favorable patient outcomes, demonstrating that expansion of such programs in sub-Saharan Africa is feasible, with good results, according to a study in the August 16 issue of JAMA, a theme issue on HIV/AIDS.
Jeffrey S.A. Stringer, M.D., of the Centre for Infectious Disease Research in Zambia, Lusaka, and the University of Alabama at Birmingham, presented the findings of the study today at a JAMA media briefing at the International AIDS Conference in Toronto.
Zambia’s 11.5 million residents are among the world’s poorest and most severely affected by acquired immunodeficiency syndrome (AIDS), according to background information in the article. About 16 percent of the adult population is infected with human immunodeficiency virus 1 (HIV 1), including 22 percent in the capital city Lusaka. In 2003, more than 90,000 Zambians died of HIV disease. Historically, only the wealthiest citizens have had access to antiretroviral therapy (ART) for HIV through private medical practices.
The Zambian Ministry of Health, aiming to provide public access to treatment, in 2002 started pilot ART distribution programs at two of the country’s largest hospitals. The program filled almost immediately and in May 2004 expanded to four clinics in the Lusaka Urban District, which were staffed primarily by clinical officers and nurses. In the following 18 months, all fees for patients seeking care were eliminated, ART and laboratory tests were offered for free and the program expanded to 14 additional urban sites. “At the time of program initiation, there was widespread uncertainty that complex, long-term HIV care could be delivered in a setting with so few physicians and so little physical and technical resources,” the authors write.
Dr. Stringer and colleagues report on their initial experience with the program and evaluate outcomes among more than 16,000 patients receiving ART at the 18 facilities between April 2004 and Nov. 2005. The study details survival, treatment failure rates and CD4 cell count response, a measure of the state of the immune system. The lower the CD4 count, the more likely a patient with HIV/AIDS is to develop secondary infections or illnesses.
More than 21,755 patients entered the program during the study period, 16,198 of whom received ART. A total of 1,142 patients receiving ART died; of those, 1,120 had a reliable date of death and 792 of those died within the first 90 days of beginning therapy. After the first 90 days, there were five deaths per 100 patient-years, comparable to rates in the developed world. CD4 cell responses also were similar to those in developed nations. Therapy failure was defined as a worsening stage of disease after three months of treatment or a return of CD4 cell counts below pretreatment levels. Of 11,714 patients at risk, 861 failed therapy.
The rapid expansion of the program and its success can be largely attributed to four factors, the researchers report. The leadership and advocacy provided by the Zambian government, demonstrated in its decision to eliminate patient fees, was a key factor in ensuring equal access. Second, although physician shortages prevented medical oversight at every facility, clinical officers and nurses at each site followed strict protocols for patient care. In addition, all patient data is entered into an electronic tracking and outcomes monitoring system, capturing data that assists in individual patient care and overall clinic management. Finally, large financial resources made available by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) contributed to the program’s success.
“Despite the burgeoning availability of ART, HIV prevention remains critical in Zambia, where each year an estimated 100,000 adults and children become infected and an additional 100,000 already infected individuals meet criteria for ART initiation,” the authors conclude. “We believe the early success of the Lusaka District ART Program calls for optimism. This experience demonstrates that it is possible, given proper resources and local government commitment, to treat many thousands of people in urban African settings.”
(JAMA. 2006;296:782-793. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This work was supported by a multicountry grant to the Elizabeth Glaser Pediatric AIDS Foundation from the U.S. Centers for Disease Control and Prevention. Additional investigator salary support is provided by National Institutes of Health grants and an Elizabeth Glaser Pediatric AIDS Foundation grant. 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. ET, Sunday, August 13, 2006
Media Advisory: To contact Susan Swindells, M.B.B.S., call Margaret Bumann at 402-559-4315.
STUDY SHOWS PROMISE FOR SIMPLIFIED TREATMENT OF HIV INFECTION
TORONTO—A preliminary study indicates that using a single boosted protease inhibitor instead of the standard regimen of 3 drugs for maintenance therapy may be an effective treatment for select patients with HIV infection, according to a study in the August 16 issue of JAMA, a theme issue on HIV/AIDS.
Susan Swindells, M.B.B.S., of the University of Nebraska Medical Center, Omaha, presented the findings of the study today at a JAMA media briefing at the International AIDS Conference in Toronto.
The long-term adverse effects, expense, and difficulty of sustained adherence to multidrug antiretroviral regimens have prompted studies of simpler therapies for human immunodeficiency virus type 1 (HIV-1) infection. Treatment cessation, intermittent therapy, and induction-maintenance (a few months of triple therapy followed by simplified therapy) regimens have been evaluated with mostly inferior results, according to background information in the article.
Dr. Swindells and colleagues conducted a study to determine whether a simplified maintenance therapy with the antiretroviral medication “boosted” atazanavir alone after virologic suppression (cessation of detectable HIV virus replication) would not markedly increase the risk of virologic failure. Protease inhibitors, such as atazanavir, are often combined with a small dose of ritonavir to increase blood levels – a phenomenon known as “boosting.” This regimen was selected because of low pill burden, once-daily dosing, safety, and unique resistance profile. The 24-week pilot study, conducted between Sept. 2004 and April 2006, included 36 HIV-infected adults with virologic suppression for 48 weeks or longer receiving their first protease inhibitor (PI)–based regimen. Participants switched PIs to atazanavir-ritonavir at entry and discontinued nucleoside analog reverse transcriptase inhibitors (NRTIs) after 6 weeks. Virologic failure was defined as two consecutive HIV-1 RNA measurements of 200 copies/mL or more. The final analysis included 34 patients.
Virologic success (absence of failure) through 24 weeks of simplified therapy occurred in 91 percent of patients (31 of 34). Three participants experienced virologic failure at 12, 14, and 20 weeks after simplification. Resistance testing at failure did not identify protease inhibitor resistance mutations. Atazanavir concentrations in the blood at failure were low or below detection in 2 of 3 participants experiencing failure, indicating these patients may not have taken the prescribed doses. There were no treatment discontinuations for adverse events after simplification and no significant changes in CD4 cell counts.
“In this pilot study, the data suggest that simplified maintenance therapy with atazanavir-ritonavir alone in patients who have never experienced treatment failure may be efficacious in maintaining HIV-1 RNA suppression below 200 copies/mL for 24 weeks after discontinuing NRTIs,” the authors write. “Maintenance therapy with a single boosted PI offers a treatment strategy with potentially less complexity, pill burden, long-term complications, and cost.”
The researchers add that although the findings are encouraging, caution regarding inferences is warranted due to study limitations such as the small number of participants in the study. “Larger, randomized trials comparing this approach with standard antiretroviral therapy are warranted.”
(JAMA. 2006;296:806-814. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This work was supported by NIH grants and a Virology Support Laboratory subcontract of the ACTG Central Group Grant. Industry support from Bristol-Myers Squibb and Abbott Laboratories was in the form of supplying study drugs and participation on the protocol team. 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. ET, Sunday, August 13, 2006
Media Advisory: To contact Scott M. Hammer, M.D., call Elizabeth Streich at 212-305-6535.
PANEL UPDATES GUIDELINES FOR TREATMENT OF ADULT HIV INFECTION
TORONTO—With antiretroviral therapy for adults with HIV infection continuing to evolve, the International AIDS Society – USA Panel has issued updated recommendations for the treatment of HIV, according to a report in the August 16 issue of JAMA, a theme issue on HIV/AIDS.
Scott M. Hammer, M.D., of the Columbia University College of Physicians and Surgeons, New York, presented the recommendations of the report today at a JAMA media briefing at the International AIDS Conference in Toronto.
In the last 25 years, acquired immunodeficiency syndrome (AIDS) has grown to pandemic proportions, resulting in 25 million deaths worldwide and an estimated 40 million persons living with human immunodeficiency virus (HIV), according to background information in the article. Guidelines for antiretroviral therapy are important for clinicians worldwide given the complexity of the field and the varied clinical situations in which these agents are used.
To provide physicians and other HIV clinicians with current recommendations for the use of antiretroviral therapy in HIV-infected adults in circumstances for which there is relatively unrestricted access to drugs and monitoring tools, the International AIDS Society–USA (IAS-USA) panel has updated its recommendations as warranted by new developments in the field. The 16-member noncompensated panel was appointed, based on expertise in HIV research and patient care internationally. Data published or presented at selected scientific conferences since mid-2004 through May 2006 were identified and reviewed by all members of the panel. The researchers identified 181 citations regarding antiretroviral agent trials that were considered potentially relevant.
New guidelines were drafted by a writing committee and reviewed by the entire panel. The recommendations of the panel are centered on 4 key issues: when to start antiretroviral therapy; what to start; when to change; and what to change.
The researchers write that initiation of antiretroviral therapy continues to be recommended in all symptomatic persons and in asymptomatic persons after the CD4 cell count falls below 350/μL and before it declines to 200/μL.
The panel members report that since the last edition of these guidelines, clinical trial and cohort studies have led to refinements in the choice of initial regimen. “The recommended initial regimen remains a combination of 2 nucleoside (or nucleotide) reverse transcriptase inhibitors (nRTIs) with either a nonnucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI) boosted with low-dose ritonavir. Given the high degree of comparability of the recommended components of these regimens in treatment-naive persons with drug-susceptible virus, the choice of regimen centers on acceptability; predicted tolerance; pill burden; comorbid conditions; short-term, mid-term, and long-term adverse event profiles; and successful alternatives should the initial regimen fail and drug resistance emerge. The successful outcomes of several ‘switch studies’ suggest that the initial choice of regimen does not preclude safely changing drugs once viral suppression is achieved.”
They add that adherence to antiretroviral therapy in the short-term and the long-term is crucial for treatment success and must be continually reinforced.
The researchers write that therapy should be changed when toxicity or intolerance mandate it or when treatment failure is documented. The virologic target for patients with treatment failure is now a plasma HIV-1 RNA level below 50 copies/mL, a goal that is now achievable in a substantial proportion of patients. Once antiretroviral therapy is initiated, plasma HIV-1 RNA level should be checked relatively frequently (e.g., every 4-8 weeks) until it reaches levels below the limits of detection of the assay and regularly thereafter (e.g., 3-4 times per year).
“In the nearly 2 decades since zidovudine was introduced, 21 additional agents in 5 drug classes have been approved; potent combination therapy has become a worldwide standard of care; morbidity and mortality in the developed world have been substantially reduced, and major antiretroviral rollouts have been initiated in the developing world. Balanced against this progress is the identification of major unpredicted toxic effects and recognition of the limitations that drug class cross-resistance place on alternate treatment regimens in the setting of treatment failure.”
“Given the rapid evolution of knowledge, clinicians are challenged to stay abreast of new information that can affect practice. Therapeutic choices rooted in the pathogenesis of HIV disease and individualization of therapy to maximize benefit are the principles that remain constant in a rapidly changing environment,” the researchers conclude.
(JAMA. 2006;296:827-843. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This work was funded by the International AIDS Society–USA. No private sector or government funding contributed to this effort; panel members are not compensated. 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 TREATMENT REGIMEN WITH FOUR DRUGS NO BETTER THAN THREE-DRUG REGIMEN
VIDEO:
B-ROLL
Jim at desk looking at pictures of various HIV medications/pills
AUDIO:
JIM SHEA (shay) HAS HAD HIV FOR ALMOST TWO DECADES. HE USED TO HAVE TO TAKE UP TO TWENTY PILLS A DAY.
VIDEO:
SOT/FULL
@ :07
Super: Jim Shea
Has HIV
Runs :10
AUDIO:
“It was three, four, five times a day that you’d have to remember to take meds, so in those days it was extremely difficult, it was a full-time job just to stay on the medications.”
VIDEO:
B-ROLL
Hand lining up three pills/3-drug combo on table
AUDIO:
TODAY, MEDICAL ADVANCES MEAN HIV PATIENTS GENERALLY START OUT TREATMENT TAKING THREE DRUGS.
VIDEO:
SOT/FULL
@ :22
Super: Roy Gulick, M.D., M.P.H.
Weill Medical College of Cornell University
Runs :14
AUDIO:
“Three drugs has been working well for people. People can suppress their viral load levels, that is the level of HIV in their blood. They can increase their T-cell counts, which is an important cell in the immune system. But the question is could we do better?”
VIDEO:
B-ROLL
Bite runs through his name
Exterior of Weill Medical College
Dr. Gulick and colleague looking at folder
3-drug combo pills
Hand lining up three pills/4-drug combo on table
GFX/JAMA COVER
AUDIO:
DR. ROY GULICK (GYOU-lik) OF WEILL (while) MEDICAL COLLEGE OF CORNELL UNIVERSITY IS PART OF A NATIONWIDE AIDS CLINICAL TRIAL GROUP FUNDED BY THE NATIONAL INSTITUTES OF HEALTH. THE RESEARCHERS COMPARED TREATMENT RESULTS IN PATIENTS WHO TOOK A THREE-DRUG REGIMEN TO THOSE WHO TOOK A FOUR-DRUG COMBINATION, IN THREE PILLS. THEIR FINDINGS APPEAR IN THIS SPECIAL HIV/AIDS THEME ISSUE OF JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
Roy Gulick, M.D., M.P.H.
Weill Medical College of Cornell University
Runs :11
AUDIO:
“The good news overall, was that all patients did well. In fact, more than 80 % of patients in the study suppressed their levels of HIV in the blood for as long as three years.”
VIDEO:
B-ROLL
Pan from 3-drug combo to 4-drug combo
AUDIO:
BUT WAS ‘MORE’ BETTER WHEN IT CAME TO TREATING HIV? NO, THE RESEARCHERS FOUND NO DIFFERENCE.
VIDEO:
SOT/FULL
Roy Gulick, M.D., M.P.H.
Weill Medical College of Cornell University
Runs :11
AUDIO:
“What we’ve concluded is that the 3-drug regimens that we have today for HIV are pretty good. That it’s actually hard to improve over the standard drugs that we have today.”
VIDEO:
B-ROLL
More Jim at desk looking at pills
AUDIO:
HIV PATIENT JIM SHEA SAYS THE STUDY FINDINGS ARE GREAT NEWS – THAT FEWER DRUGS MEAN FEWER SIDE EFFECTS AND MORE CONVENIENCE. BUT...
VIDEO:
SOT/FULL
Jim Shea
Has HIV
Runs :16
AUDIO:
“On the flipside of that however is the fact that the disease and the complications of the disease are being lost in the shuffle because people think oh, all I take to do is take two or three pills a day and I’m going to live this happy lifestyle and everything is going to be fine. And that’s just not true.”
VIDEO:
B-ROLL
Large number of HIV medication pills being poured on table
AUDIO:
HE SAYS THAT NO PILLS OR MEDICATIONS CAN LESSEN THE IMPORTANCE OF HIV PREVENTION. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
