Broad community support endorses the START study
4 May 2010. Related: News.
Over 140 community organisations sign letter to US guideline panel…
The following statement from a broad range of community organisations and advocates was released on 4 May 2010. It highlights the importance of the START trial to obtain the best quality of evidence to inform treatment decisions.
It also highlights that this is a safe study for all participants, and that it will answer important questions that will benefit hundreds of thousands of other HIV-positive people, in both rich and poor countries.
i-Base is a signatory to this letter and is proud to be supporting this important research.
Community statement on the START trial and the change in the US DHHS treatment guidelines
Introduction
The following statement was produced in response to a change in the US treatment guidelines in December 2009 that stated that antiretroviral (ARV) treatment should be universally started at any CD4 count below 500 cells/mm3.
The START study is currently enrolling patients to look at whether there is evidence to support such a recommendation. Currently no randomised trial has provided data on the advantages and risks of earlier treatment. This statement affirms both the importance of the START trial and the safety for people who enrol.
We believe that the priority for HIV-positive people is to have accurate, reliable data on both the risks and benefits of earlier treatment in order to base any decision for when to start treatment.
We fully support this study and invite other individuals and community organisations to endorse the importance of this research. Endorsements can be sent to endorsestart@gmail.com.
Statement
When to start antiretroviral treatment is one of the most important outstanding questions for people with HIV and their clinicians. A large clinical trial, Strategic Timing of Antiretroviral Treatment (START), has begun and will hopefully help answer this and other important questions. [1]
The START trial includes antiretroviral-naive HIV-positive people with CD4 counts greater than 500 cells/mm3. It is taking place at about 90 sites in nearly 30 countries. Participants are randomised to either receive antiretroviral treatment immediately or to defer treatment until their first CD4 count less than 350 cells/mm3 or they have clinical signs of AIDS. Eventually, START will recruit 4,000 people.
The deferred arm is the current standard of care throughout the world, with guidelines recommending treatment at a CD4 count of 350 cells/mm3. Clinical trials have demonstrated that once the CD4 count drops to below 350 cells/mm3, antiretroviral treatment should begin. [2, 3] However, the recent US guideline change requires a community response for US patients who still want to take part in this study.
On 1 December 2009, the United States (US) Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents were changed to recommend treatment for patients with CD4 counts between 350 and 500 cells/mm3. Of the more than two-thirds of Panel members who supported this recommendation, 55% recommended it strongly and 45% moderately. As explained in the guidelines, this recommendation is based solely on observational data primarily from two large cohorts known as ART CC and NA-ACCORD. As with all observational data the findings from these cohorts could be subject to confounding factors. [4]
Indeed, the ART CC investigators have stated, “We are concerned that some may interpret the new [US] recommendations as implying that the deferral group of this trial is no longer ethical. Such an interpretation would endanger the future of the trial in the [US].” [5]
They further state, “We … do not believe that there is convincing evidence to conclude that deferral of initiation of ART to a CD4 count of [350 cells/mm3] causes net harm, particularly in terms of mortality, compared with starting at any higher level. We strongly support continued enrolment into START. Large randomised studies represent the only means of eventually obtaining the definitive result we need to properly inform future patient care.
We agree with the ART CC investigators. The available evidence is insufficient to determine if the adherence challenges and long-term side-effects of early antiretroviral treatment are outweighed by reduced risk of illness conferred by these medicines. Only a randomised controlled trial, such as START, can determine this.
The NA-ACCORD data is also challenged by the researchers who orginally developed the new statistical methodology. They were not convinced that the application thereof was without problems. [6]
We too are concerned that the new US recommendation:
(1) raises theoretical concerns about continued enrolment of patients in the US, a substantial source of patients, and
(2) is based on poor evidence and therefore might not be in the best interests of patients.
We also have further concerns that:
(3) previous recommendations to use earlier treatment failed to recognise the negative impact of resistance and side effects, and
(4) a minority of individuals have normal CD4 counts between 350-500 and would therefore be using treatment prior to any significant immune damage.
We support research findings that the absolute risk of HIV-related complications remains very low at a CD4 count 350–500 and that individuals enrolled in START will be carefully monitored and access treatment if their health circumstances change.
We also support the unique importance of sub-studies in START.
These studies have the potential to answer important questions relating to the impact of HIV, treatment and ageing on neurology and mental health, bone health, heart disease, lung disease and behaviour risk.
We support the START investigators, community advocates and HIV-positive people interested in this dynamic research which will help close the essential gap in our current knowledge on the safety and risks of earlier treatment.
Signed:
(Members of the INSIGHT Community Advisory Board in surname alphabetical order)
Peer Aagaard, Denmark
Simon Collins, London
Nathan Geffen, South Africa
Joseph Hall, USA
David H. Haerry, Switzerland
Michael Meulbroek, Spain
David Munroe, USA
Dwight Peavy, USA
Claire Rappoport, USA
Siegfried Schwarze, Germany
Mirta Valdez, Argentina
Jo Watson, Australia
The statement has also been sent to the chairs of the United States Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents.
Community Statement and sign-ons PDF
For media comment, please contact:
Simon Collins, (UK) HIV i-Base, +44 (0) 20 7407 8488
Nathan Geffen, (South Africa) Treatment Action Campaign, +27 (0) 84 542 6322
David Munroe (USA)
Organizational Endorsers
Asociación de vih/sida (ADHARA), Diego Garcia
Acadiana Cares, Marcia Dorsey, Lafayette, LA, USA
ACT UP PHILAELPHA, Jose de Marco, Philadelphia, PA, USA
Adhara-Sevilla, Juan Antonio Reina, Sevilla, Spain
AIDS Action Baltimore, Lynda Dee, Baltimore, MD, USA
AIDS Action Committee of MA, Denise McWilliams, Boston, MA, USA
AIDS Action Council of the ACT, Andrew Burry, Canberra, ACT, Australia
AIDS Alabama, Kathie Hiers, Birmingham, AL, USA
AIDS Alliance for Faith and Health, Dawn Womack, Reverend Jamil Willis, Atlanta, GA, USA
AIDS Care Ocean State, JoAnne Ash, Pamerla Dee, Daniel Zariczny, Providence, RI, USA
AIDS Care, Jackie Dozier, Rochestser, NY, USA
AIDS Community Research Consortium, Megan O’Day, Redwood City, CA, USA
AIDS Community Research Initiative of America, Daniel Tietz, New York, NY, USA
AIDS Education Global Information System, Sister Mary Elizabeth, San Juan Capistrano, CA, USA
AIDS Global Action, Blair Wynkoop, Washington, DC, USA
AIDS Legal Council of Chicago, Ann Fisher, Chicago, IL, USA
AIDS Project Los Angeles, Philip Curtis, Los Angeles, CA, USA
AIDS Project of the East Bay, Damon Powell, Oakland, CA, USA
AIDS Resource Council, Inc., Frank Tant, Rome, GA, USA
AIDS Services for the Monadnock region, Arnold Grandell, Gilsum , NH, USA
AIDS Services of Dallas, Don Maison, Dallas, TX, USA
AIDS Treatment Activist Coalition, Matt Sharp, Brisbane, CA, USA
AIDS/HIV Health Alternatives, Terry Grand, North Hollywood, CA, USA
AIDSmeds.com, Tim Horn, New York, NY, USA
Allies Linked for the Prevention of HIV and AIDS (a.l.p.h.a.), Duane Quintana, Boise, ID, USA
amfAR, The Foundation for AIDS Research , Chris Collins, Washington, DC, USA
Argus Community, Terese Smauldon, Bronx, NY, USA
Australian Federation of AIDS Organisations (AFAO), Don Baxter, Sydney, New South Wales, Australia
AVAC, Kevin Fisher, Mitchell Warren, New York, NY, USA
Beacons of H.O.P.E., Dean Page, West Covina, CA, USA
Black AIDS Memphis, Ernest Donelson, Memphis, TN, USA
Boston Living Center, Wayne Callahan, Mattapan, MA, USA
Care Directions, Jose Alfredo Alvarez, Phoenix, AZ, USA
Center for AIDS, Paul Simmons, Houston, TX, USA
Central City AIDS Network, Johnny Fambro, Macon, GA, USA
CHAIN, Virginia Tonelli, Des Moines, IA, USA
Chicago Womens AIDS Project, Zoe Lehman, Chicago, IL, USA
Choose Life, Patson Phiri, Pretoria, Gauteng, South Africa
Christie’s Place, Irene Milton, San Diego, CA, USA
Community Partners CAB Member, Hamilton Richardson, Baltimore, MD, USA
Common Ground – the Westside HIV Community Center, Jeffrey Goodman, Santa Monica, CA, USA
Community HIV/AIDS Mobilization Project (CHAMP), Julie Davids, Walton Senterfitt, Cranston, RI, USA
Community Research Initiative, Anthony Carpinelli, Boston, MA, USA
Coordinadora de asociaciones de VIH de la Comunidad Valenciana, Begoña Bautista Casanova, Spain
Denver Health, Joshua Blum, Denver, CO, USA
Desert AIDS Project, Peter DeMartino, Palm Springs, CA, USA
Duke University AIDS Research and Treatment Community Advisory Board, Anthony Wright, Charlotte, NC, USA
Dunshee House / SASG, Jake Ketchum, Dale Rogers, Seattle, WA, USA
E.C.H.O. Resource Center, Ann Dixon, North Little Rock, AR, USA
European AIDS Treatment Group, Haerry David Hans-Ulrich
European Community Advisory Board, Wim Vandevelde
Foundation for Integrative AIDS Research (FIAR), George Carter, Brooklyn, NY, USA
Gay City News, Doug Ireland, New York, NY, USA
Gay Men’s Health Crisis / Client Advisory Board, Joseph Arsenault, Bronx, NY, USA
Global Network of People Living with HIV/AIDS (GNP+/NA), Dr. Frenk Guni, Silver Spring, MD, USA
Grupo de Trabajo sobre Tratamientos del VIH (gTt), Juanse Hernández, Barcelona, Cataluña, Spain
Grupo Português de Activistas sobre Tratamentos de VIH/SIDA (GAT), Wim Vandevelde, Portugal
Harm Reduction Institute, Larry Pasco, Indianapolis, IN, USA
Health Equities institute, San Francisco State University, Nicholas J. Alvarado, San Francisco, CA, USA
Health GAP (Global Access Project), Paul Davis, Nairobi, Kenya
HealthHIV, Brian Hujdich, Washington, DC, USA
Hepatitis, AIDS, Research Trust, James Hoyt, Florence, CO, USA
HIV Dental Alliance, David Reznik, Atlanta, GA, USA
Hiv-Danmark, Bent Hansen, Copenhagen, Denmark
HIV/AIDS Advocacy Network, Randal Lucero, Albuquerque, NM, USA
HIV/AIDS Law Project, Karen Stuart, Phoenix, AZ, USA
HIV/AIDS Services for African Americans in Alaska, Hugh Brown III, Anchorage, AK, USA
HIV Denmark, Henrik Arildsen
HIV Europe, Henrik Arildsen
HIV i-Base, Polly Clayden, UK
HIVictorious, Inc., Bob Bowers, Madison, WI, USA
Holley Gerald Foundation, Calvin Gerald, Washington, DC, USA
Housing Works, Christine Campbell, Washington, DC, USA
Illinois Alliance for Sound AIDS Policy, J Michael Polasek, Iuka, IL, USA
International AIDS Empowerment, Lorenzo Sias Jr., El Paso, TX, USA
International Treatment Preparedness Coalition (ITPC), Sarah Zaidi
International Community of Women Living with HIV and AIDS-North American Region (ICW-NA), Beri Hull, Washington, DC, USA
International Foundation for Alternative Research in AIDS, Fred Schaich, Portland, OR, USA
Italian League For Fighting Aids – LILA, Alessandra Cerioli, Torino , Italy
Jo-Ray House Inc, Ida Bythersmith, Chicago, IL, USA
LaGender Inc., Dee Dee Chamblee, Atlanta, GA, USA
Lesbian, Gay, Transexual and Bisexual Spanish Federation (FELGTB),Rubén Sancho
LifeLinc, Wanda Commander, Baltimore, MD, USA
LIGHT Health & Wellness Comprehensive Services, Inc., Debbie Rock, Baltimore, MD, USA
Lion Heart Network Advocates, A. Alberto Abello, San Francisco, CA, USA
Lower East Side Harm Reduction Center, Rev Raquel Algarin, New York, NY, USA
Madrid LGTB Group (COGAM), Rafael Torres Barrio, Spain
Maine General Health Associates – The Horizon Program, Peter Schlosser, Gardiner, ME, USA
McGregor Clinic, Inc., Sharon Murphy, Fort Myers, FL, USA
Metropolitan Community Health Services, Elizabeth Shepherd, Washington, NC, USA
MiamiValleyPoz4Poz, Keith Matthews, Dayton, OH, USA
NAM, Keith Alcorn, London, UK
Nashville CARES, Joseph Interrante, Nashville, TN, USA
National AIDS Housing Coalition, Lola Adele-Oso, Washington, DC, USA
National Association of People Living With HIV/AIDS Australia, Robert Mitchell, Newtown, NSW, Australia
National Coalition for LGBT Health, Kellan Baker, Washington, DC, USA
National Pediatric AIDS Network, Gary Gale, Boulder, CO, USA
New Destiny Recovery Ministry, Rrowena Simmons, Baltimore, MD, USA
New York Law School, Arthur Leonard, New York, NY, USA
North American Old Catholic Church, Archbishop Michael Seneco, Washington, DC, USA
Northwestern University, Eric Christoff, Chicago, IL, USA
NW Florida AIDS/HIV Consortium Area (NOFLAC), James Talley, Pensacola, FL, USA
OCASET, Jose Diaz, San Juan, PR, USA
OptimalTrials, James Karin, Gaithersburg, MD, USA
Outer Cape Dental Center, Timothy Martinez, South Wellfleet, MA, USA
Pacientes de Sida pro Politica Sana, Anselmo Fonseca, SJ, PR, USA
PALSS, Carmen Julious, Columbia, SC, USA
PH RockWood.com, Dr. Roscoe M Moore Jr., Rockville, MD, USA
Philadelphia FIGHT, Teresa Sullivan, Philadelphia, PA, USA
Positive East Tennesseans, Larry Frampton, Knoxville, TN, USA
Positive Life NSW, Rob Lake, Darlinghurst, Sydney, NSW, Australia
Positive Women’s Network/Oakland/Local, Loren Jones, Berkeley, CA, USA
Positively Positive, Bradford McIntyre, Vancouver, BC, Canada
POZ Charlottte.org, Clinton Woods, charlotte, NC, USA
Progressive Health partners International, Dr. Frenk Guni, Frederick, MD, USA
Projecte dels NOMS-Hispanosida, Michael Meulbrook
Public Personalities Against AIDS Trust, Tendayi Westerhof, Harare, Zimbabwe
PWA Coalition Colorado, Chad Kenney, Denver, CO, USA
Research + Education Group INSIGHT Wash DC ICC CCG Member, Dale Sattergren, Portland, OR, USA
Resource Center Dallas, Bret Camp, Dallas, TX, USA
Roper St. Francis Ryan White Program, Ashley Redmond, Charleston, SC, USA
Ruth M. Rothstein CORE Center, Peter McLoyd, Chicago, IL, USA
Ryan White Part-C, George Martinez-Alicea, Guayama, PR, USA
Shanti, Derrick Mapp, San Francisco, CA, USA
SisterLove, Inc., Lisa Diane White, Atlanta, GA, USA
SomeoneCares of Atlanta, Laurency Gaston, Smyrna, GA, USA
South Carolina Campaign to End AIDS (SC-C2EA), Karen Bates, Columbia, SC, USA
Spanish Community Advisory Board (FEAT), Diego Garcia, Spain
Spanish Federation of AIDS NGOs (CESIDA), Santiago Pérez Avilés,
Status C Unknown, Shari Foster, Medford, NY, USA
SUNY Downstate Medical Center, Michael Carden, Brooklyn, NY, USA
Tapestry Health, Leslie Laurie, Florence, MA, USA
Terrence Higgins Trust, Paul Ward, London, UK
Test Positive Aware Network, Jeff Berry, Chicago, IL, USA
The Afiya Center HIV Prevention & Sexual Reproductive Justice, Marsha Jones, Dallas, TX, USA
The AIDS Institute, David Miller, Carl Schmid, Washington, DC, USA
The Center for HIV Law and Policy, Catherine Hanssens, New York, NY, USA
The Montefiore Women’s Center, Anitra Pivnick, Bronx, NY, USA
2 God B The Glory, Women Supportive Housing Program, Rowena Simmons, Baltimore, MD, USA
Tom Waddell Clinic, David Glennon, San Francisco, CA, USA
Transdiaspora Network, Inc., Ariel Rojas, Brooklyn, NY, USA
Treatment Action Campaign, Vuyiseka Dubula, South Africa
Treatment Action Group, Lei Chou, Mark Harrington, Richard Jefferys, New York, NY, USA
Treatment Education Network, Michael Dorosh, Denver, CO, USA
Triad Health Project, Melissa Moorehead, Greensboro, NC, USA
TVEP, Tian Johnson, Johannesburg, South Africa
Twin States Network, Jo Schneiderman, Guilford, VT, USA
U.S. Positive Women’s Network (PWN), Naina Khanna, Berkeley, CA, USA
UDCAS, Jose Diaz, San Juan, PR, USA
UKCAB, Michael Marr, London, UK
University of Minnesota, Alicen Spaulding, Minneapolis, MN, USA
Virginia Commonwealth University, Joy Zeh, Richmond, VA, USA
Wayne State University CAB, Janyce Cook, Detroit, MI, USA
West Ohio UMC Conference AIDS Ministry, Lonny LeFever, Conover, OH, USA
Zephyr L.T.N.P. Foundation, Inc., Loreen Willenberg, Sacramento, CA, USA
Individual Endorsers
Rafael Abadia, Palm Beach Gardens, FL, USA
Scott Amundsen, Oneonta, NY, USA
Jared Baeten, Seattle, WA, USA
Sean Barry, Brooklyn, NY, USA
Lincoln Bartholomew, New York, NY, USA
Amanda Beck-Myers, Edgewood, KY, USA
Jeanne Bergman, New York, NY, USA
Richard Berkowitz, New York, NY, USA
David Brakebill, Key West, FL, USA
Matthew Bray, Brooklyn, NY, USA
Paul Brodish, Carrboro, NC, USA
Lara Brooks, Chicago, IL, USA
Raymond Brooks, Manchester, NH, USA
Keith Burress, Malvern, PA, USA
Rob Camp, Barcelona, Catalunya, Spain
Tom Cassady, Fort Worth, TX, USA
Peter Cecil, Rockdale, IL, USA
Bryan Cole Smith, Wenonah, NJ, USA
Regina Cossey, Gary, IN, USA
Eduviges Cuello, Santo Domingo, Distrito Nacional, Dominican Republic
Vince Cukrov, San Simeon, CA, USA
Mitch DeBoer, Indianapolis, IN, USA
Randolph Decker, Tucson, AZ, USA
Nikos Dedes, Greece
Thomas DeLorenzo, Los Angeles, CA, USA
Cheryl Derocher, Miamisburg, OH, USA
Jose Diaz, Puerto Rico, USA
Ben W. Dunn III, New York, NY, USA
Jim Eigo, New York, NY, USA
William Ellington, Detroit, MI, USA
Marcia Ellis, Alexandria, VA, USA
Shira EtShalom, Philadelphia, PA, USA
David Evans, Los Angeles, CA, USA
Marta Feldmesser, Bronx, NY, USA
Robert Ferguson, Ann Arbor, MI, USA
Phillip Fielding, Ridley Park, PA, USA
Heather Fisch, Providence, RI, USA
Anna Forbes, Kensington, MD, USA
Kenneth Fornataro, New York, NY, USA
Elana Galante, San Francisco, CA, USA
Gregg Gonsalves, New Haven, NY, USA
Jeffrey Goodman, Santa Monica, CA, USA
Deirdre Grant, New York, NY, USA
Claudia Grayson, Sacramento, CA, USA
Hamilton Gregory, Ardmore, OK, USA
Kathlee Griffith, Peoria, IL, USA
Johnny Guaylupo, New York, NY, USA
Andres Guerrero, Denver, CA, USA
Anthony Guillaume, Queens Village, NY, USA
Lyn Hackenberg, Ambler, PA, USA
Bridget Haire, Sydney, NSW, Australia
Mark Hall, Maryville, TN, USA
Graham Harriman, New York, NY, USA
Phillip Herrington, Pittsburgh, PA, USA
Steve Hoke, Vero Beach, FL, USA
Lital Hollander, Rovello Porro, CO, Italy
Trevor Hoppe, Ann Arbor, MI, USA
Bob Huff, San Diego, CA, USA
Ashley Hunt, Van Nuys, CA, USA
Howard Joyce, Detroit, MI, USA
Dr. Lynne Joyrich, Warwick, RI, USA
Sharon Kathrens, Kansas City, MO, USA
Ingrid Kloet, Rio Rancho, NM, USA
Robert Krier, Anchorage, AK, USA
Vickie Lynn, Tampa, FL, USA
Peggi Marini, Boston, MA, USA
David P. Martin, New York, NY, USA
Sylvia Mata, Fullerton, CA, USA
Jeff Mathews, Albuquerque, NM, USA
Shirley Mathis, Dallas, TX, USA
Linda McFarlane, Los Angeles, CA, USA
Jacqueline Melvin, Durham, NC, USA
Terrell Moody, Alma, GA, USA
Clyde “RAY” Moore, Granbury, TX, USA
Timothy Moore, Santa Cruz, CA, USA
Bernardino Mosquera, Miami Beach, FL, USA
Joshua O’Neal, Seattle, WA, USA
William Palmer, Baltimore, MD, USA
Earl Plante, Hayward, CA, USA
Niles Puckett, Jackson, MS, USA
Eliza Quill, Augusta, ME, USA
Kevin Quinn, Boston, MA, USA
Gary Richardson, Painesville, OH, USA
Margy Robinson, Portland, OR, USA
Jorge Romero, Vauxhall, NJ, USA
Douglas Rose, Abingdon, MD, USA
Frieda S, Jacksonville, FL, USA
David Sackett, Baltimore, MD, USA
Rickey Sain Sr., Oak Park, IL, USA
Nicole Seguin, Detroit, MI, USA
Matt Sharp, San Francisco, CA, USA
Sandy Sheble-Hall, Dover, MA, USA
Steve Shoptaw, Los Angeles, CA, USA
Patricia E. Sloan, Chicago, IL, USA
Joseph Sonnabend, New York, NY, USA
Val Sowell, Philadelphia, PA, USA
Jean Stanford, Boston, MA, USA
John Stimatz, Seattle, WA, USA
Autrey Stinett, Glorieta, NM, USA
Sean Strub, Founder, POZ Magazine, New York, NY, USA
Scott Terry, Albuquerque, NM, USA
Christopher Thomas, San Diego, CA, USA
Hale Thompson, Minneapolis, MN, USA
Virginia Tonelli, Des Moines, IA, USA
William Torres, Vega Baja, PR, USA
Robert Toth, Cleveland, Oh, USA
John Weatherman, San Francisco, CA, USA
Julene Weaver, Seattle, WA, USA
Matthias Wienold, Hanover, Germany
Snow William, San Francisco, CA, USA
Bonnie Williams, Saratoga, CA, USA
Seanna Williams, Orem, UT, USA
William Wilson, Chicago, IL, USA
Joe Wright, Cambridge, MA, USA
Louis Zimmerman, Aurora, CO, USA
References
1. Strategic Timing of Antiretroviral Treatment (START).
http://clinicaltrials.gov/ct2/show/NCT00867048
http://insight.ccbr.umn.edu/start/
2. Severe P et al. 2009. A randomized clinical trial of early versus standard antiretroviral therapy for HIV-infected patients with a CD4 T cell count of 200-350 cells/ml (CIPRAHT001). Paper presented at: 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; Sep 12-15; San Francisco, CA. Abstract H1230c.
3. Emery S et al. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study. J Infect Dis. 2008;197(8):1133-1144.
4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. December 1, 2009; 1-161.
http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf
5. Phillips et al. Early initiation of treatment for HIV infection. The Lancet, Volume 375, Issue 9715, Page 639, 20 February 2010. doi:10.1016/S0140-6736(10) 60269-3.
6. Hernán M, Robins J, Early versus Deferred Antiretroviral Therapy for HIV, Correspondence, N Engl J Med 2009; 361:822-824.