title: Management of HIV infection in treatment-naive patients: a review of the most current recommendations.
abstract: OBJECTIVE
  The most current guidelines issued by the Department of Health and Human Services (DHHS) on the management of human immunodeficiency virus (HIV) infection in treatment-naive patients are reviewed.
  
  
  CONCLUSIONS
  Treatment guidelines are updated frequently because of the emergence of data demonstrating the risks and benefits of antiretroviral therapy. The DHHS guidelines strongly recommend initiating therapy in patients with certain conditions regardless of CD4 cell count and in patients with CD4 cell counts of <350 cells/mm(3). Although supporting data are less definitive, treatment is also recommended for patients with CD4 cell counts of 350-500 cells/mm(3). Treatment for patients with CD4 cell counts of >500 cells/mm(3) is controversial. Although cumulative observational data and biological evidence support treatment at higher CD4 cell counts, randomized controlled trial data to support this are not available, and the risk of antiretroviral toxicities, resistance, non-adherence, and cost should be considered in individual patients. The preferred regimens have been consolidated to four options, including a dual-nucleoside reverse transcriptase inhibitor backbone (tenofovir plus emtricitabine) with a nonnucleoside reverse transcriptase inhibitor (efavirenz), a ritonavir-boosted protease inhibitor (atazanavir plus ritonavir or darunavir plus ritonavir), or an integrase strand-transfer inhibitor (raltegravir). Regimens are classified as alternative or acceptable when they have potential safety or efficacy concerns, have higher pill burdens, or require more-frequent administration compared with preferred regimens.
  
  
  CONCLUSIONS
  The DHHS 2011 guidelines advocate earlier antiretroviral therapy initiation than recommended in recent years, and preferred regimens have been refined to maximize efficacy, safety, and quality of life for treatment-naive HIV-infected patients.
authors: Office of Safety and Epidemiology, Food and Drug Administration, Silver Spring, MD. sarita.boyd@fda.hhs.gov
authors: Sarita D
authors: SD
authors: Boyd
references: N Engl J Med. 2002 Jun 27;346(26):2039-46
references: 12087139
references: N Engl J Med. 2009 Apr 30;360(18):1815-26
references: 19339714
references: J Infect Dis. 2005 Feb 1;191(3):339-47
references: 15633092
references: AIDS. 2008 Oct 1;22(15):1979-91
references: 18784461
references: J Am Soc Nephrol. 2005 Aug;16(8):2412-20
references: 15987747
references: Ann Intern Med. 2007 Apr 17;146(8):564-73
references: 17438315
references: J Clin Invest. 2005 Nov;115(11):3250-5
references: 16276421
references: J Acquir Immune Defic Syndr. 2002 Mar 1;29(3):275-83
references: 11873077
references: J Acquir Immune Defic Syndr. 2009 Apr 1;50(4):367-74
references: 19214123
references: AIDS. 2007 May 31;21(9):1185-97
references: 17502729
references: J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):74-8
references: 17971715
references: J Infect Dis. 2010 Mar 15;201(6):803-13
references: 20151839
references: Clin Infect Dis. 2010 May 15;50(10):1387-96
references: 20380565
references: AIDS. 2009 Aug 24;23(13):1679-88
references: 19487905
references: J Viral Hepat. 2009 Jul;16(7):471-8
references: 19457140
references: Lancet. 2006 Aug 5;368(9534):476-82
references: 16890834
references: Lancet. 2002 Dec 14;360(9349):1921-6
references: 12493258
references: AIDS. 2007 May 31;21(9):1215-8
references: 17502736
references: MMWR Recomm Rep. 1992 Dec 18;41(RR-17):1-19
references: 1361652
references: J Infect Dis. 2008 Apr 15;197(8):1133-44
references: 18476292
references: Lancet. 2008 Aug 23;372(9639):646-55
references: 18722869
references: AIDS. 2008 Jul 31;22(12):1389-97
references: 18614861
references: AIDS. 2009 Jul 31;23(12):1547-56
references: 19542866
references: J Acquir Immune Defic Syndr. 2006 Mar;41(3):385-92
references: 16540942
references: J Acquir Immune Defic Syndr. 2009 May 1;51(1):20-8
references: 19282778
references: AIDS. 2008 Jul 31;22(12):1522-3
references: 18614879
references: Lancet. 2009 Sep 5;374(9692):796-806
references: 19647866
references: JAMA. 2004 Jul 14;292(2):191-201
references: 15249568
references: Ann Neurol. 2008 Feb;63(2):213-21
references: 17894380
references: N Engl J Med. 2009 Dec 3;361(23):2230-40
references: 19952143
references: Lancet Oncol. 2009 Dec;10(12):1152-9
references: 19818686
references: N Engl J Med. 2006 Nov 30;355(22):2283-96
references: 17135583
references: HIV Med. 2008 Jan;9(1):14-8
references: 18199168
references: Nat Med. 2003 Jun;9(6):727-8
references: 12754504
references: AIDS. 2010 Jan 28;24(3):F1-9
references: 20009917
references: J Acquir Immune Defic Syndr. 2007 Feb 1;44(2):179-87
references: 17075385
references: Nephrol Dial Transplant. 2006 Oct;21(10):2809-13
references: 16864598
references: MMWR Morb Mortal Wkly Rep. 2006 Jun 2;55(21):592-7
references: 16741495
references: Lancet. 2008 Apr 26;371(9622):1417-26
references: 18387667
references: Nature. 1997 May 8;387(6629):188-91
references: 9144290
references: Lancet. 2009 Apr 18;373(9672):1352-63
references: 19361855
references: N Engl J Med. 2000 Mar 30;342(13):921-9
references: 10738050
references: AIDS. 2002 Dec 6;16(18):2455-9
references: 12461420
references: Lancet. 2004 Apr 17;363(9417):1253-63
references: 15094269
references: N Engl J Med. 2008 May 15;358(20):2095-106
references: 18480202
references: AIDS. 2008 Oct 18;22(16):2143-53
references: 18832878
references: AIDS. 2008 Feb 19;22(4):481-7
references: 18301060
references: J Acquir Immune Defic Syndr. 2008 Dec 15;49(5):499-506
references: 18989230
references: AIDS. 2008 Sep 12;22(14):F17-24
references: 18753925
references: Int J STD AIDS. 2009 Apr;20(4):276-7
references: 19304978
references: HIV Med. 2009 Sep;10(8):482-7
references: 19459988
references: Clin Infect Dis. 2009 Nov 15;49(10):1591-601
references: 19842973
references: Ann Intern Med. 2003 Apr 15;138(8):620-6
references: 12693883