Management of HIV infection in treatment-naive patients: A review of the most current recommendations

American Journal of Health-System Pharmacy

Volumn 68, Issue 11, 2011, Pages 991-1001

  Boyd, Sarita D ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Antiretroviral agents; Atazanavir; Combined therapy; Darunavir; Department of Health and Human Services; Dosage; Efavirenz; Emtricitabine; HIV infections; Mechanism of action; Protocols; Quality of life; Raltegravir; Ritonavir; Tenofovir; Toxicity

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ATAZANAVIR; ATAZANAVIR PLUS RITONAVIR; DARUNAVIR; DARUNAVIR PLUS RITONAVIR; DIDANOSINE; EFAVIRENZ; EMTRICITABINE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; FOSAMPRENAVIR; FOSAMPRENAVIR PLUS RITONAVIR; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR PLUS RITONAVIR; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; PROTEINASE INHIBITOR; RALTEGRAVIR; RITONAVIR; RITONAVIR PLUS SAQUINAVIR; STAVUDINE; TENOFOVIR;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ANTIVIRAL THERAPY; CD4 LYMPHOCYTE COUNT; CENTRAL NERVOUS SYSTEM DISEASE; CHOLESTEROL BLOOD LEVEL; COMBINATION CHEMOTHERAPY; DIARRHEA; DIZZINESS; DRUG COST; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSLIPIDEMIA; GASTROINTESTINAL SYMPTOM; GLOMERULUS FILTRATION RATE; HEPATITIS B; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERBILIRUBINEMIA; INSULIN RESISTANCE; KIDNEY DYSFUNCTION; KIDNEY TUBULE NECROSIS; LIVER TOXICITY; NEPHROLITHIASIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; TRIACYLGLYCEROL BLOOD LEVEL; VIRUS LOAD; VIVID DREAM;

EID: 79958286997     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp100156     Document Type: Review

References (76)

1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, January 10, 2011. http://aidsinfo.nih.gov/ ContentFiles/AdultandAdolescentGL.pdf (accessed 2011 Jan 10).
2. Kitahata MM, Gange SJ, Abraham AG et al. Effect of early versus deferred antiretroviral therapy for HIV on survival. N Engl J Med. 2009; 360:1815-26.
3. Guiguet M, Boue F, Cadranel J et al. Effect of immunodeficiency, HIV viral load, and antiretroviral therapy on the risk of individual malignancies (FHDH-ANRS CO4): a prospective cohort study. Lancet Oncol. 2009; 10:1152-9.
4. Antiretroviral Therapy Cohort Collaboration. Causes of death in HIV-1-infected patients treated with antiretroviral therapy, 1996-2006: collaborative analysis of 13 HIV cohort studies. Clin Infect Dis. 2010; 50:1387-96.
5. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. http://aidsinfo.nih.gov/Content Files/PerinatalGL.pdf (accessed 2010 May 28).
6. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the use of anti-retroviral agents in pediatric HIV infection. http://aidsinfo.nih.gov/Content Files/PediatricGuidelines.pdf (accessed 2011 Jan 5).
7. Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Recomm Rep. 1992; 41(RR-17):1-19.
8. Perelson AS, Essunger P, Cao Y et al. Decay characteristics of HIV-1-infected compartments during combination therapy. Nature. 1997; 387:188-91. (Pubitemid 27209434)
9. Siliciano JD, Kajdas J, Finzi D et al. Long-term follow-up studies confirm the stability of the latent reservoir for HIV-1 in resting CD4+ T cells. Nat Med. 2003; 9:727-8. (Pubitemid 36749221)
10. Chun TW, Nickle DC, Justement JS et al. HIV-infected individuals receiving effective antiviral therapy for extended periods of time continually replenish their viral reservoir. J Clin Invest. 2005; 115:3250-5. (Pubitemid 41567589)
11. Phair JP, Mellors JW, Detels R et al. Virologic and immunologic values allowing safe deferral of antiretroviral therapy. AIDS. 2002; 16:2455-9. (Pubitemid 35476884)
12. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, December 1, 2007. http://aidsinfo.nih.gov/ Guidelines/ArchivedGuidelines.aspx? MenuItem=Guidelines&Search=Off& GuidelineID=18&ClassID=6 (accessed 2010 May 28).
13. May M, Sterne JA, Sabin C et al. Prognosis of HIV-1-infected patients up to 5 years after initiation of HAART: collaborative analysis of prospective studies. AIDS. 2007; 21:1185-97. (Pubitemid 46763289)
14. Emery S, Neuhaus JA, Phillips AN 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; 197:1133-44. (Pubitemid 351590049)
15. Lau B, Gange SJ, Moore RD. Risk of non-AIDS-related mortality may exceed risk of AIDS-related mortality among individuals enrolling into care with CD4+ counts greater than 200 cells/mm3. J Acquir Immune Defic Syndr. 2007; 44: 179-87. (Pubitemid 46292221)
16. Palella FJ Jr, Deloria-Knoll M, Chmiel JS et al. Survival benefit of initiating antiretroviral therapy in HIV-infected persons in different CD4+ cell strata. Ann Intern Med. 2003; 138:620-6.
17. Severe P, Juste MA, Ambroise A et al. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. N Engl J Med. 2010; 363:257-65.
18. Sterne JA, May M, Costagliola D et al. Timing of initiation of antiretroviral therapy in AIDS-free HIV-1-infected patients: a collaborative analysis of 18 HIV cohort studies. Lancet. 2009; 373:1352- 63.
19. Quinn TC, Wawer MJ, Sewankambo N et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. N Engl J Med. 2000; 342:921-9. (Pubitemid 30177052)
20. Tovanabutra S, Robison V, Wongtrakul J et al. Male viral load and heterosexual transmission of HIV-1 subtype E in northern Thailand. J Acquir Immune Defic Syndr. 2002; 29:275-83. (Pubitemid 34208536)
21. INSIGHT START 001 (Strategic Timing of AntiRetroviral Treatment). Protocol synopsis. http://insight.ccbr.umn.edu/ start/ (accessed 2010 Mar 15).
22. Atta MG, Gallant JE, Rahman MH et al. Antiretroviral therapy in the treatment of HIV-associated nephropathy. Nephrol Dial Transplant. 2006; 21:2809-13. (Pubitemid 44542235)
23. Schwartz EJ, Szczech LA, Ross MJ et al. Highly active antiretroviral therapy and the epidemic of HIV+ end-stage renal disease. J Am Soc Nephrol. 2005; 16:2412- 20.
24. Kalayjian RC, Franceschini N, Gupta SK et al. Suppression of HIV-1 replication by antiretroviral therapy improves renal function in persons with low CD4 cell counts and chronic kidney disease. AIDS. 2008; 22:481-7. (Pubitemid 351317289)
25. Thein HH, Yi Q, Dore GJ et al. Natural history of hepatitis C virus infection in HIV-infected individuals and the impact of HIV in the era of highly active antiretroviral therapy: a meta-analysis. AIDS. 2008; 22:1979-91.
26. Thio CL, Seaberg EC, Skolasky R Jr et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet. 2002; 360:1921-6. (Pubitemid 35472132)
27. Monforte A, Abrams D, Pradier C et al. HIV-induced immunodeficiency and mortality from AIDS-defining and non- AIDS-defining malignancies. AIDS. 2008; 22:2143-53.
28. Bhaskaran K, Mussini C, Antinori A et al. Changes in the incidence and predictors of human immunodeficiency virusassociated dementia in the era of highly active antiretroviral therapy. Ann Neurol. 2008; 63:213-21. (Pubitemid 351355300)
29. El-Sadr WM, Lundgren JD, Neaton JD et al. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006; 355:2283-96. (Pubitemid 44837777)
30. Ross AC, Armentrout R, O'Riordan MA et al. Endothelial activation markers are linked to HIV status and are independent of antiretroviral therapy and lipoatrophy. J Acquir Immune Defic Syndr. 2008; 49:499-506.
31. Centers for Disease Control and Prevention. Achievements in public health. Reduction in perinatal transmission of HIV infection - United States, 1985-2005. MMWR. 2006; 55:592-7.
32. Glass TR, De Geest S, Weber R et al. Correlates of self-reported nonadherence to antiretroviral therapy in HIV-infected patients: the Swiss HIV Cohort Study. J Acquir Immune Defic Syndr. 2006; 41:385- 92.
33. Nachega JB, Hislop M, Dowdy DW et al. Adherence to nonnucleoside reverse transcriptase inhibitor-based HIV therapy and virological outcomes. Ann Intern Med. 2007; 146:564-73. (Pubitemid 351650537)
34. Harrigan PR, Hogg RS, Dong WW et al. Predictors of HIV drug-resistance mutations in a large antiretroviral-naive cohort initiating triple antiretroviral therapy. J Infect Dis. 2005; 191:339-47. (Pubitemid 40139758)
35. Molina JM, Andrade-Villanueva J, Echevarria J et al. Once-daily atazanavir/ ritonavir versus twice-daily lopinavir/ ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008; 372:646-55.
36. Lennox JL, DeJesus E, Lazzarin A et al. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, doubleblind randomised controlled trial. Lancet. 2009; 374:796-806.
37. Ortiz R, Dejesus E, Khanlou H et al. Efficacy and safety of once-daily darunavir/ ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS. 2008; 22:1389-97.
38. Riddler SA, Haubrich R, DiRienzo AG et al. Class-sparing regimens for initialtreatment of HIV-1 infection. N Engl J Med. 2008; 358:2095-106. (Pubitemid 351679596)
39. Cooper DA, Heera J, Goodrich J et al. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis. 2010; 201:803-13.
40. Sax P, Tierney C, Collier AC et al. Abacavir-lamivudine versus tenofoviremtricitabine for initial HIV-1 therapy. N Engl J Med. 2009; 361:2230-40.
41. Smith KY, Patel P, Fine D et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ ritonavir for initial HIV treatment. AIDS. 2009; 23:1547-56.
42. Arribas JR, Pozniak AL, Gallant JE et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-week analysis. J Acquir Immune Defic Syndr. 2008; 47:74-8. (Pubitemid 351619372)
43. Mills AM, Nelson M, Jayaweera D et al. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009; 23:1679-88.
44. Eron J Jr, Yeni P, Gathe J Jr et al. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006; 368:476-82. (Pubitemid 44160731)
45. Walmsley S, Avihingsanon A, Slim J et al. Gemini: a noninferiority study of saquinavir/ ritonavir versus lopinavir/ritonavir as initial HIV-1 therapy in adults. J Acquir Immune Defic Syndr. 2009; 50:367-74.
46. First DataBank. First DataBank drug database. www.firstdatabank.com (accessed 2011 Mar 14).
47. Kakuda TN. Pharmacology of nucleoside and nucleotide reverse transcriptase inhibitor-induced mitochondrial toxicity. Clin Ther. 2000; 22:685-708. (Pubitemid 30451995)
48. Curran A, Ribera E. From old to new nucleoside reverse transcriptase inhibitors: changes in body fat composition, metabolic parameters and mitochondrial toxicity after the switch from thymidine analogs to tenofovir or abacavir. Expert Opin Drug Saf. Epub ahead of print.
49. Mallal S, Phillips E, Carosi G et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008; 358:568-79. (Pubitemid 351214284)
50. Sabin CA, Worm SW, Weber R et al. 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; 371:1417-26.
51. Strategies for Management of Anti-Retroviral Therapy/INSIGHT; DAD Study Groups. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients. AIDS. 2008; 22:F17-24.
52. Martin A, Bloch M, Amin J et al. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavirlamivudine: a randomized, 96-week trial. Clin Infect Dis. 2009; 49:1591-601.
53. Daar E, Tierney C, Fischl M et al. ACTG 5202: final results of ABC/3TC or TDF/FTC with either EFV or ATV/r in treatment-naïve HIV-infected patients. Paper presented at 17th Conference on Retroviruses and Opportunistic Infections. San Francisco, CA; 2010 Feb 17.
54. Brothers CH, Hernandez JE, Cutrell AG et al. Risk of myocardial infarction and abacavir therapy: no increased risk across GlaxoSmithKline- sponsored clinical trials in adult subjects. J Acquir Immune Defic Syndr. 2009; 51:20-8.
55. Martínez E, Larrousse M, Podzamczer D et al. Abacavir-based therapy does not affect biological mechanisms associated with cardiovascular dysfunction. AIDS. 2010; 24:F1-9.
56. Gallant JE, Staszewski S, Pozniak AL et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA. 2004; 292:191-201. (Pubitemid 38917996)
57. Woodward CL, Hall AM, Williams IG et al. Tenofovir-associated renal and bone toxicity. HIV Med. 2009; 10:482-7.
58. Tan LK, Gilleece Y, Mandalia S et al. Reduced glomerular filtration rate but sustained virologic response in HIV/ hepatitis B co-infected individuals on long-term tenofovir. J Viral Hepat. 2009; 16:471-8.
59. Hill A, van der Lugt J, Sawyer W et al. How much ritonavir is needed to boost protease inhibitors? Systematic review of 17 dose-ranging pharmacokinetic trials. AIDS. 2009; 23:2237-45.
60. Zeldin RK, Petruschke RA. Pharmacological and therapeutic properties of ritonavir-boosted protease inhibitor therapy in HIV-infected patients. J Antimicrob Chemother. 2004; 53:4-9. (Pubitemid 38072176)
61. Walmsley S, Bernstein B, King M et al. Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection. N Engl J Med. 2002; 346:2039-46. (Pubitemid 34680595)
62. Elzi L, Marzolini C, Furrer H et al. Treatment modification in human immunodeficiency virus-infected individuals starting combination antiretroviral therapy between 2005 and 2008. Arch Intern Med. 2010;170:57-65.
63. Chan-Tack KM, Truffa MM, Struble KA et al. Atazanavir-associated nephrolithiasis: cases from the US Food and Drug Administration's Adverse Event Reporting System. AIDS. 2007; 21:1215-8. (Pubitemid 46763296)
64. Klein CE, Chiu YL, Cai Y et al. Effects of acid-reducing agents on the pharmacokinetics of lopinavir/ritonavir and ritonavir-boosted atazanavir. J Clin Pharmacol. 2008;48:553-62. (Pubitemid 351503512)
65. Fagot JP, Mockenhaupt M, Bouwes- Bavinck JN et al. Nevirapine and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis. AIDS. 2001; 15:1843-8.
66. Stern JO, Robinson PA, Love J et al. A comprehensive hepatic safety analysis of nevirapine in different populations of HIV infected patients. J Acquir Immune Defic Syndr. 2003; 34(suppl 1):S21-33. (Pubitemid 37158630)
67. Mitsuya Y, Liu TF, Rhee SY et al. Prevalence of darunavir resistance-associated mutations: patterns of occurrence and association with past treatment. J Infect Dis. 2007; 196:1177-9. (Pubitemid 47580272)
68. Poveda E, de Mendoza C, Martin- Carbonero L et al. Prevalence of darunavir resistance mutations in HIV-1-infected patients failing other protease inhibitors. J Antimicrob Chemother. 2007; 60:885-8. (Pubitemid 47434272)
69. Bonta PI, Vermeulen JN, Speelman P et al. Severe abacavir hypersensitivity reaction in a patient tested HLA-B*5701 negative. AIDS. 2008; 22:1522-3.
70. Calza L, Rosseti N, Biagetti C et al. Abacavir-induced reaction with fever and severe skin rash in a patient tested human leukocyte antigen-B*5701 negative. Int J STD AIDS. 2009; 20:276-7.
71. Knobel H, Guelar A, Montero M et al. Risk of side effects associated with the use of nevirapine in treatment-naïve patients, with respect to gender and CD4 cell count. HIV Med. 2008; 9:14-8.
72. Van Leth F, Phanuphak P, Ruxrungtham K et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet. 2004; 363:1253-63. (Pubitemid 38496486)
73. Intelence (etravirine) package insert. Raritan, NJ: Tibotec Therapeutics; 2010 Dec.
74. Prezista (darunavir) package insert. Raritan, NJ: Tibotec Therapeutics; 2010 Dec.
75. Invirase (saquinavir mesylate) package insert. South San Francisco, CA: Genentech; 2010 Oct.
76. Aptivus (tipranavir) package insert. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals; 2010 Apr.