Cost–Effectiveness of CYP2B6 Genotyping to Optimize Efavirenz Dosing in HIV Clinical Practice

References

• Panel on Antiretroviral Guidelines for Adults and Adolescents . Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents ( 2015 ). https://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultAndAdolescentGL.pdf .
   Google Scholar
• Gulick RM , RibaudoHJ , ShikumaCMet al. Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial . JAMA296 ( 7 ), 769 – 781 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Daar ES , TierneyC , FischlMAet al. Atazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1 . Ann. Intern. Med.154 ( 7 ), 445 – 456 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Haas DW , RibaudoHJ , KimRBet al. Pharmacogenetics of efavirenz and central nervous system side effects: an Adult AIDS Clinical Trials Group study . AIDS18 ( 18 ), 2391 – 2400 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• Rotger M , ColomboS , FurrerHet al. Influence of CYP2B6 polymorphism on plasma and intracellular concentrations and toxicity of efavirenz and nevirapine in HIV-infected patients . Pharmacogenet. Genomics15 ( 1 ), 1 – 5 ( 2005 ).
   PubMedGoogle Scholar
• Haas DW , SmeatonLM , ShaferRWet al. Pharmacogenetics of long-term responses to antiretroviral regimens containing efavirenz and/or nelfinavir: an Adult AIDS Clinical Trials Group Study . J. Infect. Dis.192 ( 11 ), 1931 – 1942 ( 2005 ).
   PubMed Web of Science ®Google Scholar
• Holzinger ER , GradyB , RitchieMDet al. Genome-wide association study of plasma efavirenz pharmacokinetics in AIDS Clinical Trials Group protocols implicates several CYP2B6 variants . Pharmacogenet. Genomics22 ( 12 ), 858 – 867 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Wang J , SonnerborgA , RaneAet al. Identification of a novel specific CYP2B6 allele in Africans causing impaired metabolism of the HIV drug efavirenz . Pharmacogenet. Genomics16 ( 3 ), 191 – 198 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Ribaudo HJ , LiuH , SchwabMet al. Effect of CYP2B6, ABCB1, and CYP3A5 polymorphisms on efavirenz pharmacokinetics and treatment response: an AIDS Clinical Trials Group study . J. Infect. Dis.202 ( 5 ), 717 – 722 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Gatanaga H , HayashidaT , TsuchiyaKet al. Successful efavirenz dose reduction in HIV type 1-infected individuals with cytochrome P450 2B6 *6 and *26 . Clin. Infect. Dis.45 ( 9 ), 1230 – 1237 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Encore Study Group , PulsR , AminJet al.Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial . Lancet383 ( 9927 ), 1474 – 1482 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Encore1 Study Group . Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study . Lancet Infect. Dis.15 ( 7 ), 793 – 802 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Haas DW , SevereP , Jean JusteMA , PapeJW , FitzgeraldDW . Functional CYP2B6 variants and virologic response to an efavirenz-containing regimen in Port-au-Prince, Haiti . J. Antimicrob. Chemother.69 ( 8 ), 2187 – 2190 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Marzolini C , TelentiA , DecosterdLA , GreubG , BiollazJ , BuclinT . Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients . AIDS15 ( 1 ), 71 – 75 ( 2001 ).
   PubMed Web of Science ®Google Scholar
• Gallego L , BarreiroP , Del RioRet al. Analyzing sleep abnormalities in HIV-infected patients treated with efavirenz . Clin. Infect. Dis.38 ( 3 ), 430 – 432 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• Clifford DB , EvansS , YangYet al. Impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals . Ann. Intern. Med.143 ( 10 ), 714 – 721 ( 2005 ).
   PubMed Web of Science ®Google Scholar
• Gutierrez F , NavarroA , PadillaSet al. Prediction of neuropsychiatric adverse events associated with long-term efavirenz therapy, using plasma drug level monitoring . Clin. Infect. Dis.41 ( 11 ), 1648 – 1653 ( 2005 ).
   PubMed Web of Science ®Google Scholar
• Read TR , CareyD , MallonPet al. Efavirenz plasma concentrations did not predict cessation of therapy due to neuropsychiatric symptoms in a large randomized trial . AIDS23 ( 16 ), 2222 – 2223 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Takahashi M , IbeS , KudakaYet al. No observable correlation between central nervous system side effects and EFV plasma concentrations in Japanese HIV type 1-infected patients treated with EFV containing HAART . AIDS Res. Hum. Retroviruses23 ( 8 ), 983 – 987 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Martin AS , GomezAI , Garcia-BerrocalBet al. Dose reduction of efavirenz: an observational study describing cost–effectiveness, pharmacokinetics and pharmacogenetics . Pharmacogenomics15 ( 7 ), 997 – 1006 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Morris BL , ScottCA , WilkinTJet al. Cost–effectiveness of adding an agent that improves immune responses to initial antiretroviral therapy (ART) in HIV-infected patients: guidance for drug development . HIV Clin. Trials13 ( 1 ), 1 – 10 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Walensky RP , SaxPE , NakamuraYMet al. Economic savings versus health losses: the cost–effectiveness of generic antiretroviral therapy in the United States . Ann. Intern. Med.158 ( 2 ), 84 – 92 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Bristol-Myers Squibb Statement on Sustiva (efavirenz) in the U.S. ( 2014 ). http://news.bms.com/press-release/bristol-myers-squibb-statement-sustiva-efavirenz-us .
   Google Scholar
• Gold MR , SiegelJE , EinsteinMC . Cost–Effectiveness in Health and Medicine . Oxford University Press , NY, USA ( 1996 ).
   Google Scholar
• Braithwaite RS , GouletJ , KudelI , TsevatJ , JusticeAC . Quantifying the decrement in utility from perceived side effects of combination antiretroviral therapies in patients with HIV . Value Health11 ( 5 ), 975 – 979 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Gold HT , HallMJ , BlinderV , SchackmanBR . Cost effectiveness of pharmacogenetic testing for uridine diphosphate glucuronosyltransferase 1A1 before irinotecan administration for metastatic colorectal cancer . Cancer115 ( 17 ), 3858 – 3867 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Freedberg KA , LosinaE , WeinsteinMCet al. The cost effectiveness of combination antiretroviral therapy for HIV disease . N. Engl. J. Med.344 ( 11 ), 824 – 831 ( 2001 ).
   PubMed Web of Science ®Google Scholar
• Schackman BR , ScottCA , WalenskyRP , LosinaE , FreedbergKA , SaxPE . The cost–effectiveness of HLA-B*5701 genetic screening to guide initial antiretroviral therapy for HIV . AIDS22 ( 15 ), 2025 – 2033 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Schackman BR , FleishmanJA , SuAEet al. The lifetime medical cost savings from preventing HIV in the United States . Med. Care53 ( 4 ), 293 – 301 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Mellors JW , MuñozA , GiorgiJVet al. Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection . Ann. Intern. Med.126 ( 12 ), 946 – 954 ( 1997 ).
   PubMed Web of Science ®Google Scholar
• Freedberg KA , ScharfsteinJA , SeageGRIIIet al. The cost–effectiveness of preventing AIDS-related opportunistic infections . JAMA279 ( 2 ), 130 – 136 ( 1998 ).
   PubMed Web of Science ®Google Scholar
• Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents . Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America ( 2013 ). https://aidsinfo.nih.gov/contentfiles/lvguidelines/Adult_OI.pdf .
   Google Scholar
• Losina E , SchackmanBR , SadownikSNet al. Racial and sex disparities in life expectancy losses among HIV-infected persons in the United States: impact of risk behavior, late initiation, and early discontinuation of antiretroviral therapy . Clin. Infect. Dis.49 ( 10 ), 1570 – 1578 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Ross EL , WeinsteinMC , SchackmanBRet al. The clinical role and cost–effectiveness of long-acting antiretroviral therapy . Clin. Infect. Dis.60 ( 7 ), 1102 – 1110 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Sax PE , MeyersJL , MugaveroM , DavisKL . Adherence to antiretroviral treatment and correlation with risk of hospitalization among commercially insured HIV patients in the United States . PLoS ONE7 ( 2 ), e31591 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Pozniak AL , GallantJE , DejesusEet al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immunologic, and morphologic changes – a 96-week analysis . J. Acquir. Immune Defic. Syndr.43 ( 5 ), 535 – 540 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Sax PE , DejesusE , MillsAet al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, Phase 3 trial, analysis of results after 48 weeks . Lancet379 ( 9835 ), 2439 – 2448 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Thomson Corporation . Red Book: Pharmacy’s Fundamental Reference . Thomson PDR , NJ, USA ( 2014 ).
   Google Scholar
• Althoff KN , GangeSJ , KleinMBet al. Late presentation for human immunodeficiency virus care in the United States and Canada . Clin. Infect. Dis.50 ( 11 ), 1512 – 1520 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Hirsch JD , GonzalesM , RosenquistA , MillerTA , GilmerTP , BestBM . Antiretroviral therapy adherence, medication use, and health care costs during 3 years of a community pharmacy medication therapy management program for Medi-Cal beneficiaries with HIV/AIDS . J. Manag. Care Pharm.17 ( 3 ), 213 – 223 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Messou E , ChaixML , GabillardDet al. Increasing rate of TAMs and etravirine resistance in HIV-1-infected adults between 12 and 24 months of treatment: the VOLTART cohort study in Côte d’Ivoire, West Africa . J. Acquir. Immune Defic. Syndr.64 ( 2 ), 211 – 219 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• HIV Research Network . Hospital and outpatient health services utilization among HIV-infected patients in care in 1999 . J. Acquir. Immune Defic. Syndr.30 ( 1 ), 21 – 26 ( 2002 ).
   PubMed Web of Science ®Google Scholar
• Schackman BR , HaasDW , BeckerJEet al. Cost–effectiveness analysis of UGT1A1 genetic testing to inform antiretroviral prescribing in HIV disease . Antivir. Ther.18 ( 3 ), 399 – 408 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Scourfield A , ZhengJ , ChinthapalliSet al. Discontinuation of Atripla as first-line therapy in HIV-1 infected individuals . AIDS26 ( 11 ), 1399 – 1401 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Medicare Physician Fee Schedule ( 2013 ). www.cms.gov/apps/physician-fee-schedule/overview.aspx .
   Google Scholar
• Lubomirov R , ColomboS , Di IulioJet al. Association of pharmacogenetic markers with premature discontinuation of first-line anti-HIV therapy: an observational cohort study . J. Infect. Dis.203 ( 2 ), 246 – 257 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Cooper DA , HeeraJ , GoodrichJet 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.201 ( 6 ), 803 – 813 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Van Leth F , PhanuphakP , RuxrungthamKet 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 . Lancet363 ( 9417 ), 1253 – 1263 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• Di Iulio J , FayetA , Arab-AlameddineMet al. In vivo analysis of efavirenz metabolism in individuals with impaired CYP2A6 function . Pharmacogenet. Genomics19 ( 4 ), 300 – 309 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Haas DW , KwaraA , RichardsonDMet al. Secondary metabolism pathway polymorphisms and plasma efavirenz concentrations in HIV-infected adults with CYP2B6 slow metabolizer genotypes . J. Antimicrob. Chemother.69 ( 8 ), 2175 – 2182 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Kwara A , LarteyM , SagoeKW , RzekNL , CourtMH . CYP2B6 (c.516G-->T) and CYP2A6 (*9B and/or *17) polymorphisms are independent predictors of efavirenz plasma concentrations in HIV-infected patients . Br. J. Clin. Pharmacol.67 ( 4 ), 427 – 436 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Nachega JB , ParientiJJ , UthmanOAet al. Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: a meta-analysis of randomized controlled trials . Clin. Infect. Dis.58 ( 9 ), 1297 – 1307 ( 2014 ).
   PubMed Web of Science ®Google Scholar