Single-tablet regimens in HIV: Does it really make a difference?

Current Medical Research and Opinion

Volumn 30, Issue 1, 2014, Pages 89-97

  Aldir, Isabel ^a   Horta, Ana ^b   Serrado, Margarida ^c  

^a HOSPITAL EGAS MONIZ   (Portugal)

^b Centro Hospitalar Universitario do Porto   (Portugal)

^c HOSPITAL PULIDO VALENTE   (Portugal)

Author keywords

Fixed dose; HIV; Single tablet; STR

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; ATAZANAVIR PLUS RITONAVIR PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL FUMARATE; COBICISTAT PLUS ELVITEGRAVIR PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; DOLUTEGRAVIR; DOLUTEGRAVIR PLUS ABACAVIR PLUS LAMIVUDINE; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; EMTRICITABINE PLUS RILPIVIRINE PLUS TENOFOVIR DISOPROXIL; UNCLASSIFIED DRUG;

ABNORMAL DREAMING; ANTIVIRAL THERAPY; ASTHENIA; BEDTIME DOSAGE; BIOEQUIVALENCE; CENTRAL NERVOUS SYSTEM DISEASE; COST EFFECTIVENESS ANALYSIS; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DIARRHEA; DIET RESTRICTION; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FATIGUE; FATTY LIVER; HEADACHE; HEALTH CARE COST; HEALTH CARE DELIVERY; HEALTH CARE UTILIZATION; HEPATITIS B; HEPATOMEGALY; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HOSPITALIZATION; HOSPITALIZATION COST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HYPERLACTATEMIA; HYPOPHOSPHATEMIA; INSOMNIA; LACTIC ACIDOSIS; LIVER FAILURE; LIVER FUNCTION; MEDICATION COMPLIANCE; MENTAL DISEASE; META ANALYSIS; METABOLIC ACIDOSIS; MIXED INFECTION; NAUSEA; NEPHROTOXICITY; NEURAL TUBE DEFECT; NEUROLOGIC DISEASE; PHASE 3 CLINICAL TRIAL (TOPIC); PUBLICATION; QUALITY OF LIFE; RASH; RECOMMENDED DRUG DOSE; REVIEW; SCALE UP; SIDE EFFECT; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE; STEADY STATE; SYSTEMATIC REVIEW; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; VIRUS LOAD; VIRUS REPLICATION; VOMITING;

ADENINE; ANTI-HIV AGENTS; CARBAMATES; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; HIV INFECTIONS; HIV-1; HUMANS; NITRILES; ORGANOPHOSPHONATES; PYRIMIDINES; QUINOLONES; REVERSE TRANSCRIPTASE INHIBITORS; TABLETS; THIAZOLES;

EID: 84890505997     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2013.844685     Document Type: Review

References (62)

1. Goicoechea M, Best B. Efavirenz/emtricitabine/tenofovir disoproxil fumarate fixed-dose combination: First-line therapy for all? Expert Opin Pharmacother 2007;8:371-82
2. Mathias A, Hinkle J, Menning M, et al. Bioequivalence of efavirenz/emtricitabine/ tenofovir disoproxil fumarate single-Tablet regimen. J Acquir Immune Defic Syndr 2007;46:167-73
3. Airoldi M, Zaccarelli M, Bisi L, et al. One-pill once-A-day HAART: A simplification strategy that improves adherence and quality of life of HIV-infected subjects. Patient Preference and Adherence 2010;4:115-25
4. Willig JH, Abroms S, Westfall AO, et al. Increased regimen durability in the era of once-daily fixed-dose combination antiretroviral therapy. AIDS 2008;22:1951-60
5. Kilingley B, Pozniak A. The first once-daily single-Tablet regimen for the treatment of HIV-infected patients. Drugs Today 2007;43:427-42
6. Boyd MA. Improvements in antiretroviral therapy outcomes over calendar time. Curr Opin HIV AIDS 2009;4:194-9
7. Sax PE, Tierney C, Collier AC, et al. Abacavir/lamivudine versus tenofovir DF/ emtricitabine as part of combination regimens for initial treatment of HIV: Final results. J Infect Dis 2011;204:1191-201
8. Bangsberg DR, Ragland K, Monk A, et al. A single tablet regimen is associated with higher adherence and viral suppression than multiple tablet regimens in HIV homeless and marginally housed people. AIDS 2010;24:2835-40
9. Hodder SL, Mounzer K, DeJesus E, et al. Patient-reported outcomes in virologically suppressed, HIV-1-infected subjects after switching to a simplified, single-Tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care and STDs 2010;24:87-96
10. The European AIDS Clinical Society Guidelines. Version 6.1. European AIDS Clinical Society (EACS). Paris: EACS, November 2012. Available at: Http:// www.europeanaidsclinicalsociety.org/index.php?optioncom-content&view article&id59:eacs-guidelines&catid37:guidelines&Itemid41 [Last accessed July 2013
11. Thompson MA, Aberg JA, Hoy J, et al. IAS-USA Panel. Antiretroviral treatment of adult HIV infection-2012 recommendations of the International AIDS Society-USA panel. JAMA 2012;308:387-402
12. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Panel on Antiretroviral Guidelines for Adults and Adolescents. US: Department of Health and Human Services/AIDS Info, 12th February 2013. Available at: Http://www.aidsinfo.nih.gov/ContentFiles/ AdultandAdolescentGL.pdf [Last accessed May 2013
13. Statement released on HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. US: Department of Health and Human Services/AIDS Info, 18th September 2012. Available at: Http://aidsinfo.nih.gov/e-news/archive/2012/ 9/18 [Last accessed April 2013
14. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection-recommendations for a public health approach. World Health Organization (WHO), June 2013. Available at: Http:// www.who.int/hiv/pub/guidelines/arv2013/en/ [Last accessed September 2013
15. Atripla-summary of product characteristics. European Medicines Agency (EMA). London: EMA, 4th October 2011. Available at: Http://www.ema.europa. eu/ema/index.jsp?curlpages/medicines/human/medicines/000797/ human-med-000657.jsp&murlmenus/medicines/medicines.jsp&mid WC0b01ac058001d124 [Last accessed July 2013
16. Molina J-M, Cahn P, Grinsztejn B, et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-nai?ve adults infected with HIV-1 (ECHO): A phase 3 randomised double-blind active-controlled trial. Lancet 2011;378:238-46
17. Cohen CJ, Andrade-Villanueva J, Clotet B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-nai?ve adults infected with HIV-1 (THRIVE): A phase 3, randomised, non-inferiority trial. Lancet 2011;378:229-37
18. Stribild-summary of product characteristics. European Medicines Agency (EMA). London: EMA, 13th June 2013. Available at: Http://www.ema.europa. eu/ema/index.jsp?curlpages/medicines/human/medicines/002574/ human-med-001654.jsp&midWC0b01ac058001d124 [Last accessed July 2013
19. Cohen C, Davis K, Meyers J. Association of partial adherence to antiretroviral therapy with hospitalizations and healthcare costs in an HIV population. J Int AIDS Soc 2012;15:18060
20. Vera J, Aragäo F, Guimaräes M, et al. Benefits of ART simplification on adherence, clinical and economic outcomes. J Int AIDS Soc 2012;15:18064
21. Llibre JM, Antela A, Arribas JR, et al. El papel de las combinaciones de antirretrovirales a dosis fijas en el tratamiento de la infecció n por VIH-1. Enferm Infecc Microbiol Clin 2010;28:615-20
22. Guaraldi G, Orlando G, Zona S, et al. Premature age-related comorbidities among HIV-infected persons compared with the general population. Clin Infect Dis 2011;53:1120-6
23. Deeks ED, Perry CM. Efavirenz/emtricitabine/tenofovir disoproxil fumarate single-Tablet regimen (Atripla-): A review of its use in the management of HIV infection. Drugs 2010;70:2315-38
24. Mathias A, Menning M, Wiser L, et al. Bioequivalence of the emtricitabine/ rilpivirine/tenofovir disoproxil fumarate single tablet regimen. J Bioequiv Availab 2012;4:100-5
25. Schrijvers R, Desimmie BA, Debyser Z. Rilpivirine: A step forward in tailored HIV treatment. Lancet 2011;378:201-3
26. Eviplera-summary of product characteristics. European Medicines Agency (EMA). London: EMA, 16th April 2013. Available at: Http://www.ema.europa. eu/ema/index.jsp?curlpages/medicines/human/medicines/002312/ human-med-001514.jsp&midWC0b01ac058001d124 [Last accessed July 2013
27. Olin JL, Spooner LM, Klibanov OM. Elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate single tablet for HIV-1 infection treatment. Ann Pharmacother 2012;46:1671-7
28. German P, Warren D, West S, et al. Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-Tablet fixed-dose combination regimen for the treatment of HIV. J Acquir Immune Defic Syndr 2010;55:323-9
29. Cohen C, Elion R, Ruane P, et al. Randomized, phase 2 evaluation of two single-Tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. AIDS 2011;25:F7-12
30. Elion R, Gathe J, Rashbaum B, et al. The single-Tablet regimen elvitegravir/ cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; 'QUAD') maintains a high rate of virologic suppression, and cobicistat (COBI) is an effective pharmacoenhancer through 48 weeks. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC) 2010, Boston, USA. PH-938-B. Available at: Http://hivandhepatitis-com/2010-conference/ icaac/main.html#lib [Last accessed July 2013
31. Sax PE, DeJesus E, Mills A, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: A randomised, doubleblind, phase 3 trial, analysis of results after 48 weeks. Lancet 2012;379:2439-48
32. DeJesus E, Rockstroh JK, Henry K, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: A randomised, double-blind, phase 3, non-inferiority trial. Lancet 2012;379:2429-38
33. German P, Warren D, West S, et al. Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-Tablet fixed-dose combination regimen for the treatment of HIV. J Acquir Immune Defic Syndr 2010;55:323-9
34. Moyle G, Orkin C, Fisher M, et al. Switching to a single-Tablet regimen (STR) of Atripla- (ATR) from a 2 or 3-pill combination of the individual components (efavirenz [EFV], emtricitabine [FTC] and tenofovir df [TDF]) maintains virological suppression: Primary endpoint results of a 48-week, open-label study. HIV Med 2011;12(S1):79
35. DeJesus E, Rockstroh JK, Henry K, et al. Efficacy and safety of elvitegravir/ cobicistat/emtricitabine/tenofovir DF 'QUAD' compared to ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF in treatment nai?ve HIV-1 infected subjects. Conference for Retroviruses and Opportunistic Infections 2012;3:211
36. 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. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. US: Department of Health and Human Services/AIDS Info, 31st July 2012. Available at: Http://www.aidsinfo.nih.gov/contentfiles/lvguidelines/ PerinatalGL.pdf [Last accessed October 2012
37. DeJesus E, Young B, Morales-Ramirez JO, et al. Simplification of antiretroviral therapy to a single-Tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. J Acquir Immune Defic Syndr 2009;51:163-74
38. DeJesus E, Ruane P, McDonald C. Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/ lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine. HIV Clin Trials 2008;9:103-14
39. Lazzarin A, Johnson M, Ribera E, et al. The 5 year safety and efficacy of the once-daily antiretroviral-nai?ve patient regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir DF (TDF). J Int AIDS Soc 2010;13:P6
40. Cohen C, Wohl D, Arribas J, et al. STaR Study: Single-Tablet regimen emtricitabine/ rilpivirine/tenofovir DF is non-inferior to efavirenz/ emtricitabine/tenofovir DF in ART-nai?ve adults. J Int AIDS Soc 2012;15:18221
41. Fisher M, Palella F, Tebas P, et al. SPIRIT: Switching to emtricitabine/ rilpivirine/tenofovir DF single-Tablet regimen from boosted protease inhibitor maintains HIV suppression through week 48. J Int AIDS Soc 2012;15:18075
42. Zolopa A, Sax, PE, DeJesus E, et al. A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: Analysis of week 96 results. J Acquir Immune Defic Syndr 2013;63:96-100
43. Rockstroh JK, DeJesus E, Henry K, et al. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: Analysis of week 96 results. J Acquir Immune Defic Syndr 2013;62:483-6
44. Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis 2000;30:S171-6
45. Reis AC, Guerra M, Lencastre L. Treatment adherence, quality of life and clinical variables in HIV/AIDS infection. 10th International Congress on Drug Therapy in HIV Infection. J Int AIDS Soc 2010;13:P119
46. Maggiolo F. Efavirenz: A decade of clinical experience in the treatment of HIV. J Antimicrob Chemother 2009;64:910-28
47. Sax PE, Meyers JL, Mugavero MJ, et al. Adherence to antiretroviral treatment and correlation with risk of hospitalization among commercially insured HIV patients in the United States. PLoS ONE 2012;7:e31591
48. Bangalore S, Kamalakkannan G, Parkar S, et al. Fixed-dose combinations improve medication compliance: A meta-Analysis. Am J Med 2007;120: 713-19
49. Laurence J. Treating HIV infection with one pill per day. AIDS Patient Care and STDs 2006;20:601-3
50. Aragäo F, Cavaco M. Benefícios da simplificaç äo da terapê utica anti-retroviral na adesäo. XI Congresso Nacional de Doenças Infeciosas e Microbiologia Clínica & IX Congresso Nacional sobre SIDA. Porto, Portugal (2012). Poster P143
51. Juday T, Grimm K, Zoe-Powers A, et al. A retrospective study of HIV antiretroviral treatment persistence in a commercially insured population in the United States. AIDS Care 2011;23:1154-62
52. Gianotti N, Galli L, Bocchiola B, et al. Adherence, quality of life and number of daily pills in large cross-sectional study. J Int AIDS Soc 2010;13:P116
53. Edelman EJ, Gordon K, Justice AC, et al. Patient-reported symptoms on the antiretroviral regimen efavirenz/emtricitabine/tenofovir. AIDS Patient Care and STDs 2012;26:312-19
54. Colombo GL, Di Matteo S, Maggiolo F. Antiretroviral therapy in HIV-infected patients: A proposal to assess the economic value of the single-Tablet regimen. ClinicoEconomics and Outcomes Research 2013;5:59-68
55. Colombo GL, Colangeli V, Di Biagio A, et al. Cost-effectiveness analysis of initial HIV treatment under Italian guidelines. ClinicoEconomics and Outcomes Research 2011;3:197-205
56. Cohen C, Davis KL, Meyers JL. Association between daily antiretroviral pill burden and hospitalization risk in a medical population with HIV. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2011, Chicago, USA. Poster H2-791. Available at: Http://www.industrycortex. com/datasheets/profile/1253880109/poster-poster-number-h2-791-51st-interscience- conference-on-Ant [Last accessed July 2013
57. Cohen C, Davis KL, Meyers J. Effect of daily antiretroviral pill burden on healthcare utilization and costs in United States Medicaid enrollees with HIV. 13th European AIDS Conference (EACS) 2011, Belgrade, Serbia. Poster PE7.5/7. Available at: Http://www.abstractserver.com/eacsabstractarchive/ [Last accessed July 2013
58. Colombo GL, Castagna A, Salpietro S, et al. Cost-effectiveness evaluation of initial HAART regimens for managing HIV-infected patients according to real clinical practice. J Int AIDS Soc 2012;15:18386
59. Blasco AJ, Arribas JR, Clotet B. Aná lisis de costes y de coste/eficacia de las pautas preferentes de GESIDA para el tratamiento antirretroviral inicial. Enferm Infecc Microbiol Clin 2011;29:721-30
60. Aldir I, Doroana M, Oliveira J, et al. Cost-efficacy of European AIDS Clinical Society recommended initial antiretroviral regimens for treatment of HIV infection in Portugal. J Int AIDS Soc 2012;15:18374
61. Gouveia M, Costa J, Teó filo E, et al. Budget impact analysis of introducing a new single tablet regimen rilpivirine/emtricitabine/tenofovir for the treatment of HIV in Portugal. J Int AIDS Soc 2012;15:18375
62. Shionogi-ViiV Healthcare LLC Press release. Available at: Http:// www.gsk.com/media/pressreleases/2012/2012-pressrelease-1177620.htm [Last accessed April 2013