Efficacy and safety of a once-daily fixed-dose combination of abacavir/lamivudine compared with abacavir twice daily and lamivudine once daily as separate entities in antiretroviral-experienced hiv-1-infected patients (CAL30001 study)

Journal of Acquired Immune Deficiency Syndromes

Volumn 41, Issue 5, 2006, Pages 598-606

  Lamarca, Anthony ^a   Clumeck, Nathan ^b   Plettenberg, Andreas ^c   Domingo, Pere ^d   Fu, Kaisong ^e   Craig, Charles ^f   Zhao, Henry ^e   Watson, Maria ^e   Gordon, David ^g   Scott, Trevor ^e  

^a Therafirst Medical Center   (United States)

^b SAINT PIERRE UNIVERSITY HOSPITAL   (Belgium)

^c Institut fuer Interdisziplinaere Infektiologie und Immunologie GmbH   (Germany)

^d Hospital Sant Greu Y Sant Paublo   (Spain)

^e GLAXOSMITHKLINE   (United States)

^f Glaxo Smith Kline Research and Development   (United Kingdom)

^g GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Abacavir; Antiretroviral therapy; Fixed dose combination; HIV; Lamivudine

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; AMPRENAVIR; DIDANOSINE; EFAVIRENZ; INDINAVIR; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR PLUS RITONAVIR; NELFINAVIR; NEVIRAPINE; NEW DRUG; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; STAVUDINE; TENOFOVIR; VIRUS RNA; ZALCITABINE; ZIDOVUDINE;

ADULT; AGED; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BLOOD CHEMISTRY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG EXPOSURE; DRUG FIXED DOSE COMBINATION; DRUG HYPERSENSITIVITY; DRUG MIXTURE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; FATIGUE; FEMALE; HEADACHE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OPEN STUDY; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; VIROLOGIC RESPONSE; VIRUS LOAD; VIRUS MUTATION;

ADULT; AGED; ANTI-HIV AGENTS; DIDEOXYNUCLEOSIDES; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; LAMIVUDINE; MALE; MIDDLE AGED; SAFETY;

EID: 33646755880     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.qai.0000214821.33905.5c     Document Type: Article

References (41)

1. Department of Health and Human Services (DHHS) and the Henry J. Kaiser Family Foundation. Panel on clinical practices for treatment of HIV infection. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. Panel report; 23 March 2004.
2. Gulick RM, Mellors JW, Havlir D, et al. Simultaneous vs. sequential initiation of therapy with indinavir, zidovudine, and lamivudine for HIV-1 infection. JAMA. 1998;280:35-41.
3. Hirsch MS, Brun-Vezinet F, Clotet B, et al. Antiretroviral drug resistance testing in adults infected with human immunodeficiency virus type 1: 2003 recommendations of an International AIDS Society-USA Panel. Clin Infect Dis. 2003;37(1):113-128.
4. D'Aquila RT, Schapiro JM, Brun-Vezinet F, et al. Drug resistance mutations in HIV-1. Top HIV Med. 2003;11:92-96.
5. Iverson AK, Shafer RW, Wehrly K, et al. Multidrug-resistant human immunodeficiency virus type 1 strains resulting from combination antiretroviral therapy. J Virol. 1996;70:1086-1090.
6. Larder BA, Bloor S, Kemp SD, et al. A family of insertion mutations between codons 67 and 70 of human immunodeficiency virus type 1 reverse transcription confer multinucleoside analogue resistance. Antimicrob Agents Chemother. 1999;43:1961-1967.
7. Lanier ER, Ait-Khaled M, Scott J, et al. Antiviral efficacy of abacavir in antiretroviral therapy-experienced adults harbouring virus with specific patterns of resistance to nucleoside reverse transcriptase inhibitors. Antivir Ther. 2004;9:37-45.
8. Miller MD, Margot N, Lu B, et al. Genotypic and phenotypic predictors of the magnitude of response to tenofovir disoproxil fumarate treatment in antiretroviral-experienced patients. J Infect Dis. 2004;189(5):837-846.
9. Naeger LK, Margot NA, Miller MD. Increased drug susceptibility of HIV-1 reverse transcriptase mutants containing M184V and zidovudine-associated mutations: analysis of enzyme processivity, chain-terminator removal and viral replication. Antivir Ther. 2001;6(2):115-126.
10. Miller MD, Margot N, Coakley D, et al. Anti-HIV responses and development of RT mutations in antiretroviral-experienced patients adding tenofovir DF (TDF) therapy: baseline and week 24 genotypic analyses of study 907. Presented at: 41st Interscience Conference on Antimicrobial Agents and Chemotherapy; 2001; Chicago, IL.
11. Wainberg MA, Miller MD, Quan Y, et al. In vitro selection and characterization of HIV-1 with reduced susceptibility to PMPA. Antivir Ther. 1999;4:87-94.
12. StClair MH, Martin JL, Tudor-William G, et al. Resistance to ddI and sensitivity to AZT induced by a mutation in HIV-1 reverse transcriptase. Science. 1991;253:1557-1559.
13. Miller V, Ait-Khaled M, Stone C, et al. HIV-1 reverse transcriptase (RT) genotype and susceptibility to RT inhibitors during abacavir monotherapy and combination therapy. AIDS. 2000;14:163-171.
14. Srinivas RV, Fridland A. Antiviral activities of 9-R-2- phosphonomethoxypropyl adenine (PMPA) and bis (isopropyloxymethylcarbonyl) PMPA against various drug-resistant human immunodeficiency virus strains. Antimicrob Agents Chemother. 1998;42:1484-1487.
15. Larder BA, Kemp SD, Harrigan PR. Potential mechanism for sustained antiretroviral efficacy of AZT-3TC combination therapy. Science. 1995;269:696-699.
16. Gotte M, Arion D, Parniak MA, et al. The M184V mutation in the reverse transcriptase of human immunodeficiency virus type 1 impairs rescue of chain-terminated DNA synthesis. J Virol. 2000;74:3579-3585.
17. Tisdale M, Alnadaf T, Cousens D. Combination of mutations in human immunodeficiency virus type 1 reverse transcriptase required for resistance to the carbocyclic nucleoside 1592U89. Antimicrob Agents Chemother. 1997;41(5):1094-1098.
18. Harrigan PR, Stone C, Griffin P, et al. Resistance profile of the human immunodeficiency virus type 1 reverse transcriptase inhibitor abacavir (1592U89) after monotherapy and combination therapy. CNA2001 Investigative Group. J Infect Dis. 2000;181(3):912-920.
19. Lanier ER, Irlbeck D, Ross L, et al. Prediction of NRTI options by linking reverse transcriptase genotype to phenotypic breakpoints. Presented at: 10th Conference on Retroviruses and opportunistic infection; 2003; Boston, MA.
20. CDC. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Recomm Rep. 1992;18(41(RR-17)):1-19.
21. Division of AIDS. Division of AIDS table for grading the severity of adult adverse experiences. Rockville, MD: National Institute of Allergy and Infectious Diseases; 1992. Available at: http://rcc.tech-res-intl.com.
22. Schooley RT, Ruane P, Myers RA, et al. Tenofovir DF in antiretroviral-experienced patients: results from a 48-week, randomized, double-blind study. AIDS. 2002;16:1257-1263.
23. Food and Drug Administration. Guidance for Industry: Antiretroviral drugs using plasma HIV RNA measurements-clinical considerations for accelerated and traditional approval; October 2002.
24. Staszewski S, Keiser P, Montaner J, et al. Abacavir-lamivudine-zidovudine versus indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults. JAMA. 2001;285:1155-1163.
25. DeJesus E, Herrera G, Teofilo E, et al. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis. 2004;39:1038-1046.
26. Moyle G, DeJesus E, Cahn P, et al. Abacavir 600 mg once daily versus 300 mg twice-daily combined with lamivudine in combination with efavirenz (EFV) QD is well-tolerated and effective in the treatment of antiretroviral therapy (ART) naïve adults with HIV-1 infection (ZODIAC Study: CNA30021). J Acquir Immune Defic Syndr. 2005;38(4):417-425.
27. Bartlett JA, Johnson J, Herrera G, et al. Initial therapy with abacavir + lamivudine combined with efavirenz, amprenavir/ritonavir, or stavudine. Presented at: 15th International AIDS Conference; 2004; Bangkok, Thailand.
28. Gallant J, Rodriguez AE, Weinberg W et al. Efficacy of once-daily abacavir/lamivudine fixed-dose combination (ABC/3TC FDC) + efavirenz and subsequent treatment of tenofovir + ABC/3TC nonresponders: ESS30009 planned 24-week analysis. Presented at: 44th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2004; Washington, DC.
29. Gathe JC, Ive P, Wood R, et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir/ritonavir versus twice-daily nelfinavir in naive HIV-1 infected patients. AIDS. 2004;18(11):1529-1537.
30. Kewn S, Maher B, Hoggard PG, et al. The pharmacokinetics of abacavir phosphorylation in peripheral blood mononuclear cells from HIV-positive subjects. Presented at: 5th International Congress on Drug Therapy in HIV Infection; 2000; Glasgow, Scotland.
31. Harris M, Back D, Kewn S, et al. Intracellular carbovir triphosphate levels in patients taking abacavir once a day. AIDS. 2002;16:1197-1198.
32. Piliero P, Shachoy-Clark AD, Para M, et al. A Study Examining the Pharmacokinetics of Abacavir and the Intracellular Carbovir Triphosphate (CNA10905). Presented at: 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 2003; Chicago, IL.
33. Baker K, Lou Y, Yuen G, et al. The bioequivalence and effect of food on a new once-a-day fixed-dose combination tablet of abacavir (ABC) and lamivudine (3TC). Presented at: 44th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2004; Washington DC.
34. Farthing C, Khanlou H, Yeh V. Early virologic failure in a pilot study evaluating the efficacy of abacavir, lamivudine and tenofovir in treatment naive HIV-infected patients. Antivir Ther. 2003;8(suppl 1):S195. (Abstract 43).
35. Gallant JE, Rodriguez A, Weinberg W, et al. Early non-response to tenofovir DF (TDF) + abacavir (ABC) and lamivudine (3TC) in a randomised trial compared to efavirenz (EFV) + ABC and 3TC: ESS30009. Presented at: 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 2003; Chicago, IL.
36. Landman R, Peytavin G, Descamps D, et al. Low genetic barrier to resistance is a possible cause of early virologic failures in once-daily regimen of abacavir, lamivudine and tenofovir: The TONUS Study. Presented at: 11th Conference on Retroviruses and Opportunistic Infections; 2004; San Francisco, CA.
37. Jemsek J, Hutcherson P, Harper E. Poor virologic responses and early emergence of resistance in treatment naive, HIV-infected patients receiving a once daily triple nucleoside regimen of didanosine, lamivudine and tenofovir DF. Presented at: 11th Conference on Retroviruses and Opportunistic Infections; 2004; San Francisco, CA.
38. Jordan J, Delea T, Sherrill B et al. Impact of fixed dose combination zidovudine/lamivudine on adherence to antiretroviral therapy: a retrospective claims-based cohort study. Presented at: 6th International Congress on Drug Therapy in HIV Infection; 2002; Glasgow, Scotland.
39. Legorreta A, Yu A, Chernicoff H, et al. Adherence to combined lamivudine + zidovudine versus individual components: a community-based retrospective Medicaid claims analysis. AIDS Care. 2005;17(8):938-948.
40. Cutrell A, Hernandez J, Fleming J, et al. Updated clinical risk factor analysis of suspected hypersensitivity reactions to abacavir. Ann Pharmacother. 2004;38:2171-2172.
41. Clumeck N, LaMarca A, Fu K, et al. Safety and efficacy of a once daily (QD) fixed-dose combination (FDC) of ABC/3TC [FDC arm] versus ABC twice daily (BID) and 3TC QD as separate entities [SE arm] in ART-Experienced HIV-1 infected patients. Presented at: 44th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2004; Washington, DC.