Abacavir/lamivudine fixed dose combination in the treatment of patients with HIV infection

HIV Therapy

Volumn 3, Issue 1, 2009, Pages 19-29

  Anderson, Albert M L ^a   Lennox, Jeffrey L ^a  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Abacavir; AIDS; HIV; Lamivudine

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; ANTIRETROVIRUS AGENT; ATAZANAVIR; ATAZANAVIR PLUS RITONAVIR; COTRIMOXAZOLE; EFAVIRENZ; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; FOSAMPRENAVIR PLUS RITONAVIR; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR PLUS RITONAVIR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; TENOFOVIR; ZIDOVUDINE;

ANTIVIRAL THERAPY; ARTHRALGIA; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; COUGHING; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DOSE KIDNEY FUNCTION RELATION; DOSE RESPONSE; DRUG ALCOHOL INTERACTION; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG INTERMITTENT THERAPY; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FATTY LIVER; FOOD DRUG INTERACTION; HEART INFARCTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LACTIC ACIDOSIS; LIPOATROPHY; LIVER DISEASE; LIVER TOXICITY; MALAISE; METABOLIC DISORDER; MONOTHERAPY; MYALGIA; NAUSEA; NEUTROPENIA; PANCREATITIS; PATIENT SATISFACTION; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PREGNANCY; REVIEW; THROMBOCYTOPENIA; UNSPECIFIED SIDE EFFECT; VIRUS MUTATION; VIRUS RESISTANCE; VOMITING;

EID: 67149086833     PISSN: 17584310     EISSN: None     Source Type: Journal    
DOI: 10.2217/17584310.3.1.19     Document Type: Review

References (64)

1. Hall HI, Song R, Rhodes P et al.: Estimation of HIV incidence in the USA. JAMA 300(5), 520-529 (2008).
2. Mocroft A, Ledergerber B, Katlama C et al.: Decline in the AIDS and death rates in the EuroSIDA study: an observational study. Lancet 362(9377), 22-29 (2003).
3. Lohse N, Hansen AB, Pedersen G et al.: Survival of persons with and without HIV infection in Denmark, 1995-2005. Ann. Intern. Med. 146(2), 87-95 (2007).
4. Maggiolo F, Ravasio L, Ripamonti D et al.: Similar adherence rates favor different virologic outcomes for patients treated with nonnucleoside analogues or protease inhibitors. Clin. Infect. Dis. 40(1), 158-163 (2005).
5. Paterson DL, Swindells S, Mohr J et al.: Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann. Intern. Med. 133(1), 21-30 (2000).
6. Ammassari A, Murri R, Pezzotti P et al.: Self-reported symptoms and medication side effects influence adherence to highly active antiretroviral therapy in persons with HIV infection. J. Acquir. Immune Defic. Syndr. 28(5), 445-449 (2001).
7. Howard AA, Arnsten JH, Lo Y et al.: A prospective study of adherence and viral load in a large multicenter cohort of HIV-infected women. AIDS 16(16), 2175-2182 (2002).
8. Bass D, Smith M: HIV patients prefer once-daily regimens. Program and Abstracts of the 14th International AIDS Conference. Barcelona, Spain, 7-12 July 2002 (Abstract MoPeB3290).
9. Portsmouth SD, Osorio J, McCormick K, Gazzard BG, Moyle GJ: Better maintained adherence on switching from twice-daily to once-daily therapy for HIV: a 24 week randomized trial of treatment simplification using stavudine prolonged-release capsules. HIV Med. 6(3), 185-190 (2005).
10. Gazzard BG: British HIV Association Guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy. HIV Med. 9(8), 563-608 (2008).
11. Riddler SA, Haubrich R, DiRienzo AG et al.: Class-sparing regimens for initial treatment of HIV-1 infection. N. Engl. J. Med. 358(20), 2095-2106 (2008).
12. Epivir® , package insert, GlaxoSmithKline, Research Triangle Park, NC, USA.
13. Perry CM, Faulds D: Lamivudine. A review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV infection. Drugs 53(4), 657-680 (1997).
14. Ziagen® , package insert. GlaxoSmithKline, Research Triangle Park, NC, USA.
15. Hervey PS, Perry CM: Abacavir: a review of its clinical potential in patients with HIV infection. Drugs 60(2), 447-479 (2000).
16. Daluge SM, Good SS, Faletto MB et al.: 1592U89, a novel carbocyclic nucleoside analog with potent, selective antihuman immunodeficiency virus activity. Antimicrob. Agents Chemother. 41(5), 1082-1093 (1997).
17. Epzicom™, package insert, GlaxoSmithKline, Research Triangle Park, NC, USA.
18. Baker K, Lou Y, Yuen G, Murray S, Stein D: The bioequivalence and effect of food of 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. Washington, WA, USA, 30 October-2 November 2004 (Abstract A-458).
19. 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. 39(7), 1038-1046 (2004).
20. Gathe JC Jr, 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 18(11), 1529-1537 (2004).
21. Rodriguez-French A, Boghossian J, Gray GE et al.: The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. J. Acquir. Immune Defic. Syndr. 35(1), 22-32 (2004).
22. Yuen GJ, Lou Y, Bumgarner NF et al.: Equivalent steady-state pharmacokinetics of lamivudine in plasma and lamivudine triphosphate within cells following administration of lamivudine at 300 mg once daily and 150 mg twice daily. Antimicrob. Agents Chemother. 48(1), 176-182 (2004).
23. Harris M, Back D, Kewn S, Jutha S, Marina R, Montaner JS: Intracellular carbovir triphosphate levels in patients taking abacavir once a day. AIDS 16(8), 1196-1197 (2002).
24. Moyle GJ, DeJesus E, Cahn P et al.: Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen Once Daily in Antiretroviral Combination Study. J. Acquir. Immune Defic. Syndr. 38(4), 417-425 (2005).
25. Sosa N, Hill-Zabala C, DeJesus E et al.: Abacavir and lamivudine fixed-dose combination tablet once daily compared with abacavir and lamivudine twice daily in HIV-infected patients over 48 weeks (ESS30008, SEAL). J. Acquir. Immune Defic. Syndr. 40(4), 422-427 (2005).
26. Watson M, Hill-Zabala C, Sosa N, DeJesus E, Florance A: Patient satisfaction with abacavir (3TC)-lamivudine (3TC) fixed dose combination (FDC) tablet once daily (QD) compared with ABC and 3TC twice daily (BID) in HIV-1 infected patients (ESS 30008). Presented at: Third International AIDS Society Meeting on HIV Pathogenesis and Treatment. Rio de Janeiro, Brazil, 24-27 July 2005 (Abstract WePe6.3C08).
27. Lamarca A, Clumeck N, Plettenberg A et al.: 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). J. Acquir. Immune Defic. Syndr. 41(5), 598-606 (2006).
28. 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 noninferiority trial. Lancet 368(9534), 476-482 (2006).
29. Elion R, DeJesus E, Sension M et al.: Once-daily abacavir/lamivudine and ritonavir-boosted atazanavir for the treatment of HIV-1 infection in antiretroviral-naive patients: a 48-week pilot study. HIV Clin. Trials 9(3), 152-163 (2008).
30. Gallant JE, Rodriguez AE, Weinberg WG et al.: Early virologic nonresponse to tenofovir, abacavir and lamivudine in HIV-infected antiretroviral-naive subjects. J. Infect. Dis. 192(11), 1921-1930 (2005).
31. Landman R, Descamps D, Peytavin G et al.: Early virologic failure and rescue therapy of tenofovir, abacavir and lamivudine for initial treatment of HIV-1 infection: TONUS study. HIV Clin. Trials 6(6), 291-301 (2005).
32. Hammer SM, Eron JJ Jr, Reiss P et al.: Antiretroviral treatment of adult HIV infection: (2008) recommendations of the International AIDS Society-USA panel. JAMA 300(5), 555-570 (2008).
33. Smith K, Fine D, Patel P et al.: Efficacy and safety of abacavir/lamivudine compared with tenofovir/emtricitabine in combination with once daily lopinavir/ritonavir through 48 weeks of the HEAT study. Presented at: 15th Conference on Retroviruses and Opportunistic Infections. Boston, MA, USA, 3-6 February 2008 (Poster 774).
34. Sax P, Tierney C, Collier A et al.: ACTG (5202), shorter time to virologic failure with abacavir/lamivudine than tenofovir/ emtricitabine as part of combination therapy in treatment-naive subjects with screening HIV RNA 100,00 copies/ml or greater. Presented at: 17th International AIDS conference. Mexico City, Mexico, 3-8 August 2008 (Abstract THAB0303).
35. Smith K, Fine D, Patel P et al.: Similarity in efficacy and safety of abacavir/lamivudine compared with tenofovir/emtricitabine in combination with once daily lopinavir/ ritonavir over 96 weeks in the HEAT study. Presented at: 17th International AIDS conference. Mexico City, Mexico, 3-8 August 2008 (Abstract LBPE 1138).
36. Pappa K, Hernandez J, Ha B, Shaefer M, Brothers C, Liao Q: Abacavir/lamivudine shows robust virologic responses in ART-naive patients for baseline viral loads greater than or equal to 100,000 copies/ml and less than 100,000 copies/ml by endpoint used in ACTG (5202). Presented at: 17th International AIDS conference. Mexico City, Mexico, 3-8 August 2008 (Abstract THAB 0304).
37. Schuurman R, Nijhuis M, van LR et al.: Rapid changes in human immunodeficiency virus type 1 RNA load and appearance of drug-resistant virus populations in persons treated with lamivudine (3TC). J. Infect. Dis. 171(6), 1411-1419 (1995).
38. 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. 181(3), 912-920 (2000).
39. 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. 41(5), 1094-1098 (1997).
40. Brun-Vezinet F, Descamps D, Ruffault A et al.: Clinically relevant interpretation of genotype for resistance to abacavir. AIDS 17(12), 1795-1802 (2003).
41. Rakik A, Ait-Khaled M, Griffin P, Thomas TA, Tisdale M, Kleim JP: A novel genotype encoding a single amino acid insertion and five other substitutions between residues 64 and 74 of the HIV-1 reverse transcriptase confers high-level cross-resistance to nucleoside reverse transcriptase inhibitors. Abacavir CNA2007 International Study Group. J. Acquir. Immune Defic. Syndr. 22(2), 139-145 (1999).
42. Van LK, Witvrouw M, Balzarini J et al.: Patient HIV-1 strains carrying the multiple nucleoside resistance mutations are cross-resistant to abacavir. AIDS 14(4), 469-471 (2000).
43. Bartlett JA, Johnson J, Herrera G et al.: Long-term results of initial therapy with abacavir and lamivudine combined with efavirenz, amprenavir/ritonavir, or stavudine. J. Acquir. Immune Defic. Syndr. 43(3), 284-292 (2006).
44. Craig C, Stone C, Bonny T et al.: Analysis of virologic failure in a clinical trial of abacavir once daily versus twice daily with lamivudine and efavirenz. Presented at: 11th Conference on Retroviruses and Opportunistic Infections. San Francisco, CA, USA, 8-11 February 2004 (Abstract 551).
45. James A, Johann-Liang R: Increased rate and severity of abacavir-associated hypersensitivity reaction in randomized controlled clinical trials. Presented at: 12th Conference on Retroviruses and Opportunistic Infections. Boston, MA, USA, 22-25 February 2005 (Abstract 835).
46. Hetherington S, McGuirk S, Powell G et al.: Hypersensitivity reactions during therapy with the nucleoside reverse transcriptase inhibitor abacavir. Clin. Ther. 23(10), 1603-1614 (2001).
47. Cutrell AG, Hernandez JE, Fleming JW et al.: Updated clinical risk factor analysis of suspected hypersensitivity reactions to abacavir. Ann. Pharmacother. 38(12), 2171-2172 (2004).
48. Hetherington S, Hughes AR, Mosteller M et al.: Genetic variations in HLA-B region and hypersensitivity reactions to abacavir. Lancet 359(9312), 1121-1122 (2002).
49. Mallal S, Nolan D, Witt C et al.: Association between presence of HLA-B*5701, HLA-DR7 and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir. Lancet 359(9308), 727-732 (2002).
50. Mallal S, Phillips E, Carosi G et al.: HLA-B*5701 screening for hypersensitivity to abacavir. N. Engl. J. Med. 358(6), 568-579 (2008). ■ Prospective study that demonstrates the accuracy of the HLA-B*5701 test in identifying patients at high risk for abacavir hypersensitivity.
51. Bonta PI, Vermeulen JN, Speelman P, Prins JM: Severe abacavir hypersensitivity reaction in a patient tested HLA-B*5701 negative. AIDS 22(12), 1522-1523 (2008).
52. Young B, Squires K, Patel P et al.: First large, multicenter, open-label study utilizing HLA-B*5701 screening for abacavir hypersensitivity in North America. AIDS 22(13), 1673-1675 (2008).
53. Podzamczer D, Ferrer E, Sanchez P et al.: Less lipoatrophy and better lipid profile with abacavir as compared with stavudine: 96-week results of a randomized study. J. Acquir. Immune Defic. Syndr. 44(2), 139-147 (2007).
54. 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 multicohort collaboration. Lancet 371(9622), 1417-1426 (2008). ■■ First major study to identify an association between abacavir and cardiovascular disease.
55. Cutrell A, Brothers C, Yeo J, Hernandez J, Lapierre D: Abacavir and the potential risk of myocardial infarction. Lancet 371(9622), 1413 (2008).
56. Post FA, Campbell LJ: Abacavir and increased 56 risk of myocardial infarction. Lancet 372(9641), 803-805 (2008).
57. + count-guided interruption of antiretroviral treatment. N. Engl. J. Med. 355(22), 2283-2296 (2006).
58. Lundgren J, Neuhaus J, Babiker A et al.: Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the SMART study. Presented at: 17th International AIDS Conference. Mexico City, Mexico, 3-8 August 2008 (Abstract THAB0305).
59. Moyle GJ, Datta D, Mandalia S, Morlese J, Asboe D, Gazzard BG: Hyperlactataemia and lactic acidosis during antiretroviral therapy: relevance, reproducibility and possible risk factors. AIDS 16(10), 1341-1349 (2002).
60. Soriano V, Puoti M, Garcia-Gasco P et al.: Antiretroviral Drugs and liver injury. AIDS 22(1), 1-13 (2008).
61. Cohen CJ, Kubota M, Brachman PS et al.: Short-term safety and tolerability of a once-daily fixed-dose abacavir-lamivudine combination versus twice-daily dosing of abacavir and lamivudine as separate components: findings from the ALOHA study. Pharmacotherapy 28(3), 314-322 (2008).
62. World Health Organization/UNAIDS: 2007 AIDS epidemic update (2007). http://data.unaids.org/pub/EPISlides/2007/2007-epiupdate-en.pdf
63. USA Department of Health and Human Services (DHHS) Panel on antiretroviral guidelines for adults and adolescents. Guidelines for the use of antiretroviral agents in the treatment of HIV-1 infected adults and adolescents. 3 November 2008. http://aidsinfo.nih.gov/contentfiles/ adultandadolescentgl.pdf ■■ This is the newest edition of the major USA guideline for the treatment of HIV in antiretroviral-naive patients.
64. Stanford University HIV drug resistance database (Accessed August 2008). http://hivdb.stanford.edu.