The renaissance of fixed dose combinations: Combivir

Therapeutics and Clinical Risk Management

Volumn 3, Issue 4, 2007, Pages 579-583

  Portsmouth, Simon D ^a   Scott, Christopher J ^b  

^a ST MARY S HOSPITAL   (United Kingdom)

^b CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

Author keywords

Antiretroviral; Combivir; HAART; HIV; Lamivudine; Zidovudine

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; ANTIRETROVIRUS AGENT; DIDANOSINE; EFAVIRENZ; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; PLACEBO; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; TENOFOVIR; ZALCITABINE; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ANEMIA; ANTIVIRAL ACTIVITY; BLOOD BRAIN BARRIER; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DISEASE EXACERBATION; DRUG ABSORPTION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG PENETRATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FATTY LIVER; GOLD STANDARD; HEPATITIS B; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION RISK; INSOMNIA; LACTIC ACIDOSIS; LIPOATROPHY; MEGALOCYTOSIS; MONOTHERAPY; MORTALITY; MOUTH ULCER; MYOSITIS; NEPHROTOXICITY; NEUROLOGIC DISEASE; NEUTROPENIA; OCCUPATIONAL EXPOSURE; PERIPHERAL NEUROPATHY; REVIEW; RISK BENEFIT ANALYSIS; RISK REDUCTION; SUPERINFECTION; TABLET; VERTICAL TRANSMISSION; VIRUS LOAD; VIRUS MUTATION; VIRUS RESISTANCE;

EID: 34848892703     PISSN: 11766336     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (44)

1. Antiretroviral pregnancy register steering committee. Antiretroviral pregnancy registry international interim report 1 January 1989-31 July 2004. Wilmington, MC: Registry coordinating centre; 2004.
2. Cardo DM, et al. 1997. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centres for Disease Control and Prevention Needle stick Surveillance Group. N Engl J Med, 337:1485-90.
3. Carr A, Miller J, Law M, et al. 2000. A syndrome of lipoatrophy, lactic acidaemia and live dysfunction associated with HIV nucleoside analogue therapy: contribution to protease inhibitor related lipodystrophy syndrome. AIDS, 14(3):F25-32.
4. Castagna A, Danise A, Menzo S. 2006. Lamivudine monotherapy in HIV-1-infected patients harbouring a lamivudine-resistant virus: a randomized pilot study (E-184V study). AIDS, 20:795-803.
5. Concorde Coordinating committee 1994. Concorde: MRC/ANRS randomised double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection. Lancet, 343(8902):871-81.
6. Connor EM, et al. 1994. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Paediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med, 331(18):1173-80.
7. Cooper ER, et al. 2002. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr, 29:484-94.
8. Covington DL et al. 2004. Assessing teratogenicity of antiretroviral drugs: monitoring and analysis plan of the Antiretroviral Pregnancy Registry. Pharmacoepidemiol Drug Saf, 13(8):537-45.
9. DeJesus E, Herrera G, Teofilo E, et al. 2004. CNA30024 Study Team. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis, 39(7):1038-46.
10. Delta coordinating committee. 1996. Delta: a randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine with zidovudine alone in HIV-infected individuals. Lancet, 348:283-91.
11. Dronda F, Moreno S, Moreno A, et al. 2002. Long-term outcomes among antiretroviral naïve human immunodeficiency virus-infected patients with small increases in CD4+ cell counts after successful virologic suppression. Clin Infect Dis, 35(8):1005-9.
12. Dube MP, Zackin R, Tebas P, et al. 2002. Prospective study of regional body composition in antiretroviral-naïve subjects randomised to receive zidovudine + lamivudine or didanosine + stavudine combined with nelfinavir, efavirenz or both: A5005S, a substudy of ACTG 384. Antiviral Ther, 7:L18
13. Enting RH, Foudraine NA, Lange JM, et al. 1998. Cerebrospinal fluid HIV-1 RNA and drug concentrations after treatment with lamivudine plus zidovudine or stavudine. Lancet, 351:1547-51.
14. Fischl MA, Richman DD, Grieco MH, et al. 1987. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. A double-blind, placebo-controlled trial. N Engl J Med, 317(4):185-91.
15. Furman PA, Fyfe JA, St. Clair MH, et al. 1986. Phosphorylation of 3′-azido-3′-deoxythymidine and selective interaction of the 5′-triphosphate with human immunodeficiency virus reverse transcriptase. Proc Natl Acad Sci USA, 83:8333-7.
16. Gao Q, Gu Z, Parniak MA, et al. 1993. The same mutation that encodes low-level human immunodeficiency virus type 1 resistance to 2′-3′-dideoxyinosine and 2′,3′-dideoxycytidine confers high-level resistance to the (-) enantiomer of 2′,3′-dideoxy-3′-thiacytidine. Antimicrob Agents Chemother, 37(6):1390-2.
17. Gallant JE, Parish MA, Keruly JC, et al. 2005. Changes in renal function associated with tenofovir disoproxil fumarate treatment, compared with nucleoside reverse-transcriptase inhibitor treatment. Clin Infect Dis, 40(8):1194-8.
18. Gulick RM, Ribaudo HJ, Shikuma CM, et al. 2004. Triple-nucleoside regimens versus efavirenz containing regimens for initial treatment of HIV-1 infection. N Engl J Med, 350(18):1850-61
19. Hernandez JE, et al. 2003. Clinical risk factors for hypersensitivity reactions to abacavir: retrospective analysis of over 8,000 subjects receiving abacavir in 34 clinical trials. Abstract H-2013, 43rd ICAAC, Chicago, September 14-17th.
20. Ingrand D, Weber J, Boucher CA, et al. 1995. Phase I/II study of 3TC (lamivudune) I HIV-positive, asymptomatic or mild AIDS-related complex patients: sustained reduction in viral markers. AIDS, 9:1323-9.
21. Katlama C, Ingrand D, Loveday C, et al. 1996. Safety and efficacy of lamivudine-zidovudine combination therapy in antiretroviral-naïve patients. A randomised controlled comparison with zidovudine monotherapy. JAMA, 276:118-25.
22. + cell responses to new nucleoside regimens: switching to stavudine or adding lamivudine after prolonged zidovudine treatment of human immunodeficiency virus infection. AIDS res Hum Retroviruses, 16:1031-7.
23. Martin A, Smith DE, Carr A et al. 2004. Mitochondrial Toxicity Study Group. Reversibility of lipoatrophy in HIV-infected patients 2 years after switching from a thymidine analogue to abacavir: the MITOX Extension Study. AIDS, 18(7):1029-36.
24. Miranda LR, Gotte M, Liang F, Kuritzkes DR. 2005. The L74V mutation in human immunodeficiency virus type 1 reverse transcriptase counter-acts enhanced excision of zidovudine monophosphate associated with thymidine analog resistance mutations. Antimicrob Agents Chemother, 49:2648-56.
25. Mitsuya H, Weinhold KJ, Furman PA, et al. 1985. 3′azido-3′ deoxythymidine (BW A509U): an antiviral agent that inhibits the infectivity and cytopathic effect of human T-lymphotropic virus type III/ lymphadenopathy-associated virus in vitro. Proc Natl Acad Sci USA, 82(20):7096-100.
26. Mofenson LM, et al. 2002. Centres for Disease Control and Prevention, U.S. Public Health Service Task Force. U.S. Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. MMWR Recomm Rep, 51(RR-18):1-38
27. Palella FJ Jr, Delaney KM, Moorman AC, et al. 1998. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Eng J Med, 338(13):853-60.
28. Parikh UM, Bacheler L, Koontz D, Mellors JW 2006. The K65R mutation in human immunodeficiency type 1 reverse transcriptase exhibits bidirectional phenotypic antagonism with thymidine analog mutations. J Virol, 80:4971-7.
29. Pozniak AL, Gallant JE, Dejesus E et al. 2006. for the Study 934 Group. 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, 43:535-40.
30. Pluda JM, Coley TP, Montaner JS, et al. 1995. A phase I/II study of 2′deoxy-3′-thiacytidine (lamivudine) in patients with advanced human immunodeficiency virus infection. J Infect Dis, 171:1438-47.
31. Pollard RB, Hall D, Cassuro J, et al. 1999. Durable suppression of HIV with NVP/ZDV/3TC in treatment-naïve patients with advanced disease and high baseline viral loads. Abstract no 1218, 7th ECCATH, Lisbon.
32. Portsmouth SD, Osorio J, McCormick K, et al. 2005. 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):185-90.
33. Richmann DD, Fischl MA, Grieco MH, et al. 1987. The toxicity of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. A double-blind, placebo-controlled trial. N Engl J Med, 317(4):192-7.
34. Robbings GK, De Gruttola V, Shafer RW, et al. 2003. Comparisons of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med, 349:2291-301.
35. Staszewski S, Hill AM, Bartlett J, et al. 1997. Reductions in HIV-1 disease progression for zidovudine/lamivudine relative to control treatment: A meta-analysis of controlled trials. AIDS, 111:477-83.
36. Staszewski S, Loveday C, Picazo JJ, et al. 1996. Safety and efficacy of lamivudine-zidovudine combination therapy in zidovudine experienced patients. A randomised controlled comparison with zidovudine monotherapy. JAMA, 276:111-17.
37. Steigbigel R, Berty P, Teppler H, et al. 1996. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. Abstract no Mo.B.412, 11th World Aids Conference, Vancouver Canada.
38. Soudeyens H, Yao X, Gao Q, et al. 1991. Anti-Human Immunodeficiency Virus Type 1 activity and in vitro toxicity of 2′deoxy-3′-thiacytidine (BCH-189), a novel heterocyclic nucleoside analogue. Antimicrob agents Chemother, 35:1386-90.
39. Tisdale M, Kemp SD, Parry NR, et al. 1993. Rapid in-vitro selection of human immunodeficiency virus type 1 resistant to 3′ thiacytidine inhibitors due to a mutation in the YMDD region of reverse transcriptase. Proc Natl Acad Sci USA, 90(12):5653-6.
40. van Leeuwen R, Lange J, Hussey EK, et al. 1992. The safety and pharmacokinetics of a reverse transcriptase inhibitor, 3TC, in patients with HIV infection: a phase 1 study. AIDS, 6(12):1471-5.
41. 3. N Eng J Med, 322:941-9.
42. Winston A, Mandalia, Pillay D, et al. 2002. The prevalence and determinants of the K65R mutation in HIV-1 reverse transcriptase in tenofovir-naïve patients. AIDS, 16:2087-9
43. Yarchoan R, Berg G, Brouwers P, et al. 1987. Response of human-immunodeficiency-virus-associated neurological disease to 3′-azido3′-deoxythymidine. Lancet, 1(8528):132-5.
44. Yarchoan R, Klecker RW, Weingold KJ, et al. 1986. Administration of 3′-azido-3′deoxythymidine, an inhibitor of HTLV-III/LAV replication, to patients with AIDS hor AIDS related complex. Lancet, 1(8481):575-80