Virologic Response and Safety of the Abacavir/Lamivudine Fixed-Dose Formulation as Part of Highly Active Antiretroviral Therapy: Analyses of Six Clinical Studies

REFERENCES

• Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. January 29, 2008; 1–128. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed October 16, 2008.
   Google Scholar
• Riddler SA, Haubrich R, DiRienzo G, et al. Class-sparing regimens for initial treatment of HIV-1 infection. New Engl J Med. 2008;358:2095–2106.
   PubMed Web of Science ®Google Scholar
• 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. 2006;43:284–292.
   PubMed Web of Science ®Google Scholar
• Squires K, Lazzarin A, Gate!! JM, etal. Comparison of once-daily atazanavir with efavirenz, each in combina-tion with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV. J Acquir Immune Defic Syndr. 2004;36:1011–1109.
   PubMed Web of Science ®Google Scholar
• Sax P, Tierney C, Collier A, et al. ACTG 5202: shorter time to virologic failure (VF) with abacavir/lamivudine (ABC/3TC) than tenofovir/ emtricitabine (TDF/FTC) as part of combi-nation therapy in treatment-naïve subjects with screening HIV RNA 00,000 c/mL. In: Program and abstracts of the XVII International AIDS Conference; August 3–8, 2008; Mexico City, Mexico. Abstract THAB0303.
   Google Scholar
• Smith KY, Fine D, Patel P, et al. Efficacy and safety of abacavir/lamivudine compared to tenofovir/emtricitabine in combination with once-daily lopinavir/ritonavir through 48 weeks in the HEAT study. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections; February 2008; Boston. Poster 774.
   Google Scholar
• Elion R, DeJesus E, Sension M, et al. Once-daily abacavir/ lamivudine and ritonavir-boosted atazanavir for the treat-ment of HIV-1 infection in antiretroviral-naive patients: a 48-week pilot study. HIV Clin Trials. 2008; 9:152–163.
   PubMed Web of Science ®Google Scholar
• Eron JJ Jr, Yeni P, Gathe J, 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 non-inferiority trial. Lancet. 2006;368:476–482.
   PubMed Web of Science ®Google Scholar
• Gallant JE, Rodriguez AE, Weinberg WG, et al. Early viro-logic nonresponse to tenofovir, abacavir, and lamivudine in HIV-infected antiretroviral-naive subjects. J Infect Dis. 2005;192:1921–1930.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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. J Acquir Immune Defic Syndr. 2005;38:417–425.
   PubMed Web of Science ®Google Scholar
• Molina, J-M, Andrade-Villanueva J, Echevarria J, et al. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritona-vir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008; D01:10.1016/S0140–6736(08)61081–8.
   Google Scholar
• Ortiz R, DeJesus E, Khanloub H, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1-infected patients at week 48. AIDS. 2008;22:1389–1397.
   PubMed Web of Science ®Google Scholar
• Gathe J, da Silva BA, Louffy M, et al. Study M05-730 pri-mary efficacy results at week 48: Phase 3, randomized, open-label of lopinavir/ritonavir (LPV/r) tablets once daily (QD) versus twice daily (BID), co-ddministered with tenofovir DF (TDF)+emtricitabine (FTC) in antiretroviral-naive (ARV) HIV-1 infected subjects. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infec-tions; February 2008; Boston. Abstract 775.
   Google Scholar
• Phillips AN, Staszewski S, Weber R, et al. HIV viral load response to antiretroviral therapy according to the baseline CD4 cell count and viral load. JAMA. 2001286: 2560–2567.
   Google Scholar
• Ribaudo HJ, Kuritzkes DR, Lalama CM, et al. Efavirenz-based regimens in treatment-naive patients with a range of pretreatment HIV-1 RNA levels and CD4 cell counts. J Infect Dis. 2008;197:1006–1010.
   PubMed Web of Science ®Google Scholar
• Wolf E, Trein A, Schmidt W, et al. Similar virologic response rates for ART-naive subjects starting KVX+ LPV/4 or TVD+ LPV/4: data from the prospective observational STAR cohort. In: Program and abstracts of the 9th Inter-national Congress on Drug Therapy in HIV Infection; November 9–13, 2008; Glasgow. Abstract P7.
   Google Scholar
• Daniels RH, Gazzard BG, Holmes P, et al. Comparing the efficacy of Truvada and Kivexa combination therapy in HAART-naive individuals with different viral loads. In: Program and abstracts of the 9th International Congress on Drug Therapy in HIV Infection; November 9–13, 2008; Glasgow. Abstract P14.
   Google Scholar
• Eccleston KJ, Bambumba A, Babu CS, et al. Efficacy and safety of tenofovir/emtricitabine compared to abacavir/ lamivudine in HIV-1 infected patients in clinical setting: the TEAL study. In: Program and abstracts of the 9th International Congress on Drug Therapy in HIV Infection; November 9–13, 2008; Glasgow. Abstract P79.
   Google Scholar
• Kuritzkes DR, Lalama CM, Ribaudo HJ, et al. Preexisting resistance to nonnucleoside reverse-transcriptase inhibi-tors predicts virologic failure of an efavirenz-based regi-men in treatment-naive HIV-1-infected subjects. J Infect Dis. 2008;197:867–870.
   PubMed Web of Science ®Google Scholar
• Gulick RM, Ribaudo HJ, Shikuma CM, et al. Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 Infection. N Engl J Med. 2004;350:1850–1861.
   PubMed Web of Science ®Google Scholar