Treatment with lamivudine, zidovudine, or both in hiv-positive patients with 200 to 500 cd4+ cells per cubic millimeter

Joseph J. Eron, Sharon L. Benoit, Joseph Jemsek, Rodger David MacArthur, Jorge Santana, Joseph B. Quinn, Daniel R. Kuritzkes, Mary Ann Fallon, Marc Rubin

Research output: Contribution to journalArticle

459 Citations (Scopus)

Abstract

The reverse-transcriptase inhibitor lamivudine has in vitro synergy with zidovudine against the human immunodeficiency virus (HIV). We studied the activity and safety of lamivudine plus zidovudine as compared with either drug alone as treatment for patients with HIV infection, most of whom had not previously received zidovudine. Three hundred sixty-six patients with 200 to 500 CD4+ cells per cubic millimeter who had received zidovudine for four weeks or less were randomly assigned to treatment with one of four regimens: 300 mg of lamivudine every 12 hours; 200 mg of zidovudine every 8 hours; 150 mg of lamivudine every 12 hours plus zidovudine; or 300 mg of lamivudine every 12 hours plus zidovudine. The study was double-blind and lasted 24 weeks, with an extension phase for another 28 weeks. Over the 24-week period, the low-dose and high-dose regimens combining lamivudine and zidovudine were associated with greater increases in the CD4+ cell count (P = 0.002 and P = 0.015, respectively) and the percentage of CD4+ cells (P<0.001 for both) and with greater decreases in plasma levels of HIV type 1 (HIV-1) RNA (P<0.001 for both) than was treatment with zidovudine alone. Combination therapy was also more effective than lamivudine alone in lowering plasma HIV-1 RNA levels and increasing the percentage of CD4+ cells (P<0.001 for all comparisons), and these advantages persisted through 52 weeks. Adverse events were no more frequent with combination therapy than with zidovudine alone. In HIV-infected patients with little or no prior antiretroviral therapy, treatment with a combination of lamivudine and zidovudine is well tolerated over a one-year period and produces more improvement in immunologic and virologic measures than does treatment with either agent alone.

Original languageEnglish (US)
Pages (from-to)1662-1669
Number of pages8
JournalNew England Journal of Medicine
Volume333
Issue number25
DOIs
StatePublished - Dec 21 1995
Externally publishedYes

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Lamivudine
Zidovudine
Therapeutics
HIV
HIV-1
RNA
Reverse Transcriptase Inhibitors
Virus Diseases
CD4 Lymphocyte Count
Double-Blind Method
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Treatment with lamivudine, zidovudine, or both in hiv-positive patients with 200 to 500 cd4+ cells per cubic millimeter. / Eron, Joseph J.; Benoit, Sharon L.; Jemsek, Joseph; MacArthur, Rodger David; Santana, Jorge; Quinn, Joseph B.; Kuritzkes, Daniel R.; Fallon, Mary Ann; Rubin, Marc.

In: New England Journal of Medicine, Vol. 333, No. 25, 21.12.1995, p. 1662-1669.

Research output: Contribution to journalArticle

Eron, Joseph J. ; Benoit, Sharon L. ; Jemsek, Joseph ; MacArthur, Rodger David ; Santana, Jorge ; Quinn, Joseph B. ; Kuritzkes, Daniel R. ; Fallon, Mary Ann ; Rubin, Marc. / Treatment with lamivudine, zidovudine, or both in hiv-positive patients with 200 to 500 cd4+ cells per cubic millimeter. In: New England Journal of Medicine. 1995 ; Vol. 333, No. 25. pp. 1662-1669.
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