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Efficacy and Tolerability of Stavudine plus Lamivudine in Treatment-Naive and Treatment-Experienced Patients with HIV-1 Infection

Christine Katlama, MD; Marc-Antoine Valantin, MD; Sophie Matheron, MD; Anne Coutellier, MD; Vincent Calvez, MD; Diane Descamps, MD; Christophe Longuet, MD; Manuela Bonmarchand, MD; Roland Tubiana, MD; Marcio De Sa, MD; Remi Lancar, MSc; Henri Agut, MD; Francoise Brun-Vezinet, MD; and Dominique Costagliola, PhD
[+] Article and Author Information

From Hopital Pitie-Salpetriere, Hopital Bichat-Claude Bernard, and INSERM SC4, Institut Saint Antoine de Recherche en Sante, Paris, France. Grant Support: By Agence Nationale de Recherche sur le SIDA, Paris, France. Acknowledgments: The authors thank the study and manuscript staff members who contributed to the study; the participants; the technical assistant (M. Pauchard); the pharmacists (M.H. Fievet, PhD, and A. Certain, PhD); Bristol-Myers Squibb, Inc. (J.J Gres, MD, and P. Ngovan, MD), and Glaxo Wellcome (D. Lapierre, MD, and A. Fetter, MD), which contributed study medication; and J. Hawes for assistance in manuscript preparation. Requests for Reprints: Christine Katlama, MD, Department of Infectious Diseases, Hopital Pitie-Salpetriere, 47, Boulevard de l'Hopital, 75013 Paris, France. Current Author Addresses: Drs. Katlama, Valantin, Tubiana, De Sa, and Agut: Department of Infectious Diseases, Hopital Pitie-Salpetriere, 47, Boulevard de l'Hopital, 75013 Paris, France.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1998;129(7):525-531. doi:10.7326/0003-4819-129-7-199810010-00003
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Background: A combination of two nucleoside analogues is currently the core of any antiretroviral regimen for HIV-1 infection. Stavudine plus lamivudine has shown an additive effect in vitro, as well as an absence of overlapping toxicity and cross-resistance.

Objective: To evaluate the antiviral efficacy of stavudine plus lamivudine in treatment-naive patients and in patients previously treated with other nucleoside reverse transcriptase inhibitors.

Design: Prospective, open-label pilot study.

Setting: Three urban clinical centers in Paris.

Patients: 83 patients with CD4+ cell counts between 50 and 400 cells/mm3 (42 treatment-naive and 41 treatment-experienced patients).

Interventions: Stavudine, 40 mg twice daily (30 mg twice daily in patients with a body weight ≤ 60 kg), and lamivudine, 150 mg twice daily.

Measurements: Primary end points for efficacy included changes in plasma viral load and CD4+ cell count at 24 weeks compared with baseline.

Results: Therapy with stavudine plus lamivudine resulted in a median decrease of 1.66 log10 (101.66) (range, −3.04 to −0.79 log10) in plasma HIV-1 RNA; the median increase in CD4+ cell count was 108 cells/mm3 (range, −58 to 406 cells/mm3) at week 24 in treatment-naive patients. In treatment-experienced patients, the median reduction in plasma HIV-1 RNA was 0.55 log10 (range, −2.86 to 0.52 log10), and the median increase in CD4+ cell count was 46 cells/mm3 (range, −188 to 311 cells/mm3). The percentages of patients with less than 3000 HIV-1 RNA copies/mL and less than 400 copies/mL at 24 weeks were, respectively, 57% (95% CI, 41% to 72%) and 26% (CI, 12% to 40%) among treatment-naive patients and 22% (CI, 10% to 38%) and 5% (CI, 1% to 17%) among treatment-experienced patients. Of 82 patients, 14 (17%) experienced grade 3 or 4 toxicity and 2 discontinued therapy because of intolerance toward treatment.

Conclusion: Stavudine plus lamivudine seems to have a potent antiviral effect in treatment-naive and treatment-experienced patients. No major drug-limiting toxicity was found. This two-nucleoside combination should be considered in multidrug therapy for HIV.

Figures

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Figure 1.
Median decrease in plasma viral load for treatment-naive (circles) and treatment-experienced (squares) patients over 24 weeks of therapy with stavudine plus lamivudine.

The numbers in parentheses are the numbers of treatment-naive patients/treatment-experienced patients.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Individual decrease in HIV-1 RNA viral load after 24 weeks measured against baseline HIV-1 RNA in treatment-naive patients.

The solid diagonal line represents the maximum benefit in viral load reduction that can be measured by using a technique with a lower limit of detection of 400 copies/mL. Thus, no data point (▵) can be located beyond this line. The closer the data point is to the line, the greater the efficacy of treatment.

Grahic Jump Location
Grahic Jump Location
Figure 3.
Median changes in CD4+ cell counts for treatment-naive (circles) and treatment-experienced (squares) patients over 24 weeks of therapy with stavudine plus lamivudine.

The numbers in parentheses are the numbers of treatment-naive patients/treatment-experienced patients.

Grahic Jump Location

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