Clinical Outcome of Patients with HIV-1 Infection according to Immunologic and Virologic Response after 6 Months of Highly Active Antiretroviral Therapy

  1. Sophie Grabar, MD, MPH;
  2. Vincent Le Moing, MD, MPH;
  3. Cécile Goujard, MD;
  4. Catherine Leport, MD, PhD;
  5. Michel D. Kazatchkine, MD, PhD;
  6. Dominique Costagliola, PhD; and
  7. Laurence Weiss, MD, PhD
  1. From Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Bichat Claude Bernard, and Hôpital Broussais, Paris, France; and Hôpital Bicêtre, Le Kremlin-Bicêtre, France.

    Abstract

    Background: The prognostic value of discordant immunologic (CD4 cell increase) and virologic (plasma HIV RNA level decrease) responses to antiretroviral treatment is not known.

    Objective: To study the relation between clinical outcome of HIV-infected patients receiving highly active antiretroviral therapy (HAART) and early immunologic and virologic responses to such therapy.

    Design: Prospective cohort study.

    Setting: 68 hospitals in France.

    Patients: 2236 protease inhibitor–naive patients.

    Intervention: Initiation of HAART with one protease inhibitor and two nucleoside analogues between July 1996 and March 1997.

    Measurements: Immunologic and virologic response at 6 months. Multivariate Cox models were used to assess the relation between these responses and progression to a new AIDS-defining event or death.

    Results: On the basis of 6-month immunologic and virologic responses, patients were classified into four groups: complete response (47.5%), complete nonresponse (16.2%), immunologic response only (19.0%), and virologic response only (17.3%). After month 6 and within a median of 18 months, 69 patients died and 123 experienced a new AIDS-defining event. After adjustment, complete nonresponders and those with only a virologic response had significantly higher risks for clinical progression at 6 months (relative risk, 3.38 [95% CI, 2.28 to 5.02] and 1.98 [CI, 1.26 to 3.10], respectively) than complete responders. The difference between complete responders and those with only an immunologic response at 6 months was weaker and nonsignificant (relative risk, 1.55 [CI, 0.96 to 2.50]).

    Conclusions: Immunologic response after 6 months of HAART indicates a favorable clinical outcome in HIV-infected patients regardless of virologic response. This suggests that both immunologic and virologic markers should be used in clinical practice to evaluate treatment response.

    Article and Author Information

    • For the Clinical Epidemiology Group of the French Hospital Database on HIV, see Appendix.

    • Acknowledgments: The authors thank all participants of the French Hospital Database on HIV and especially the research assistants, without whom this work would not have been possible.

    • Grant Support: The French Hospital Database on HIV is supported by the Agence Nationale de Recherches sur le SIDA (ANRS), the Fondation pour la Recherche Médicale (SIDACTION), INSERM, and the French Ministry of Health.

    • Requests for Single Reprints: Sophie Grabar, MD, MPH, INSERM SC4, Faculté de Médecine St. Antoine, 27 rue Chaligny, 75571 Paris Cedex 12, France.

    • Current Author Addresses: Drs. Grabar and Costagliola: INSERM SC4, Faculté de Médecine St. Antoine, 27 rue Chaligny, 75571 Paris Cedex 12, France.

    • Drs. Le Moing and Leport: Hôpital Bichat Claude Bernard, Service de Maladies Infectieuses et Tropicales, 46 rue Huchard, 75877 Paris Cedex 18, France.

    • Dr. Goujard: Hôpital Bicêtre, Service de Médecine Interne, 78 rue du Général Leclerc, 94275 Le Kremlin-Bicêtre, France.

    • Drs. Kazatchkine and Weiss: Hôpital Service d'Immunologie Clinique, Européen Georges Pompidon, 20 rue Leblanc, 75908 Paris Cedex 15, France.

    • Author Contributions: Conception and design: S. Grabar, D. Costagliola, L. Weiss.

    • Analysis and interpretation of the data: S. Grabar, V. Le Moing, C. Goujard, D. Costagliola, L. Weiss.

    • Drafting of the article: S. Grabar, V. Le Moing, C. Goujard, M.D. Kazatchkine, L. Weiss.

    • Critical revision of the article for important intellectual content: S. Grabar, V. Le Moing, C. Goujard, C. Leport, M.D. Kazatchkine, D. Costagliola, L. Weiss.

    • Final approval of the article: S. Grabar, V. Le Moing, C. Goujard, C. Leport, M.D. Kazatchkine, D. Costagliola, L. Weiss.

    • Statistical expertise: D. Costagliola.

    Summary for Patients

    • Summaries for Patients:Cell Count, Viral Load, and Clinical Outcome in Patients with HIV Infection after Highly Active Antiretroviral Therapy Ann Intern Med September 19, 2000 133:I-16
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    1. Ann Intern Med September 19, 2000 vol. 133 no. 6 401-410
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