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

Sophie Grabar, MD, MPH; Vincent Le Moing, MD, MPH; Cécile Goujard, MD; Catherine Leport, MD, PhD; Michel D. Kazatchkine, MD, PhD; Dominique Costagliola, PhD; and Laurence Weiss, MD, PhD
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Copyright ©2004 by the American College of Physicians


Ann Intern Med. 2000;133(6):401-410. doi:10.7326/0003-4819-133-6-200009190-00007
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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.

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Figure 1.
Patient selection.

HAART = highly active antiretroviral therapy; NNRTI = non-nucleoside reverse transcriptase inhibitor. * 31 patients had a new AIDS-defining event before death.

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Figure 2.
Kaplan–Meier curves of progression to a new AIDS-defining event or death after 6 months of protease inhibitor–containing therapy, according to immunologic and virologic responses.910P

The top panel shows all 2236 HIV-infected study patients, the middle panel shows the 1728 treatment-experienced patients, and the bottom panel shows the 508 treatment-naive patients. IR+VR+ = immunologic and virologic response; IR+VR− = immunologic response, no virologic response; IR−VR+ = no immunologic response, virologic response; IR−VR− = no immunologic or virologic response. Immunologic response was defined as an increase in CD4 cell count from baseline of at least 0.05 × 10 cells/L. Virologic response was defined as a decrease in plasma HIV RNA level from baseline of at least 1 log copies/mL or an HIV RNA level that decreased to below 1000 copies/mL. < 0.001 for all comparisons.

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