Journal Article

Week-12 Response to Therapy as a Predictor of Week 24, 48, and 96 Outcome in Patients Receiving the HIV Fusion Inhibitor Enfuvirtide in the T-20 versus Optimized Regimen Only (TORO) Trials

François Raffi, Christine Katlama, Michael Saag, Martin Wilkinson, Jain Chung, Lynn Smiley and Miklos Salgo

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 42, issue 6, pages 870-877
Published in print March 2006 | ISSN: 1058-4838
Published online March 2006 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/500206
Week-12 Response to Therapy as a Predictor of Week 24, 48, and 96 Outcome in Patients Receiving the HIV Fusion Inhibitor Enfuvirtide in the T-20 versus Optimized Regimen Only (TORO) Trials

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Background. Early virological response to antiretroviral therapy is predictive of long-term treatment outcome in therapy-naive patients. In treatment-experienced patients, such correlations are less well defined, because initial responses may be less pronounced and transient because of accumulated cross-resistance to prior therapies. Our objectives were to explore how the virological and immunological status of treatment-experienced patients at an early time point (week 12) during enfuvirtide-based therapy predicted their responses at weeks 24, 48, and 96 in the T-20 versus Optimized Regimen Only (TORO) trials.

Methods. Post hoc, modified, on-treatment and intent-to-treat analyses were performed to determine whether the relationship between virological and immunological outcomes at weeks 24, 48, and 96 were predicted by the patients' week-12 responses to therapy.

Results. Using a modified on-treatment analysis for patients who, by week 12, achieved a decrease in their HIV-1 RNA load of ⩾1 log10 copies/mL, 39.2% (95% CI, 33.6%–44.8%) and 59.5% (95% CI, 53.8%–65.1%) achieved a viral load of <50 copies/mL or <400 copies/mL at week 96, respectively, compared with 1.3% (95% CI, 0%–3.8%) and 2.6% (95% CI, 0%–6.1%) of patients, respectively, who did not achieve an early virological response. Using the same modified on-treatment analysis method for patients who, at week 12, achieved a CD4 cell count increase of ⩾50 cells/mm3, 87.2% (95% CI, 82.6–91.8) maintained or improved this response through week 96, compared with 56.6% (95% CI, 47.5–65.8) of patients who did not achieve this early categorical immunological response.

Conclusion. Enfuvirtide-based treatment regimens are associated with a rapid and durable response. Week-12 virological and immunological responses to treatment with enfuvirtide are predictive of subsequent outcomes in triple-class treatment—experienced patients.

Journal Article.  3949 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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