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Efficacy and Tolerability of a Nucleoside Reverse Transcriptase Inhibitor-Sparing Combination of Lopinavir/Ritonavir and Efavirenz in HIV-1-Infected Patients

Allavena, Clotilde MD*; Ferré, Virginie PharmD, PhD†; Brunet-François, Cécile MD*; Delfraissy, Jean-François MD, PhD‡; Lafeuillade, Alain MD§; Valantin, Marc-Antoine MD∥; Bentata, Michelle MD¶; Michelet, Christian MD, PhD#; Poizot-Martin, Isabelle MD**; Dailly, Eric MD††; Launay, Odile MD¶; Raffi, François MD, PhD*; the Bitherapy Kaletra-Sustiva Study Group

JAIDS Journal of Acquired Immune Deficiency Syndromes: 1 July 2005 - Volume 39 - Issue 3 - pp 300-306
Clinical Science

Background: Recommended antiretroviral regimens include a nucleoside reverse transcriptase inhibitor (NRTI) component. Class cross-resistance and mitochondrial toxicity are recognized as problems with this class of antiretrovirals.

Methods: In a pilot open-label study, 65 antiretroviral-naive and 21 experienced but nonnucleoside reverse transcriptase inhibitor-naive HIV-1-infected adults were given a combination of lopinavir/ritonavir (533.3/133.3 mg twice daily) and efavirenz (600 mg once daily) for 48 weeks.

Results: At baseline, the mean viral load was 4.84 log10 copies/mL and the mean CD4 count was 311 cells/mm3. At week 24, the proportions of patients with a viral load <400 copies/mL were 78% and 93% using an intent-to-treat and on-treatment analysis, respectively. At week 48, proportions were 73% and 97%, respectively. Treatment discontinuation occurred in 21 patients during the 48-week period, with 33% of those attributable to drug-related adverse effects. A viral load >400 copies/mL at week 24 or 48 was associated with nonadherence in 3 patients and virologic failure in 1 patient. After an increase during the first 8 weeks, fasting lipid levels remained stable up to 48 weeks.

Conclusion: The lopinavir/ritonavir-efavirenz combination is associated with a high rate of virologic response and should be compared with more classic NRTI-containing regimens in randomized and controlled clinical trials.

From the *Service des Maladies Infectieuses et Tropicales/IFR26, Hôtel-Dieu, Nantes, France; †Laboratoire de Virologie/IFR26, Hôtel-Dieu, Nantes, France; ‡Service de Médecine Interne, Hôpital Bicêtre, Paris, France; ¶Service de Médecine Interne Hôpital Avicenne, Bobigny, France; §Service de Maladies Infectieuses, Hôpital Chalucet, Toulon, France; ∥Service de Maladies Infectieuses, Hôpital Pitié-Salpêtrière, Paris, France; #Service de Maladies Infectieuses, Hôpital Pontchaillou, Rennes, France; **Service d'Hématologie, Hôpital Sainte Marguerite, Marseille, France; and ††Laboratoire de Pharmacologie, Hôtel-Dieu, Nantes, France.

Received for publication November 29, 2004; accepted March 31, 2005.

Supported by the Association de Recherche sur le SIDA et les Infections des Immunodéprimés (ARSIID), Abbott Laboratories, and Bristol-Myers Squibb.

Reprints: François Raffi, Service des Maladies Infectieuses, Hôtel-Dieu, 1 Place Ricordeau, 44093 Nantes Cedex 1, France (e-mail: fraffi@chu-nantes.fr).

© 2005 Lippincott Williams & Wilkins, Inc.