Titre du document / Document title

Treatment intensification with abacavir in HIV-infected patients with at least 12 weeks previous lamivudine/zidovudine treatment

Auteur(s) / Author(s)

ROZENBAUM Willy ⁽¹⁾ ; KATLAMA Christine ⁽²⁾ ; MASSIP Patrice ⁽³⁾ ; BENTATA Michelle ⁽⁴⁾ ; ZUCMAN David ⁽⁵⁾ ; DELFRAISSY Jean-Francois ⁽⁶⁾ ; TREPO Christian ⁽⁷⁾ ; DAVID Frederique ⁽⁸⁾ ; LANIER E. Randall ⁽⁹⁾ ; VAVRO Cindy ⁽⁹⁾ ; MAMET Jean-Philippe ⁽⁵⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Maladies Infectieuses Trôpicales, Hôpital Rothschild, Paris, FRANCE
⁽²⁾ Maladies Infectieuses, Groupe Hospitalier Pitié-Salpétrière, Paris, FRANCE
⁽³⁾ Maladies Infectieuses Trôpicales, Hôpital de Purpan, Toulouse, FRANCE
⁽⁴⁾ Médecine Interne, Hôpital Avicenne, Bobigny, FRANCE
⁽⁵⁾ Médecine Interne, Hôpital Foch, Suresnes, FRANCE
⁽⁶⁾ Médecine Interne/Oncologie, Hôpital Kremlin-Bicêtre, Paris, FRANCE
⁽⁷⁾ Service D'Hépato-Gastro-Enterologie, Hotel-Dieu, Lyon, FRANCE
⁽⁸⁾ GlaxoWellcome, Marly le Roi, FRANCE
⁽⁹⁾ GlaxoWellcome Inc., Research Triangle Park, NC, ETATS-UNIS

Résumé / Abstract

Objectives: To demonstrate that lamivudine and zidovudine, given separately (lamivudine/zidovudine) or as a single combination tablet (Combivir⁾, had equivalent efficacy. To evaluate the safety and antiretroviral activity of intensification with abacavir in patients treated with lamivudine/zidovudine for ≥12 weeks. Design: A 12-week, equivalence study of lamivudine/ zidovudine versus Combivir. Patients who completed this study could enter a 48-week, intensification study of Combivir plus abacavir. Methods: In the equivalence study, treatment-naive patients were assessed for HIV-1 RNA, CD4 cell count and genotype. The same assessments plus phenotype were made in the intensification study. Serious adverse events were recorded in the equivalence study and all adverse events in the intensification study. Results: Lamivudine/zidovudine (n=40) and Combivir (n=35) gave equivalent reductions in plasma HIV-1 RNA levels at week 12. An identical proportion of patients (74%) in each treatment group harboured virus with the M184V mutation after 12 weeks. Fifty-two patients entered the intensification study and 44 completed 48 weeks of treatment. At the time of intensification with abacavir, all 35 patients with evaluable isolates harboured HIV-1 containing M184V. Addition of abacavir to Combivir led to further decreases in plasma HIV-1 RNA and increases in CD4 cell counts compared with the start of intensification (P<0.001 at week 48). After 48 weeks of triple therapy, multi-nucleoside resistance mutations at codons 69 and 151 were not detected in any patients. All treatment regimens were generally well tolerated. Conclusion: Lamivudine/zidovudine and Combivir have equivalent antiretroviral activity over 12 weeks. Adding abacavir to Combivir can be a safe and effective therapeutic option for patients, including those harbouring virus with the M184V mutation.

Revue / Journal Title

Antiviral therapy   ISSN 1359-6535 

Source / Source

Congrès
International Conference on Vaccine Development and Immunotherapy in HIV N^o2, San Juan , PORTO RICO (22/05/2001)
2001, vol. 6, n^o 2, pp. S69-S142 (53 p.)  (17 ref.), pp. 135-142

Langue / Language

Anglais

Editeur / Publisher

International Medical Press, London, ROYAUME-UNI  (1996) (Revue)

Mots-clés anglais / English Keywords

Lamivudine ; Zidovudine ; Abacavir ; Antiviral ; HIV-1 virus ; Human ; AIDS ; Drug combination ; Drug interaction ; Toxicity ; Oral administration ; Chemotherapy ; Treatment ; Clinical trial ; Dideoxynucleoside ; Pyrimidine nucleoside ; Purine nucleoside ; Human immunodeficiency virus ; Lentivirus ; Retroviridae ; Virus ; Viral disease ; Infection ; Immunopathology ; Immune deficiency ;

Mots-clés français / French Keywords

Lamivudine ; Zidovudine ; Abacavir ; Antiviral ; Virus HIV1 ; Homme ; SIDA ; Association médicamenteuse ; Interaction médicamenteuse ; Toxicité ; Voie orale ; Chimiothérapie ; Traitement ; Essai clinique ; Didésoxynucléoside ; Pyrimidine nucléoside ; Purine nucléoside ; Nucléoside analogue ; Virus immunodéficience humaine ; Lentivirus ; Retroviridae ; Virus ; Virose ; Infection ; Immunopathologie ; Immunodéficit ;

Mots-clés espagnols / Spanish Keywords

Lamivudina ; Zidovudina ; Abacavir ; Antiviral ; HIV-1 virus ; Hombre ; SIDA ; Asociación medicamentosa ; Interacción medicamentosa ; Toxicidad ; Vía oral ; Quimioterapia ; Tratamiento ; Ensayo clínico ; Didesoxinucleósido ; Pirimidina nucleósido ; Purina nucleósido ; Human immunodeficiency virus ; Lentivirus ; Retroviridae ; Virus ; Virosis ; Infección ; Inmunopatología ; Inmunodeficiencia ;

Localisation / Location

INIST-CNRS, Cote INIST : 27047, 35400009846198.0070