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Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials

KATLAMA, Christine ; HAUBRICH, Richard ; WOODFALL, Brian ; DE SMEDT, Goedele ; LALEZARI, Jacob ; LAZZARIN, Adriano ; MADRUGA, José V ; MOLINA, Jean-Michel ; SCHECHTER, Mauro ; PEETERS, Monika ; PICCHIO, Gaston ; VINGERHOETS, Johan

AIDS (London), 2009-11, Vol.23 (17), p.2289-2300 [Periódico revisado por pares]

Hagerstown, MD: Lippincott Williams & Wilkins

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Título:
Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials
Autor: KATLAMA, Christine ; HAUBRICH, Richard ; WOODFALL, Brian ; DE SMEDT, Goedele ; LALEZARI, Jacob ; LAZZARIN, Adriano ; MADRUGA, José V ; MOLINA, Jean-Michel ; SCHECHTER, Mauro ; PEETERS, Monika ; PICCHIO, Gaston ; VINGERHOETS, Johan
Assuntos: Acquired immune deficiency syndrome ; Adolescent ; Adult ; Aged ; AIDS/HIV ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; antiretroviral agents ; Antiretroviral Therapy, Highly Active ; Antiviral agents ; Biological and medical sciences ; Clinical trials ; Data processing ; Double-Blind Method ; Drug Resistance, Multiple, Viral ; Enfuvirtide ; Exanthema ; Female ; HIV Infections - drug therapy ; HIV-1 - drug effects ; Human health sciences ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunologie & maladie infectieuse ; Immunology & infectious disease ; Immunopathology ; Infectious diseases ; Male ; Medical sciences ; Middle Aged ; Mortality ; Mutation ; non-nucleoside reverse transcriptase inhibitors ; nucleosides ; Nucleotides ; Pharmacology. Drug treatments ; Proteinase inhibitors ; Pyridazines - pharmacology ; Pyridazines - therapeutic use ; Reverse Transcriptase Inhibitors - pharmacology ; Reverse Transcriptase Inhibitors - therapeutic use ; Ritonavir ; RNA-directed DNA polymerase ; safety engineering ; Sciences de la santé humaine ; Side effects ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Viral Load ; Young Adult
É parte de: AIDS (London), 2009-11, Vol.23 (17), p.2289-2300
Notas: ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
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ObjectType-Article-1
ObjectType-Feature-2
ObjectType-News-3
scopus-id:2-s2.0-70449368908
Descrição: To evaluate the efficacy, safety and virologic resistance profile of etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, over 48 weeks in treatment-experienced adults infected with HIV-1 strains resistant to a nonnucleoside reverse transcriptase inhibitor and other antiretrovirals. DUET-1 (NCT00254046) and DUET-2 (NCT00255099) are two identically designed, randomized, double-blind phase III trials. Patients received twice-daily etravirine 200 mg or placebo, each plus a background regimen of darunavir/ritonavir, investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors and optional enfuvirtide. Eligible patients had documented nonnucleoside reverse transcriptase inhibitor resistance, at least three primary protease inhibitor mutations at screening and were on a stable but virologically failing regimen for at least 8 weeks, with plasma viral load more than 5000 copies/ml. Pooled 48-week data from the two trials are presented. Patients (1203) were randomized and treated (n = 599, etravirine; n = 604, placebo). Significantly more patients in the etravirine than in the placebo group achieved viral load less than 50 copies/ml at week 48 (61 vs. 40%, respectively; P < 0.0001). Significantly fewer patients in the etravirine group experienced at least one confirmed or probable AIDS-defining illness/death (6 vs. 10%; P = 0.0408). Safety and tolerability in the etravirine group was comparable to the placebo group. Rash was the only adverse event to occur at a significantly higher incidence in the etravirine group (19 vs. 11%, respectively, P < 0.0001), occurring primarily in the second week of treatment. At 48 weeks, treatment-experienced patients receiving etravirine plus background regimen had statistically superior and durable virologic responses (viral load less than 50 copies/ml) than those receiving placebo plus background regimen, with comparable tolerability and no new safety signals reported since week 24.
Editor: Hagerstown, MD: Lippincott Williams & Wilkins
Idioma: Inglês

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Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials

KATLAMA, Christine ; HAUBRICH, Richard ; WOODFALL, Brian ; DE SMEDT, Goedele ; LALEZARI, Jacob ; LAZZARIN, Adriano ; MADRUGA, José V ; MOLINA, Jean-Michel ; SCHECHTER, Mauro ; PEETERS, Monika ; PICCHIO, Gaston ; VINGERHOETS, Johan

Hagerstown, MD: Lippincott Williams & Wilkins

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