TY - JOUR
T1 - Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials
AU - Katlama, Christine
AU - Haubrich, Richard
AU - Lalezari, Jacob
AU - Lazzarin, Adriano
AU - Madruga, José V.
AU - Molina, Jean-Michel
AU - Schechter, Mauro
AU - Peeters, Monika
AU - Picchio, Gaston
AU - Vingerhoets, Johan
AU - Woodfall, Brian
AU - de Smedt, Goedele
AU - AUTHOR GROUP
AU - Ariza, H. A.
AU - Benetucci, J.
AU - Cahn, P.
AU - Calanni, L. M.
AU - Cassetti, I.
AU - Corral, J.
AU - David, D. O.
AU - Krolewiecki, A.
AU - Losso, M. H.
AU - Patterson, P.
AU - Teijeiro, R. A.
AU - Grinsztejn, B.
AU - da Cunha, C. A.
AU - Kallas, E. G.
AU - Netto, E. M.
AU - Pilotto, J. H.
AU - Suleiman, J.
AU - Timerman, A.
AU - Ballesteros, J.
AU - Northland, R.
AU - Alvilés Montoya, A. A.
AU - Herrera Martinez, G.
AU - Solano Chinchilla, A.
AU - Dupon, M.
AU - Livrozet, J. M.
AU - Morlat, P.
AU - Pialoux, G.
AU - Piketty, C.
AU - Poizot-Martin, I.
AU - Andrade-Villanueva, J.
AU - Reyes-Terán, G.
AU - Sierra-Madero, J.
AU - Canton, A.
AU - Rodriguez, A.
AU - Sosa, N.
AU - Morales Ramirez, J. O.
AU - Prins, J. M.
AU - Frank, M.
PY - 2009
Y1 - 2009
N2 - OBJECTIVE: 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. DESIGN: DUET-1 (NCT00254046) and DUET-2 (NCT00255099) are two identically designed, randomized, double-blind phase III trials. METHODS: 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. RESULTS: 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. CONCLUSION: 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
AB - OBJECTIVE: 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. DESIGN: DUET-1 (NCT00254046) and DUET-2 (NCT00255099) are two identically designed, randomized, double-blind phase III trials. METHODS: 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. RESULTS: 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. CONCLUSION: 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
U2 - https://doi.org/10.1097/QAD.0b013e3283316a5e
DO - https://doi.org/10.1097/QAD.0b013e3283316a5e
M3 - Article
C2 - 19710593
SN - 0269-9370
VL - 23
SP - 2289
EP - 2300
JO - AIDS (London, England)
JF - AIDS (London, England)
IS - 17
ER -