Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials.
BACKGROUND
The T-20 Versus Optimized Background Regimen Only (TORO) 1 and TORO 2 clinical trials are open-label, controlled, parallel-group, phase 3 studies comparing enfuvirtide plus an optimized background (OB) of antiretrovirals (n = 661) with OB alone (n = 334) in treatment-experienced HIV-1-infected patients.


METHODS
The primary objective at week 48 was to investigate durability of efficacy, as measured by the percentage of patients maintaining their week 24 response or improving. Efficacy analyses used the intent-to-treat population.


RESULTS
A total of 73.7% of patients randomized to the enfuvirtide group remained on treatment through week 48 versus 21.3% originally randomized to the control group. At week 48, a higher proportion of week 24 responders maintained their response or were new responders in the enfuvirtide group than in the control group in each responder category: HIV-1 RNA level > or =1.0 log(10) change from baseline, <400 copies/mL and <50 copies/mL (37.4%, 30.4%, and 18.3% in the enfuvirtide group vs. 17.1%, 12.0%, and 7.8% in the control group, respectively; P < 0.0001 for all comparisons). CD4 cell count increases from baseline were twice as great in the enfuvirtide group as in the control group.


CONCLUSIONS
These data demonstrate durable efficacy of enfuvirtide plus OB over 48 weeks.
Nelson
Mark
M
Chelsea and Westminster Hospital, London, United Kingdom. mark.nelson@chelwest.nhs.uk
Arastéh
Keikawus
K
Clotet
Bonaventura
B
Cooper
David A
DA
Henry
Keith
K
Katlama
Christine
C
Lalezari
Jacob P
JP
Lazzarin
Adriano
A
Montaner
Julio S G
JS
O'Hearn
Mary
M
Piliero
Peter J
PJ
Reynes
Jacques
J
Trottier
Benoit
B
Walmsley
Sharon L
SL
Cohen
Calvin
C
Eron
Joseph J
JJ
Kuritzkes
Daniel R
DR
Lange
Joep
J
Stellbrink
Hans-Jürgen
HJ
Delfraissy
Jean-François
JF
Buss
Neil E
NE
Donatacci
Lucille
L
Wat
Cynthia
C
Smiley
Lynn
L
Wilkinson
Martin
M
Valentine
Adeline
A
Guimaraes
Denise
D
Demasi
Ralph
R
Chung
Jain
J
Salgo
Miklos P
MP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000008:administration & dosage / Q000627:therapeutic use*; D023581:HIV Fusion Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D013997:Time Factors; D019562:Viral Load
D019380:Anti-HIV Agents; D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D012367:RNA, Viral; D000077560:Enfuvirtide