Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial.
BACKGROUND
We assessed a once-daily combination to simplify therapy in patients infected with human immunodeficiency virus type 1 (HIV-1).


METHODS
A total of 355 adults with plasma HIV-1 RNA levels <400 copies/mL were randomly assigned to either switch to once-daily emtricitabine, didanosine, and efavirenz (n=178) or maintain their protease inhibitor (PI)-based regimens (n=177). The primary end point was sustained suppression of plasma HIV-1 RNA levels to <400 copies/mL.


RESULTS
At week 48, the proportion of patients meeting the end point was 87.6% in the PI group and 90.5% in the once-daily group, with a treatment difference of -2.9% (upper bound of the 1-tailed 95% confidence interval, 2.6%). The proportion of patients with HIV-1 RNA levels <50 copies/mL was higher in the once-daily group (87%) than in the PI group (79%) (P<.05). Resistance mutations to efavirenz and emtricitabine were detected in all patients in the once-daily group who experienced virologic failure while receiving study medication. The proportion of patients discontinuing study medication because of adverse events was similar between the once-daily group (9%) and the PI group (10%) (P=.8).


CONCLUSIONS
Substituting a convenient once-daily combination of emtricitabine, didanosine, and efavirenz for a PI-based regimen was well tolerated and associated with sustained virologic suppression.
Molina
Jean-Michel
JM
Assistance-Publique Hopitaux de Paris, Paris, France. jean-michel.molina@sls.ap-hop-paris.fr
Journot
Valérie
V
Morand-Joubert
Laurence
L
Yéni
Patrick
P
Rozenbaum
Willy
W
Rancinan
Corinne
C
Fournier
Sandra
S
Morlat
Philippe
P
Palmer
Pierre
P
Dupont
Bertrand
B
Goujard
Cécile
C
Dellamonica
Pierre
P
Collin
Fidéline
F
Poizot-Martin
Isabelle
I
Chene
Geneviève
G
D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D048588:Benzoxazines; D003521:Cyclopropanes; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016049:Didanosine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D017320:HIV Protease Inhibitors; D010078:Oxazines; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D003841:Deoxycytidine; D000068679:Emtricitabine; C098320:efavirenz; D016049:Didanosine