Antiretroviral treatment simplification with 3 NRTIs or 2 NRTIs plus nevirapine in HIV-1-infected patients treated with successful first-line HAART.
OBJECTIVE
To assess the virologic noninferiority of an antiretroviral treatment simplification with coformulated zidovudine/lamivudine/abacavir (group 1) vs. coformulated zidovudine/lamivudine plus nevirapine (group 2) in HIV-1-infected patients receiving successful first-line highly active antiretroviral therapy.


METHODS
This is a prospective, multicenter, open-label, comparative, randomized, noninferiority study. A delta of 15% for differences in virologic suppression <200 copies/mL between groups was prespecified with a 1-sided 0.025 significance level.


RESULTS
A total of 134 patients were included into this study: 68 were allocated to group 1 and 66 to group 2. By intention-to-treat analysis (switch equals failure), the percentage of virologic suppression <200 copies/mL (<50 copies/mL) at week 48 was 71.0% (65.1%) and 73.0% (63.3%) in groups 1 and 2, respectively (estimate for differences [<200 copies/mL]: -2.1, 95% CI: -17.4-13.1, P=0.783). Thirteen and 14 patients in groups 1 and 2, respectively, discontinued therapy due to adverse events. Dyslipidemia improved in both groups, with a higher improvement in low-density lipoprotein cholesterol (P=0.049) in group 1.


CONCLUSIONS
Group 1 is not inferior to group 2 regarding virologic suppression <200 copies/mL. Both strategies improve lipid profile.
AIDS Care Unit, Lluita contra le SIDA Foundation, Germans Trias i Pujol Hospital, Universitat Autònoma de Barcelona, Spain. abonjoch@ns.hugtip.scs.es
Anna
A
Bonjoch
Roger
R
Paredes
Juan
J
Galvez
Celia
C
Miralles
Sebastia
S
Videla
Eva
E
Martínez
Jose
J
Miranda
Jose Antonio
JA
Muñoz-Moreno
Javier
J
De la Torre
Arturo
A
Prieto
Consuelo
C
Vilades
Bonaventura
B
Clotet
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015224:Dideoxynucleosides / Q000008:administration & dosage; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D009154:Mutation; D019829:Nevirapine / Q000008:administration & dosage*; D010349:Patient Compliance; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage*; D015215:Zidovudine / Q000008:administration & dosage; D000099227:Abacavir
D015224:Dideoxynucleosides; D019259:Lamivudine; D019829:Nevirapine; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D015215:Zidovudine; D000099227:Abacavir