Effectiveness and safety of simplification therapy with once-daily tenofovir, lamivudine, and efavirenz in HIV-1-infected patients with undetectable plasma viral load on HAART.
OBJECTIVE
To evaluate the effectiveness and tolerability of a simplification regimen with tenofovir DF (TDF), lamivudine (3TC), and efavirenz (EFV) in HAART-experienced HIV-1-infected subjects with sustained viral suppression.


METHODS
Patients with HIV-1 RNA <200 copies/mL during the previous 6 months and who switched their current twice-daily or three-times-daily HAART to a simplified once-daily regimen of TDF (300 mg), 3TC (300 mg), and EFV (600 mg) were included.


RESULTS
154 patients (70% males, mean age 42 years) were included. Previous HAART included a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen in 55% of the patients and a thymidine analog in 87%. The percentage of patients with viral load <200 copies/mL in the intent-to-treat (ITT) data set was 83% at 6 months and 75% at 12 months (98% and 96%, respectively, in the on-treatment [OT] analysis). Five patients (3%) were identified as virologic failures according to the study protocol. The mean CD4 T-cell count increased significantly 12 months after simplification (from 570 to 632 cells/mm3; p < .01). At 12 months, mean triglyceride levels decreased from 233 to 170 mg/dL (p < .01) and mean cholesterol levels decreased from 205 to 189 mg/dL (p < .01). Thirty-three patients (21%) discontinued the study treatment prior to completing the 12-month follow-up.


CONCLUSIONS
Simplification to a once-daily regimen containing TDF, 3TC, and EFV is virologically and immunologically effective, well-tolerated, and safe with benefits in the lipid profile in the majority of patients.
Arrizabalaga
Julio
J
Unit of Infectious Diseases, Hospital Donostia, Donostia-San Sebastián, Spain. JARRIZ@terra.es
Arazo
Piedad
P
Aguirrebengoa
Koldo
K
García-Palomo
Daniel
D
Chocarro
Angel
A
Labarga
Pablo
P
Muñoz-Sánchez
María-José
MJ
Echevarría
Santiago
S
Oteo
José A
JA
Uriz
Javier
J
Letona
Santiago
S
Fariñas
M Carmen
MC
Peralta
Galo
G
Pinilla
Javier
J
Ferrer
Pedro
P
Alvarez
Maria-Luisa
ML
Iribarren
José A
JA
D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines / Q000008:administration & dosage* / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D002784:Cholesterol / Q000097:blood; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D010342:Patient Acceptance of Health Care; D012367:RNA, Viral / Q000097:blood; D000068698:Tenofovir; D016896:Treatment Outcome; D016312:Treatment Refusal; D014280:Triglycerides / Q000097:blood; D019562:Viral Load
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D063065:Organophosphonates; D012367:RNA, Viral; D014280:Triglycerides; D019259:Lamivudine; D002784:Cholesterol; D000068698:Tenofovir; D000225:Adenine; C098320:efavirenz