Substitution with lopinavir/ritonavir improves patient-reported outcomes including quality of life in patients who were intolerant to their antiretroviral therapy.
OBJECTIVE
Adverse effects are important determinants of quality of life (QOL) during highly active antiretroviral therapy (HAART). The PLATO study investigated the association between changes in patient-reported outcomes including QOL and substitution with lopinavir/ritonavir in patients experiencing side effects (SEs).


METHODS
HIV-1-infected participants (N = 849) with undetectable viral load experiencing Grade-2 SEs of the protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) component of their HAART regimen were randomized to immediate (baseline) or deferred (week 4) substitution with lopinavir/ritonavir soft-gel capsules 400/100 mg bid. The primary endpoint was change in the total score from the AIDS Clinical Trials Group (ACTG) Symptoms Distress Module (ASDM), supplemented with two items for nephrolithiasis. Secondary endpoints included Medical Outcomes Study (MOS)-HIV scores and Center for Epidemiologic Studies-Depression (CES-D) scores.


RESULTS
Immediate substitution resulted in improved ASDM total score at week 4 compared with deferred substitution (p <.001) and significant improvements in all MOS-HIV domains, while significant improvement was observed in CES-D scores at week 8. Primary SEs resolved at week 8 in 65% of participants in the immediate substitution group. Suppression of HIV-1 was maintained. Treatment was well-tolerated and associated with elevations in cholesterol and triglycerides.


CONCLUSIONS
Substitution with LPV/r improved patient-reported outcomes including QOL in patients experiencing Grade-2 SEs, while maintaining viral suppression.
Sprinz
Eduardo
E
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Brazil.
Neto
Andrade J
AJ
Bargman
Eduardo
E
Green
Stephen L
SL
Luo
Michelle P
MP
Sylte
Jacquelyn R
JR
McMillan
Florence I
FI
King
Kathryn R
KR
Rode
Richard A
RA
Brun
Scott C
SC
Hanna
George J
GJ
Podsadecki
Thomas J
TJ
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011744:Pyrimidinones / Q000627:therapeutic use*; D019438:Ritonavir / Q000627:therapeutic use*; D016896:Treatment Outcome
D011744:Pyrimidinones; D061466:Lopinavir; D019438:Ritonavir