TRIZAL study: switching from successful HAART to Trizivir (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results.
OBJECTIVE
To assess the antiviral efficacy, safety, and adherence in subjects who switched to Trizivir following long-term HIV-1 RNA suppression.


METHODS
A randomized, open-label, multicentre, 48-week comparative study in subjects who have received two nucleoside reverse transcriptase inhibitors plus a protease inhibitor or an nonnucleoside reverse transcriptase inhibitor or three nucleoside reverse transcriptase inhibitors for at least 6 months, with a history of undetectable plasma HIV-1 RNA since initiation of therapy and plasma viral load of < 50 HIV-1 RNA copies/mL at screening.


METHODS
Subjects were randomized 1:1 to continue their current treatment or to switch to a simplified treatment with Trizivir administered twice daily. Assessments included plasma HIV-1 RNA, lymphocyte counts, clinical laboratory evaluations, adverse events, and adherence to treatment (obtained via subject self-report). Treatment failure was defined as a plasma viral load of >/= 400 HIV-1 RNA copies/mL on two consecutive occasions or premature discontinuation of randomized treatment.


RESULTS
At week 48, the proportion of treatment failures in Trizivir arm (23/106, 22%) was noninferior to that observed in continued arm (23/103, 22%) with a treatment difference stratified by prior ART of 1.2%[-10.1; 12.5]. Incidence of adverse events was similar in both treatment groups. The incidence of possible hypersensitivity reaction in the Trizivir trade mark arm was 10%. Significant reductions in cholesterol and triglyceride plasma levels were observed in the Trizivir arm (P < 0.001 and P = 0.006, respectively).


CONCLUSIONS
Switching to Trizivir offers a potent and simplified regimen with equivalent efficacy and significant improvement in lipid abnormalities compared to continued triple therapy.
Katlama
C
C
Hôpital Pitié-Sâlpetrière, Paris, France. christine.katlama@psl.ap-hop-paris.fr
Fenske
S
S
Gazzard
B
B
Lazzarin
A
A
Clumeck
N
N
Mallolas
J
J
Lafeuillade
A
A
Mamet
J-P
JP
Beauvais
L
L
D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D000998:Antiviral Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002784:Cholesterol / Q000097:blood; D015224:Dideoxynucleosides / Q000627:therapeutic use*; D004338:Drug Combinations; D004342:Drug Hypersensitivity; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011480:Protease Inhibitors / Q000008:administration & dosage; D012367:RNA, Viral / Q000097:blood; D018709:Statistics, Nonparametric; D014280:Triglycerides / Q000097:blood; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use*; D000099227:Abacavir
D000998:Antiviral Agents; D002784:Cholesterol; D015224:Dideoxynucleosides; D004338:Drug Combinations; D019259:Lamivudine; D011480:Protease Inhibitors; D012367:RNA, Viral; D014280:Triglycerides; D015215:Zidovudine; C418262:abacavir, lamivudine, and zidovudine drug combination; D000099227:Abacavir