TRIZAL study: Switching from successful HAART to Trizivir™ (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results

Christine Katlama, S. Fenske, B. Gazzard, A. Lazzarin, N. Clumeck, J. Mallolas, A. Lafeuillade, J. P. Mamet, L. Beauvais

Research output: Contribution to journalArticle

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Abstract

Objective. To assess the antiviral efficacy, safety, and adherence in subjects who switched to Trizivir™ following long-term HIV-1 RNA suppression. Study design. 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™ 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). Conclucion. Switching to Trizivir™ offers a potent and simplified regimen with equivalent efficacy and significant improvement in lipid abnormalities compared to continued triple therapy.

Original languageEnglish
Pages (from-to)79-86
Number of pages8
JournalHIV Medicine
Volume4
Issue number2
DOIs
Publication statusPublished - Apr 2003

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Zidovudine
Highly Active Antiretroviral Therapy
Tablets
Safety
HIV-1
Reverse Transcriptase Inhibitors
RNA
Therapeutics
Viral Load
Treatment Failure
Nucleosides
Trizivir
lamivudine drug combination abacavir
Incidence
Lymphocyte Count
Protease Inhibitors
Self Report
Antiviral Agents
Hypersensitivity
Triglycerides

Keywords

  • Protease inhibitor'sparing
  • Switch therapy
  • Trizivir™

ASJC Scopus subject areas

  • Virology
  • Medicine(all)
  • Immunology

Cite this

TRIZAL study : Switching from successful HAART to Trizivir™ (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results. / Katlama, Christine; Fenske, S.; Gazzard, B.; Lazzarin, A.; Clumeck, N.; Mallolas, J.; Lafeuillade, A.; Mamet, J. P.; Beauvais, L.

In: HIV Medicine, Vol. 4, No. 2, 04.2003, p. 79-86.

Research output: Contribution to journalArticle

Katlama, C, Fenske, S, Gazzard, B, Lazzarin, A, Clumeck, N, Mallolas, J, Lafeuillade, A, Mamet, JP & Beauvais, L 2003, 'TRIZAL study: Switching from successful HAART to Trizivir™ (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results', HIV Medicine, vol. 4, no. 2, pp. 79-86. https://doi.org/10.1046/j.1468-1293.2003.00139.x
Katlama, Christine ; Fenske, S. ; Gazzard, B. ; Lazzarin, A. ; Clumeck, N. ; Mallolas, J. ; Lafeuillade, A. ; Mamet, J. P. ; Beauvais, L. / TRIZAL study : Switching from successful HAART to Trizivir™ (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results. In: HIV Medicine. 2003 ; Vol. 4, No. 2. pp. 79-86.
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abstract = "Objective. To assess the antiviral efficacy, safety, and adherence in subjects who switched to Trizivir™ following long-term HIV-1 RNA suppression. Study design. 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™ 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). Conclucion. Switching to Trizivir™ offers a potent and simplified regimen with equivalent efficacy and significant improvement in lipid abnormalities compared to continued triple therapy.",
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AU - Fenske, S.

AU - Gazzard, B.

AU - Lazzarin, A.

AU - Clumeck, N.

AU - Mallolas, J.

AU - Lafeuillade, A.

AU - Mamet, J. P.

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AB - Objective. To assess the antiviral efficacy, safety, and adherence in subjects who switched to Trizivir™ following long-term HIV-1 RNA suppression. Study design. 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™ 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). Conclucion. Switching to Trizivir™ offers a potent and simplified regimen with equivalent efficacy and significant improvement in lipid abnormalities compared to continued triple therapy.

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