Long-term results of initial therapy with abacavir and lamivudine combined with efavirenz, amprenavir/ritonavir, or stavudine

John A. Bartlett, Judy Johnson, Gisela Herrera, Nestor Sosa, Allan E Rodriguez, Qiming Liao, Sandy Griffith, David Irlbeck, Mark S. Shaefer

Research output: Contribution to journalArticle

78 Citations (Scopus)

Abstract

OBJECTIVE: To compare alternative class-sparing antiretroviral regimens in treatment-naive subjects. DESIGN: Open-label, multicenter, randomized trial of up to 3 consecutive treatment regimens over 96 weeks. METHODS: Two hundred ninety-one subjects received abacavir (ABC) and lamivudine and efavirenz (nonnucleoside reverse transcriptase inhibitors [NNRTIs]), ritonavir-boosted amprenavir (protease inhibitor [PI]), or stavudine (nucleoside reverse transcriptase inhibitor [NRTI]) by random assignment. The primary end points were the percentages of subjects with plasma HIV-1 RNA levels <400 copies/mL and time to treatment failure over 96 weeks. RESULTS: Ninety percent of subjects completed 96 weeks of follow-up, and 79% remained on study treatment. At week 96, there were no differences between arms in the percentages of subjects with plasma HIV-1 RNA levels <400 and <50 copies/mL, mean changes in plasma HIV-1 RNA levels, time to treatment failure, time to first or second virologic failure, or CD4 cell counts. The NNRTI arm had a greater percentages of subjects with RNA levels ≤50 copies/mL at weeks 24 and 48 and a greater overall duration of plasma HIV-1 RNA levels <400 copies/mL. Three subjects in the NNRTI arm had treatment failure on their first regimen and switched therapy compared with 16 in the NRTI arm and 13 in the PI arm. Twenty-one subjects had hypersensitivity reactions attributed to ABC (7.3%). Fewer drugs were used by subjects in the NNRTI arm, and fewer subjects in the NNRTI arm used 3 drug classes. CONCLUSIONS: All treatment regimens demonstrated excellent 96-week results. Secondary analyses favored the NNRTI regimen over the PI and NRTI regimens.

Original languageEnglish
Pages (from-to)284-292
Number of pages9
JournalJournal of Acquired Immune Deficiency Syndromes
Volume43
Issue number3
DOIs
StatePublished - Nov 1 2006

Fingerprint

efavirenz
Stavudine
Ritonavir
Reverse Transcriptase Inhibitors
RNA
HIV-1
Protease Inhibitors
Treatment Failure
Nucleosides
Therapeutics
lamivudine drug combination abacavir
amprenavir
CD4 Lymphocyte Count

Keywords

  • Class-sparing
  • Initial treatment
  • Sequencing
  • Treatment-naive

ASJC Scopus subject areas

  • Virology
  • Immunology

Cite this

Long-term results of initial therapy with abacavir and lamivudine combined with efavirenz, amprenavir/ritonavir, or stavudine. / Bartlett, John A.; Johnson, Judy; Herrera, Gisela; Sosa, Nestor; Rodriguez, Allan E; Liao, Qiming; Griffith, Sandy; Irlbeck, David; Shaefer, Mark S.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 43, No. 3, 01.11.2006, p. 284-292.

Research output: Contribution to journalArticle

Bartlett, John A. ; Johnson, Judy ; Herrera, Gisela ; Sosa, Nestor ; Rodriguez, Allan E ; Liao, Qiming ; Griffith, Sandy ; Irlbeck, David ; Shaefer, Mark S. / Long-term results of initial therapy with abacavir and lamivudine combined with efavirenz, amprenavir/ritonavir, or stavudine. In: Journal of Acquired Immune Deficiency Syndromes. 2006 ; Vol. 43, No. 3. pp. 284-292.
@article{acbff116f66445ebbd4ab6cd066df004,
title = "Long-term results of initial therapy with abacavir and lamivudine combined with efavirenz, amprenavir/ritonavir, or stavudine",
abstract = "OBJECTIVE: To compare alternative class-sparing antiretroviral regimens in treatment-naive subjects. DESIGN: Open-label, multicenter, randomized trial of up to 3 consecutive treatment regimens over 96 weeks. METHODS: Two hundred ninety-one subjects received abacavir (ABC) and lamivudine and efavirenz (nonnucleoside reverse transcriptase inhibitors [NNRTIs]), ritonavir-boosted amprenavir (protease inhibitor [PI]), or stavudine (nucleoside reverse transcriptase inhibitor [NRTI]) by random assignment. The primary end points were the percentages of subjects with plasma HIV-1 RNA levels <400 copies/mL and time to treatment failure over 96 weeks. RESULTS: Ninety percent of subjects completed 96 weeks of follow-up, and 79{\%} remained on study treatment. At week 96, there were no differences between arms in the percentages of subjects with plasma HIV-1 RNA levels <400 and <50 copies/mL, mean changes in plasma HIV-1 RNA levels, time to treatment failure, time to first or second virologic failure, or CD4 cell counts. The NNRTI arm had a greater percentages of subjects with RNA levels ≤50 copies/mL at weeks 24 and 48 and a greater overall duration of plasma HIV-1 RNA levels <400 copies/mL. Three subjects in the NNRTI arm had treatment failure on their first regimen and switched therapy compared with 16 in the NRTI arm and 13 in the PI arm. Twenty-one subjects had hypersensitivity reactions attributed to ABC (7.3{\%}). Fewer drugs were used by subjects in the NNRTI arm, and fewer subjects in the NNRTI arm used 3 drug classes. CONCLUSIONS: All treatment regimens demonstrated excellent 96-week results. Secondary analyses favored the NNRTI regimen over the PI and NRTI regimens.",
keywords = "Class-sparing, Initial treatment, Sequencing, Treatment-naive",
author = "Bartlett, {John A.} and Judy Johnson and Gisela Herrera and Nestor Sosa and Rodriguez, {Allan E} and Qiming Liao and Sandy Griffith and David Irlbeck and Shaefer, {Mark S.}",
year = "2006",
month = "11",
day = "1",
doi = "10.1097/01.qai.0000243092.40490.26",
language = "English",
volume = "43",
pages = "284--292",
journal = "Journal of acquired immune deficiency syndromes (1999)",
issn = "1525-4135",
publisher = "Lippincott Williams and Wilkins Ltd.",
number = "3",

}

TY - JOUR

T1 - Long-term results of initial therapy with abacavir and lamivudine combined with efavirenz, amprenavir/ritonavir, or stavudine

AU - Bartlett, John A.

AU - Johnson, Judy

AU - Herrera, Gisela

AU - Sosa, Nestor

AU - Rodriguez, Allan E

AU - Liao, Qiming

AU - Griffith, Sandy

AU - Irlbeck, David

AU - Shaefer, Mark S.

PY - 2006/11/1

Y1 - 2006/11/1

N2 - OBJECTIVE: To compare alternative class-sparing antiretroviral regimens in treatment-naive subjects. DESIGN: Open-label, multicenter, randomized trial of up to 3 consecutive treatment regimens over 96 weeks. METHODS: Two hundred ninety-one subjects received abacavir (ABC) and lamivudine and efavirenz (nonnucleoside reverse transcriptase inhibitors [NNRTIs]), ritonavir-boosted amprenavir (protease inhibitor [PI]), or stavudine (nucleoside reverse transcriptase inhibitor [NRTI]) by random assignment. The primary end points were the percentages of subjects with plasma HIV-1 RNA levels <400 copies/mL and time to treatment failure over 96 weeks. RESULTS: Ninety percent of subjects completed 96 weeks of follow-up, and 79% remained on study treatment. At week 96, there were no differences between arms in the percentages of subjects with plasma HIV-1 RNA levels <400 and <50 copies/mL, mean changes in plasma HIV-1 RNA levels, time to treatment failure, time to first or second virologic failure, or CD4 cell counts. The NNRTI arm had a greater percentages of subjects with RNA levels ≤50 copies/mL at weeks 24 and 48 and a greater overall duration of plasma HIV-1 RNA levels <400 copies/mL. Three subjects in the NNRTI arm had treatment failure on their first regimen and switched therapy compared with 16 in the NRTI arm and 13 in the PI arm. Twenty-one subjects had hypersensitivity reactions attributed to ABC (7.3%). Fewer drugs were used by subjects in the NNRTI arm, and fewer subjects in the NNRTI arm used 3 drug classes. CONCLUSIONS: All treatment regimens demonstrated excellent 96-week results. Secondary analyses favored the NNRTI regimen over the PI and NRTI regimens.

AB - OBJECTIVE: To compare alternative class-sparing antiretroviral regimens in treatment-naive subjects. DESIGN: Open-label, multicenter, randomized trial of up to 3 consecutive treatment regimens over 96 weeks. METHODS: Two hundred ninety-one subjects received abacavir (ABC) and lamivudine and efavirenz (nonnucleoside reverse transcriptase inhibitors [NNRTIs]), ritonavir-boosted amprenavir (protease inhibitor [PI]), or stavudine (nucleoside reverse transcriptase inhibitor [NRTI]) by random assignment. The primary end points were the percentages of subjects with plasma HIV-1 RNA levels <400 copies/mL and time to treatment failure over 96 weeks. RESULTS: Ninety percent of subjects completed 96 weeks of follow-up, and 79% remained on study treatment. At week 96, there were no differences between arms in the percentages of subjects with plasma HIV-1 RNA levels <400 and <50 copies/mL, mean changes in plasma HIV-1 RNA levels, time to treatment failure, time to first or second virologic failure, or CD4 cell counts. The NNRTI arm had a greater percentages of subjects with RNA levels ≤50 copies/mL at weeks 24 and 48 and a greater overall duration of plasma HIV-1 RNA levels <400 copies/mL. Three subjects in the NNRTI arm had treatment failure on their first regimen and switched therapy compared with 16 in the NRTI arm and 13 in the PI arm. Twenty-one subjects had hypersensitivity reactions attributed to ABC (7.3%). Fewer drugs were used by subjects in the NNRTI arm, and fewer subjects in the NNRTI arm used 3 drug classes. CONCLUSIONS: All treatment regimens demonstrated excellent 96-week results. Secondary analyses favored the NNRTI regimen over the PI and NRTI regimens.

KW - Class-sparing

KW - Initial treatment

KW - Sequencing

KW - Treatment-naive

UR - http://www.scopus.com/inward/record.url?scp=33750267263&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33750267263&partnerID=8YFLogxK

U2 - 10.1097/01.qai.0000243092.40490.26

DO - 10.1097/01.qai.0000243092.40490.26

M3 - Article

C2 - 16967040

AN - SCOPUS:33750267263

VL - 43

SP - 284

EP - 292

JO - Journal of acquired immune deficiency syndromes (1999)

JF - Journal of acquired immune deficiency syndromes (1999)

SN - 1525-4135

IS - 3

ER -