Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection

Peter Ruane, Joseph Lang, Edwin DeJesus, Daniel S. Berger, Robin Dretler, Allan E Rodriguez, Douglas J. Ward, Michael L. Lim, Qiming Liao, Sunila Reddy, Marty St. Clair, Tania Vila, Mark S. Shaefer

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Objective: The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). Method: This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA <50 copies/mL for at least 3 months and a screening CD4+ cell count ≥200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Results: Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA <50 copies/mL was achieved for 94% of participants in the QD arm and 89% in the BID arm by intent-to-treat, missing = failure analysis (95% confidence interval for difference: ≥0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA > 120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. Conclusion: In this pilot study of patients suppressed on abacavir/ lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir/lamivudine/zidovudine qd plus EFV maintained virologic suppression, compared to 89% of participants continuing abacavir/ lamivudine/zidovudine bid plus EFV.

Original languageEnglish
Pages (from-to)229-236
Number of pages8
JournalHIV Clinical Trials
Volume7
Issue number5
DOIs
StatePublished - Sep 1 2006

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efavirenz
Zidovudine
HIV Infections
HIV-1
Tablets
Therapeutics
Flatulence
Random Allocation
Ambulatory Care Facilities
Nausea
Abdominal Pain
Multicenter Studies
Headache
lamivudine drug combination abacavir
Hypersensitivity
Genotype
HIV
RNA

Keywords

  • Abacavir
  • Anti-HIV agents
  • Efavirenz
  • HAART
  • HIV
  • Iamivudine
  • Once-daily patient compliance
  • Zidovudine

ASJC Scopus subject areas

  • Virology
  • Immunology

Cite this

Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection. / Ruane, Peter; Lang, Joseph; DeJesus, Edwin; Berger, Daniel S.; Dretler, Robin; Rodriguez, Allan E; Ward, Douglas J.; Lim, Michael L.; Liao, Qiming; Reddy, Sunila; St. Clair, Marty; Vila, Tania; Shaefer, Mark S.

In: HIV Clinical Trials, Vol. 7, No. 5, 01.09.2006, p. 229-236.

Research output: Contribution to journalArticle

Ruane, P, Lang, J, DeJesus, E, Berger, DS, Dretler, R, Rodriguez, AE, Ward, DJ, Lim, ML, Liao, Q, Reddy, S, St. Clair, M, Vila, T & Shaefer, MS 2006, 'Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection', HIV Clinical Trials, vol. 7, no. 5, pp. 229-236. https://doi.org/10.1310/Q457-57LP-2387-671W
Ruane, Peter ; Lang, Joseph ; DeJesus, Edwin ; Berger, Daniel S. ; Dretler, Robin ; Rodriguez, Allan E ; Ward, Douglas J. ; Lim, Michael L. ; Liao, Qiming ; Reddy, Sunila ; St. Clair, Marty ; Vila, Tania ; Shaefer, Mark S. / Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection. In: HIV Clinical Trials. 2006 ; Vol. 7, No. 5. pp. 229-236.
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abstract = "Objective: The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). Method: This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA <50 copies/mL for at least 3 months and a screening CD4+ cell count ≥200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97{\%}) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Results: Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA <50 copies/mL was achieved for 94{\%} of participants in the QD arm and 89{\%} in the BID arm by intent-to-treat, missing = failure analysis (95{\%} confidence interval for difference: ≥0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA > 120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3{\%}] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. Conclusion: In this pilot study of patients suppressed on abacavir/ lamivudine/zidovudine bid plus EFV, 94{\%} of participants switching to abacavir/lamivudine/zidovudine qd plus EFV maintained virologic suppression, compared to 89{\%} of participants continuing abacavir/ lamivudine/zidovudine bid plus EFV.",
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TY - JOUR

T1 - Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection

AU - Ruane, Peter

AU - Lang, Joseph

AU - DeJesus, Edwin

AU - Berger, Daniel S.

AU - Dretler, Robin

AU - Rodriguez, Allan E

AU - Ward, Douglas J.

AU - Lim, Michael L.

AU - Liao, Qiming

AU - Reddy, Sunila

AU - St. Clair, Marty

AU - Vila, Tania

AU - Shaefer, Mark S.

PY - 2006/9/1

Y1 - 2006/9/1

N2 - Objective: The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). Method: This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA <50 copies/mL for at least 3 months and a screening CD4+ cell count ≥200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Results: Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA <50 copies/mL was achieved for 94% of participants in the QD arm and 89% in the BID arm by intent-to-treat, missing = failure analysis (95% confidence interval for difference: ≥0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA > 120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. Conclusion: In this pilot study of patients suppressed on abacavir/ lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir/lamivudine/zidovudine qd plus EFV maintained virologic suppression, compared to 89% of participants continuing abacavir/ lamivudine/zidovudine bid plus EFV.

AB - Objective: The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). Method: This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA <50 copies/mL for at least 3 months and a screening CD4+ cell count ≥200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Results: Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA <50 copies/mL was achieved for 94% of participants in the QD arm and 89% in the BID arm by intent-to-treat, missing = failure analysis (95% confidence interval for difference: ≥0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA > 120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. Conclusion: In this pilot study of patients suppressed on abacavir/ lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir/lamivudine/zidovudine qd plus EFV maintained virologic suppression, compared to 89% of participants continuing abacavir/ lamivudine/zidovudine bid plus EFV.

KW - Abacavir

KW - Anti-HIV agents

KW - Efavirenz

KW - HAART

KW - HIV

KW - Iamivudine

KW - Once-daily patient compliance

KW - Zidovudine

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