Virologic, immunologic, clinical, safety, and resistance outcomes from a long-term comparison of Efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1-infected persons

Mary van den Berg-Wolf, Katherine Huppler Hullsiek, Grace Peng, Michael J. Kozal, Richard M. Novak, Li Chen, Lawrence R. Crane, Rodger David MacArthur

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

Purpose: To compare long-term virologic, immunologic, and clinical outcomes in antiretroviral-naïve persons starting efavirenz (EFV)- versus nevirapine (NVP)-based regimens. Method: The FIRST study randomized patients into three strategy arms: PI+NRTI, NNRTI+NRTI, and PI+NNRTI+NRTI. NNRTI was determined by optional randomization (NVP or EFV) or by choice. For this randomized substudy, the primary endpoint was HIV RNA >50 copies/mL after 8 months or death. Genotypic resistance testing was done at virologic failure (VF; HIV RNA >1000 copies/mL at or after 4 months). Results: 228 persons (111 randomized to EFV, 117 to NVP) were followed for median 5 years. Rates per 100 person years for the primary endpoint were 41.2 (EFV) and 42.8 (NVP; p = .59). The percent of persons with HIV RNA <50 copies/mL was similar throughout follow-up (p = .24), as were average increases in CD4+ cells (p = .30). 423 persons declining the substudy chose EFV; 264 chose NVP. There were 915 persons in the combined cohort (randomized and choice). In the combined cohort, the risk of VF and VF with any NNRTI or NRTI resistance or resistance of any class was significantly less for EFV compared to NVP. Conclusions: EFV-based regimens as initial therapy resulted in a lower risk of VF and VF with resistance than did NVP-based regimens, although immunologic and clinical outcomes were similar.

Original languageEnglish (US)
Pages (from-to)324-336
Number of pages13
JournalHIV Clinical Trials
Volume9
Issue number5
DOIs
StatePublished - Sep 1 2008
Externally publishedYes

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efavirenz
Nevirapine
HIV-1
Safety
HIV
RNA
Therapeutics
Random Allocation

Keywords

  • HIV drug resistance
  • Initial antiretroviral therapy
  • NNRTI

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Virologic, immunologic, clinical, safety, and resistance outcomes from a long-term comparison of Efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1-infected persons. / van den Berg-Wolf, Mary; Hullsiek, Katherine Huppler; Peng, Grace; Kozal, Michael J.; Novak, Richard M.; Chen, Li; Crane, Lawrence R.; MacArthur, Rodger David.

In: HIV Clinical Trials, Vol. 9, No. 5, 01.09.2008, p. 324-336.

Research output: Contribution to journalArticle

van den Berg-Wolf, Mary ; Hullsiek, Katherine Huppler ; Peng, Grace ; Kozal, Michael J. ; Novak, Richard M. ; Chen, Li ; Crane, Lawrence R. ; MacArthur, Rodger David. / Virologic, immunologic, clinical, safety, and resistance outcomes from a long-term comparison of Efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1-infected persons. In: HIV Clinical Trials. 2008 ; Vol. 9, No. 5. pp. 324-336.
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T1 - Virologic, immunologic, clinical, safety, and resistance outcomes from a long-term comparison of Efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1-infected persons

AU - van den Berg-Wolf, Mary

AU - Hullsiek, Katherine Huppler

AU - Peng, Grace

AU - Kozal, Michael J.

AU - Novak, Richard M.

AU - Chen, Li

AU - Crane, Lawrence R.

AU - MacArthur, Rodger David

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N2 - Purpose: To compare long-term virologic, immunologic, and clinical outcomes in antiretroviral-naïve persons starting efavirenz (EFV)- versus nevirapine (NVP)-based regimens. Method: The FIRST study randomized patients into three strategy arms: PI+NRTI, NNRTI+NRTI, and PI+NNRTI+NRTI. NNRTI was determined by optional randomization (NVP or EFV) or by choice. For this randomized substudy, the primary endpoint was HIV RNA >50 copies/mL after 8 months or death. Genotypic resistance testing was done at virologic failure (VF; HIV RNA >1000 copies/mL at or after 4 months). Results: 228 persons (111 randomized to EFV, 117 to NVP) were followed for median 5 years. Rates per 100 person years for the primary endpoint were 41.2 (EFV) and 42.8 (NVP; p = .59). The percent of persons with HIV RNA <50 copies/mL was similar throughout follow-up (p = .24), as were average increases in CD4+ cells (p = .30). 423 persons declining the substudy chose EFV; 264 chose NVP. There were 915 persons in the combined cohort (randomized and choice). In the combined cohort, the risk of VF and VF with any NNRTI or NRTI resistance or resistance of any class was significantly less for EFV compared to NVP. Conclusions: EFV-based regimens as initial therapy resulted in a lower risk of VF and VF with resistance than did NVP-based regimens, although immunologic and clinical outcomes were similar.

AB - Purpose: To compare long-term virologic, immunologic, and clinical outcomes in antiretroviral-naïve persons starting efavirenz (EFV)- versus nevirapine (NVP)-based regimens. Method: The FIRST study randomized patients into three strategy arms: PI+NRTI, NNRTI+NRTI, and PI+NNRTI+NRTI. NNRTI was determined by optional randomization (NVP or EFV) or by choice. For this randomized substudy, the primary endpoint was HIV RNA >50 copies/mL after 8 months or death. Genotypic resistance testing was done at virologic failure (VF; HIV RNA >1000 copies/mL at or after 4 months). Results: 228 persons (111 randomized to EFV, 117 to NVP) were followed for median 5 years. Rates per 100 person years for the primary endpoint were 41.2 (EFV) and 42.8 (NVP; p = .59). The percent of persons with HIV RNA <50 copies/mL was similar throughout follow-up (p = .24), as were average increases in CD4+ cells (p = .30). 423 persons declining the substudy chose EFV; 264 chose NVP. There were 915 persons in the combined cohort (randomized and choice). In the combined cohort, the risk of VF and VF with any NNRTI or NRTI resistance or resistance of any class was significantly less for EFV compared to NVP. Conclusions: EFV-based regimens as initial therapy resulted in a lower risk of VF and VF with resistance than did NVP-based regimens, although immunologic and clinical outcomes were similar.

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KW - Initial antiretroviral therapy

KW - NNRTI

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