Stavudine toxicity in women is the main reason for treatment change in a 3-year prospective cohort of adult patients started on first-line antiretroviral treatment in Uganda

Barbara Castelnuovo, Agnes Kiragga, Moses R. Kamya, Yukari C Manabe

Research output: Contribution to journalArticle

Abstract

Purpose: In resource-limited settings, there are only a few antiretroviral treatment (ART) options. Our objective was to evaluate the reasons for first-line ART changes in resource-limited settings. Methods: Prospective research cohort of patients initiating ART between April 2004 and April 2005 in Kampala, Uganda. The main endpoint was the substitution of at least 1 drug included in the initial combination. Results: Five hundred Fifty-nine patients initiated on ART, 70% were female, median CD4+ count 98 (21-163) cells per microliter, median HIV RNA log10 5.4 (5.0-5.8). 413 (74%) patients were started on stavudine, lamivudine, and nevirapine, and 146 (36%) on zidovudine, lamivudine and efavirenz. One hundred Forty-eight (26.5%) had at least one treatment change (incidence rate 14.3 per 100 person-years; confidence interval: 12.2 to 16.9). The main reason for first treatment change was drug toxicity (n = 91, 61.5%). Stavudine accounted for the majority of the toxicities that led to drug substitution (n = 76, 84%). In the multivariate analysis, being female (P = 0.011) and being stage 3-4 as compared with 1-2 at ART initiation were predictive of stavudine substitution (P = 0.05). There was no difference in virologic outcome in patients who changed due to toxicity compared with those who did not. Conclusions: The majority of the treatment changes were due to stavudine-related toxicity. Long-term stavudine use is less well tolerated in women.

Original languageEnglish (US)
Pages (from-to)59-63
Number of pages5
JournalJournal of Acquired Immune Deficiency Syndromes
Volume56
Issue number1
DOIs
StatePublished - Jan 1 2011

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Stavudine
Uganda
efavirenz
Therapeutics
Drug Substitution
Lamivudine
Zidovudine
CD4 Lymphocyte Count
Drug-Related Side Effects and Adverse Reactions
Multivariate Analysis
HIV
RNA
Confidence Intervals
Incidence

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

@article{89005d7d220a411a83b5ae0d90e2e8b6,
title = "Stavudine toxicity in women is the main reason for treatment change in a 3-year prospective cohort of adult patients started on first-line antiretroviral treatment in Uganda",
abstract = "Purpose: In resource-limited settings, there are only a few antiretroviral treatment (ART) options. Our objective was to evaluate the reasons for first-line ART changes in resource-limited settings. Methods: Prospective research cohort of patients initiating ART between April 2004 and April 2005 in Kampala, Uganda. The main endpoint was the substitution of at least 1 drug included in the initial combination. Results: Five hundred Fifty-nine patients initiated on ART, 70{\%} were female, median CD4+ count 98 (21-163) cells per microliter, median HIV RNA log10 5.4 (5.0-5.8). 413 (74{\%}) patients were started on stavudine, lamivudine, and nevirapine, and 146 (36{\%}) on zidovudine, lamivudine and efavirenz. One hundred Forty-eight (26.5{\%}) had at least one treatment change (incidence rate 14.3 per 100 person-years; confidence interval: 12.2 to 16.9). The main reason for first treatment change was drug toxicity (n = 91, 61.5{\%}). Stavudine accounted for the majority of the toxicities that led to drug substitution (n = 76, 84{\%}). In the multivariate analysis, being female (P = 0.011) and being stage 3-4 as compared with 1-2 at ART initiation were predictive of stavudine substitution (P = 0.05). There was no difference in virologic outcome in patients who changed due to toxicity compared with those who did not. Conclusions: The majority of the treatment changes were due to stavudine-related toxicity. Long-term stavudine use is less well tolerated in women.",
author = "Barbara Castelnuovo and Agnes Kiragga and Kamya, {Moses R.} and Manabe, {Yukari C}",
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T1 - Stavudine toxicity in women is the main reason for treatment change in a 3-year prospective cohort of adult patients started on first-line antiretroviral treatment in Uganda

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AU - Kiragga, Agnes

AU - Kamya, Moses R.

AU - Manabe, Yukari C

PY - 2011/1/1

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N2 - Purpose: In resource-limited settings, there are only a few antiretroviral treatment (ART) options. Our objective was to evaluate the reasons for first-line ART changes in resource-limited settings. Methods: Prospective research cohort of patients initiating ART between April 2004 and April 2005 in Kampala, Uganda. The main endpoint was the substitution of at least 1 drug included in the initial combination. Results: Five hundred Fifty-nine patients initiated on ART, 70% were female, median CD4+ count 98 (21-163) cells per microliter, median HIV RNA log10 5.4 (5.0-5.8). 413 (74%) patients were started on stavudine, lamivudine, and nevirapine, and 146 (36%) on zidovudine, lamivudine and efavirenz. One hundred Forty-eight (26.5%) had at least one treatment change (incidence rate 14.3 per 100 person-years; confidence interval: 12.2 to 16.9). The main reason for first treatment change was drug toxicity (n = 91, 61.5%). Stavudine accounted for the majority of the toxicities that led to drug substitution (n = 76, 84%). In the multivariate analysis, being female (P = 0.011) and being stage 3-4 as compared with 1-2 at ART initiation were predictive of stavudine substitution (P = 0.05). There was no difference in virologic outcome in patients who changed due to toxicity compared with those who did not. Conclusions: The majority of the treatment changes were due to stavudine-related toxicity. Long-term stavudine use is less well tolerated in women.

AB - Purpose: In resource-limited settings, there are only a few antiretroviral treatment (ART) options. Our objective was to evaluate the reasons for first-line ART changes in resource-limited settings. Methods: Prospective research cohort of patients initiating ART between April 2004 and April 2005 in Kampala, Uganda. The main endpoint was the substitution of at least 1 drug included in the initial combination. Results: Five hundred Fifty-nine patients initiated on ART, 70% were female, median CD4+ count 98 (21-163) cells per microliter, median HIV RNA log10 5.4 (5.0-5.8). 413 (74%) patients were started on stavudine, lamivudine, and nevirapine, and 146 (36%) on zidovudine, lamivudine and efavirenz. One hundred Forty-eight (26.5%) had at least one treatment change (incidence rate 14.3 per 100 person-years; confidence interval: 12.2 to 16.9). The main reason for first treatment change was drug toxicity (n = 91, 61.5%). Stavudine accounted for the majority of the toxicities that led to drug substitution (n = 76, 84%). In the multivariate analysis, being female (P = 0.011) and being stage 3-4 as compared with 1-2 at ART initiation were predictive of stavudine substitution (P = 0.05). There was no difference in virologic outcome in patients who changed due to toxicity compared with those who did not. Conclusions: The majority of the treatment changes were due to stavudine-related toxicity. Long-term stavudine use is less well tolerated in women.

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