Abstract
Background: Practical issues, including cost, hinder implementing virologic monitoring of patients on antiretroviral therapy (ART) in resource-limited settings. We evaluated factors that might guide monitoring frequency and efforts to prevent treatment failure after initial virologic suppression. Methods: Participants were the 911 HIV-infected antiretroviral-naïve adults with CD4 count <300 cells/μL who started efavirenz-based ART in the international A5175/PEARLS trial and achieved HIV-1 RNA <1000 copies/mL at 24 weeks. Participant report of ART adherence was evaluated using a structured questionnaire in monthly interviews. Adherence and readily available clinical and laboratory measures were evaluated as predictors of late virologic failure (late VF: confirmed HIV-1 RNA ≥1000 copies/mL after 24 weeks). Results: During median follow-up of 3.5 years, 82/911 participants (9%) experienced late VF. Of 516 participants reporting missed doses during the first 24 weeks of ART, 55 (11%) experienced late VF, compared with 27 (7%) of 395 participants reporting no missed doses (hazard ratio: 1.73; 95% CI: 1.08, 2.73). This difference persisted in multivariable analysis, in which lower pre-ART hemoglobin and absence of Grade ≥3 laboratory results prior to week 24 were also associated with higher risk of late VF. Discussion: In this clinical trial, the late VF rate after successful suppression was very low. If achievable in routine clinical practice, virologic monitoring involving infrequent (e.g. annual) measurements might be considered; the implications of this for development of resistance need evaluating. Patients reporting missed doses early after ART initiation, despite achieving initial suppression, might require more frequent measurement and/or strategies for promoting adherence.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 173-180 |
| Number of pages | 8 |
| Journal | HIV Clinical Trials |
| Volume | 17 |
| Issue number | 5 |
| DOIs | |
| State | Published - Sep 2 2016 |
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Keywords
- Adherence
- Antiretroviral therapy
- Resource-limited settings
- Viral load monitoring
- Virologic failure
- Virologic suppression
ASJC Scopus subject areas
- Medicine(all)
- Infectious Diseases
- Pharmacology (medical)
Cite this
Predictors of late virologic failure after initial successful suppression of HIV replication on efavirenz-based antiretroviral therapy. / ACTG A5175/PEARLS Study Team.
In: HIV Clinical Trials, Vol. 17, No. 5, 02.09.2016, p. 173-180.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Predictors of late virologic failure after initial successful suppression of HIV replication on efavirenz-based antiretroviral therapy
AU - ACTG A5175/PEARLS Study Team
AU - Singini, Isaac
AU - Campbell, Thomas B.
AU - Smeaton, Laura M.
AU - Kumarasamy, Nagalingeswaran
AU - La Rosa, Alberto
AU - Taejareonkul, Sineenart
AU - Safren, Steven
AU - Flanigan, Timothy P.
AU - Hakim, James G.
AU - Hughes, Michael D.
PY - 2016/9/2
Y1 - 2016/9/2
N2 - Background: Practical issues, including cost, hinder implementing virologic monitoring of patients on antiretroviral therapy (ART) in resource-limited settings. We evaluated factors that might guide monitoring frequency and efforts to prevent treatment failure after initial virologic suppression. Methods: Participants were the 911 HIV-infected antiretroviral-naïve adults with CD4 count <300 cells/μL who started efavirenz-based ART in the international A5175/PEARLS trial and achieved HIV-1 RNA <1000 copies/mL at 24 weeks. Participant report of ART adherence was evaluated using a structured questionnaire in monthly interviews. Adherence and readily available clinical and laboratory measures were evaluated as predictors of late virologic failure (late VF: confirmed HIV-1 RNA ≥1000 copies/mL after 24 weeks). Results: During median follow-up of 3.5 years, 82/911 participants (9%) experienced late VF. Of 516 participants reporting missed doses during the first 24 weeks of ART, 55 (11%) experienced late VF, compared with 27 (7%) of 395 participants reporting no missed doses (hazard ratio: 1.73; 95% CI: 1.08, 2.73). This difference persisted in multivariable analysis, in which lower pre-ART hemoglobin and absence of Grade ≥3 laboratory results prior to week 24 were also associated with higher risk of late VF. Discussion: In this clinical trial, the late VF rate after successful suppression was very low. If achievable in routine clinical practice, virologic monitoring involving infrequent (e.g. annual) measurements might be considered; the implications of this for development of resistance need evaluating. Patients reporting missed doses early after ART initiation, despite achieving initial suppression, might require more frequent measurement and/or strategies for promoting adherence.
AB - Background: Practical issues, including cost, hinder implementing virologic monitoring of patients on antiretroviral therapy (ART) in resource-limited settings. We evaluated factors that might guide monitoring frequency and efforts to prevent treatment failure after initial virologic suppression. Methods: Participants were the 911 HIV-infected antiretroviral-naïve adults with CD4 count <300 cells/μL who started efavirenz-based ART in the international A5175/PEARLS trial and achieved HIV-1 RNA <1000 copies/mL at 24 weeks. Participant report of ART adherence was evaluated using a structured questionnaire in monthly interviews. Adherence and readily available clinical and laboratory measures were evaluated as predictors of late virologic failure (late VF: confirmed HIV-1 RNA ≥1000 copies/mL after 24 weeks). Results: During median follow-up of 3.5 years, 82/911 participants (9%) experienced late VF. Of 516 participants reporting missed doses during the first 24 weeks of ART, 55 (11%) experienced late VF, compared with 27 (7%) of 395 participants reporting no missed doses (hazard ratio: 1.73; 95% CI: 1.08, 2.73). This difference persisted in multivariable analysis, in which lower pre-ART hemoglobin and absence of Grade ≥3 laboratory results prior to week 24 were also associated with higher risk of late VF. Discussion: In this clinical trial, the late VF rate after successful suppression was very low. If achievable in routine clinical practice, virologic monitoring involving infrequent (e.g. annual) measurements might be considered; the implications of this for development of resistance need evaluating. Patients reporting missed doses early after ART initiation, despite achieving initial suppression, might require more frequent measurement and/or strategies for promoting adherence.
KW - Adherence
KW - Antiretroviral therapy
KW - Resource-limited settings
KW - Viral load monitoring
KW - Virologic failure
KW - Virologic suppression
UR - http://www.scopus.com/inward/record.url?scp=84979993844&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84979993844&partnerID=8YFLogxK
U2 - 10.1080/15284336.2016.1201300
DO - 10.1080/15284336.2016.1201300
M3 - Article
AN - SCOPUS:84979993844
VL - 17
SP - 173
EP - 180
JO - HIV Clinical Trials
JF - HIV Clinical Trials
SN - 1528-4336
IS - 5
ER -