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Baseline severe anaemia should not preclude use of zidovudine in antiretroviral-eligible patients in resource-limited settings.

Kiragga AN, Castelnuovo B, Nakanjako D, Manabe YC - J Int AIDS Soc (2010)

Bottom Line: Patients with baseline anaemia had a larger increase in Hb (median g/dL [IQR]) within the first six months compared with non-anaemic patients (2.9 [1.7, 4.6] vs. 0.7 [-0.2, 1.7], p < 0.0001).Initiation on a zidovudine-based regimen was not associated with an increased risk of early severe anaemia.These data suggest that baseline severe anaemia should not be used as a criterion for avoiding the use of zidovudine in patients initiating ART in resource-limited settings.

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Affiliation: Infectious Diseases Institute, Makerere University, Kampala, Uganda.

ABSTRACT

Background: Stavudine is no longer recommended as part of first-line therapy for patients initiating antiretroviral therapy (ART) in Uganda. Most patients are currently initiated on zidovudine-containing regimens, which can induce anaemia. We investigated the risk factors for early severe anaemia in the first six months of ART initiation.

Methods: We defined baseline (ART initiation) anaemia as haemoglobin (Hb) ≤9.5 g/dL, baseline severe anaemia as Hb ≤8 g/dL, and early severe anaemia as Hb ≤8 g/dL within six months of ART initiation. Risk factors for the development of early severe anaemia were analyzed using a multivariable logistic regression model.

Results: In total, 5494 patients initiated ART, 821 (15%) had baseline anaemia, and 296 (5%) had baseline severe anaemia. Early severe anaemia occurred in 109 (4%) of 3105 patients who had at least one Hb measurement in the first six months on ART. Patients with baseline anaemia had a larger increase in Hb (median g/dL [IQR]) within the first six months compared with non-anaemic patients (2.9 [1.7, 4.6] vs. 0.7 [-0.2, 1.7], p < 0.0001). Having a new tuberculosis episode OR 3.69 (95% CI 1.64 - 8.32), MCV <80fL OR 1.60 (95% CI 1.01- 2.52) and baseline severe anaemia OR 5.27 (95% CI 3.00 - 9.26) were associated with early severe anaemia. Initiation on a zidovudine-based regimen was not associated with an increased risk of early severe anaemia.

Conclusions: Among patients in an urban HIV clinic in Uganda, severe anaemia is modestly prevalent at ART initiation and improves with ART in the majority of patients. These data suggest that baseline severe anaemia should not be used as a criterion for avoiding the use of zidovudine in patients initiating ART in resource-limited settings.

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Proportion discontinuing a d4T- or AZT- based regimen with six months of ART initiation. Patients who were initiated on an AZT-containing regimen (n = 2230) are denoted with a dotted line; those initially on d4T-containing regimen (n = 3264) are denoted with a dashed line.
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Figure 2: Proportion discontinuing a d4T- or AZT- based regimen with six months of ART initiation. Patients who were initiated on an AZT-containing regimen (n = 2230) are denoted with a dotted line; those initially on d4T-containing regimen (n = 3264) are denoted with a dashed line.

Mentions: In the first six months, changes were made to the regimens of 134 patients; the switch rate per 100 person years at risk was 3.5 (95% CI 2.9 - 4.1). Overall, the rate per 100 person years at risk of regimen switching across baseline regimen (d4T vs. AZT) was not different (3.32 (95% CI 2.65 - 4.17) vs. 3.69 (95% CI 2.85 - 4.77), p = 0.749 (Figure 2). Switching due to toxicities was the main reason for treatment change in the first six months after initiation, occurring in 82 (61.2%) of 134; only one patient with baseline severe anaemia who began on an AZT-containing regimen had a regimen switch because of persistent or worsened anaemia.


Baseline severe anaemia should not preclude use of zidovudine in antiretroviral-eligible patients in resource-limited settings.

Kiragga AN, Castelnuovo B, Nakanjako D, Manabe YC - J Int AIDS Soc (2010)

Proportion discontinuing a d4T- or AZT- based regimen with six months of ART initiation. Patients who were initiated on an AZT-containing regimen (n = 2230) are denoted with a dotted line; those initially on d4T-containing regimen (n = 3264) are denoted with a dashed line.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2991285&req=5

Figure 2: Proportion discontinuing a d4T- or AZT- based regimen with six months of ART initiation. Patients who were initiated on an AZT-containing regimen (n = 2230) are denoted with a dotted line; those initially on d4T-containing regimen (n = 3264) are denoted with a dashed line.
Mentions: In the first six months, changes were made to the regimens of 134 patients; the switch rate per 100 person years at risk was 3.5 (95% CI 2.9 - 4.1). Overall, the rate per 100 person years at risk of regimen switching across baseline regimen (d4T vs. AZT) was not different (3.32 (95% CI 2.65 - 4.17) vs. 3.69 (95% CI 2.85 - 4.77), p = 0.749 (Figure 2). Switching due to toxicities was the main reason for treatment change in the first six months after initiation, occurring in 82 (61.2%) of 134; only one patient with baseline severe anaemia who began on an AZT-containing regimen had a regimen switch because of persistent or worsened anaemia.

Bottom Line: Patients with baseline anaemia had a larger increase in Hb (median g/dL [IQR]) within the first six months compared with non-anaemic patients (2.9 [1.7, 4.6] vs. 0.7 [-0.2, 1.7], p < 0.0001).Initiation on a zidovudine-based regimen was not associated with an increased risk of early severe anaemia.These data suggest that baseline severe anaemia should not be used as a criterion for avoiding the use of zidovudine in patients initiating ART in resource-limited settings.

View Article: PubMed Central - HTML - PubMed

Affiliation: Infectious Diseases Institute, Makerere University, Kampala, Uganda.

ABSTRACT

Background: Stavudine is no longer recommended as part of first-line therapy for patients initiating antiretroviral therapy (ART) in Uganda. Most patients are currently initiated on zidovudine-containing regimens, which can induce anaemia. We investigated the risk factors for early severe anaemia in the first six months of ART initiation.

Methods: We defined baseline (ART initiation) anaemia as haemoglobin (Hb) ≤9.5 g/dL, baseline severe anaemia as Hb ≤8 g/dL, and early severe anaemia as Hb ≤8 g/dL within six months of ART initiation. Risk factors for the development of early severe anaemia were analyzed using a multivariable logistic regression model.

Results: In total, 5494 patients initiated ART, 821 (15%) had baseline anaemia, and 296 (5%) had baseline severe anaemia. Early severe anaemia occurred in 109 (4%) of 3105 patients who had at least one Hb measurement in the first six months on ART. Patients with baseline anaemia had a larger increase in Hb (median g/dL [IQR]) within the first six months compared with non-anaemic patients (2.9 [1.7, 4.6] vs. 0.7 [-0.2, 1.7], p < 0.0001). Having a new tuberculosis episode OR 3.69 (95% CI 1.64 - 8.32), MCV <80fL OR 1.60 (95% CI 1.01- 2.52) and baseline severe anaemia OR 5.27 (95% CI 3.00 - 9.26) were associated with early severe anaemia. Initiation on a zidovudine-based regimen was not associated with an increased risk of early severe anaemia.

Conclusions: Among patients in an urban HIV clinic in Uganda, severe anaemia is modestly prevalent at ART initiation and improves with ART in the majority of patients. These data suggest that baseline severe anaemia should not be used as a criterion for avoiding the use of zidovudine in patients initiating ART in resource-limited settings.

Show MeSH
Related in: MedlinePlus