Effect of HIV-1 antiretroviral prophylaxis on hepatic and hematological parameters of African infants

Taha E Taha, Newton Kumwenda, Amanda Gibbons, Donald Hoover, Valentino Lema, Susan Fiscus, Joshua Mukiibi, George Liomba, Robin Broadhead

Research output: Contribution to journalArticle

Abstract

Objective: To measure hepatic and hematological parameters among neonates randomized to receive ultra-short antiretroviral regimens. Design: As part of an on-going clinical trial in Malawi, infants born to women who received (early presenters) or did not receive (late presenters) standard intrapartum nevirapine (NVP) dosing were randomized to receive orally either single dose NVP alone or NVP plus zidovudine (twice daily for 1 week). An additional group of untreated infants (born to HIV-uninfected women) was enrolled as a control. Methods: Laboratory measurements were performed at birth and repeated at 6 weeks of age. Serum alanine aminotransferase (ALT) was measured on approximately 200 infants consecutively enrolled and randomized at the start of the trial. Complete blood count (CBC) was performed on approximately 800 infants at birth and 600 infants at 6 weeks of age. ALT and CBC were also determined on approximately 200 control infants. Results: At birth there were no differences in ALT values between the groups of children. At 6 weeks of age, ALT levels were significantly higher among the treated groups compared with control group (geometric mean of 11.5 U/l for controls and 16.2-19.1 U/l for treated groups; P <0.0001). Hematological parameters did not differ between groups at birth. At 6 weeks of age, levels of hemoglobin, hematocrit, granulocytes, and platelets were significantly (P <0.0001) lower among antiviral drug-treated groups compared with controls. These changes were consistent with grade 1 (mild) toxicity, and were more noticeable among HIV-infected infants. Conclusions: Hepatic and hematologic abnormalities associated with short-term neonatal antiretrovirals among African children are minimal.

Original languageEnglish (US)
Pages (from-to)851-858
Number of pages8
JournalAIDS
Volume16
Issue number6
DOIs
StatePublished - Apr 12 2002

Fingerprint

HIV-1
Alanine Transaminase
Liver
Nevirapine
Parturition
Blood Cell Count
HIV
Malawi
Zidovudine
Hematocrit
Granulocytes
Antiviral Agents
Hemoglobins
Blood Platelets
Clinical Trials
Newborn Infant
Control Groups
Serum

Keywords

  • Alanine aminotransferase
  • Antiretroviral drugs
  • Hematological parameters
  • Post-exposure prophylaxis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Effect of HIV-1 antiretroviral prophylaxis on hepatic and hematological parameters of African infants. / Taha, Taha E; Kumwenda, Newton; Gibbons, Amanda; Hoover, Donald; Lema, Valentino; Fiscus, Susan; Mukiibi, Joshua; Liomba, George; Broadhead, Robin.

In: AIDS, Vol. 16, No. 6, 12.04.2002, p. 851-858.

Research output: Contribution to journalArticle

Taha, TE, Kumwenda, N, Gibbons, A, Hoover, D, Lema, V, Fiscus, S, Mukiibi, J, Liomba, G & Broadhead, R 2002, 'Effect of HIV-1 antiretroviral prophylaxis on hepatic and hematological parameters of African infants', AIDS, vol. 16, no. 6, pp. 851-858. https://doi.org/10.1097/00002030-200204120-00004
Taha, Taha E ; Kumwenda, Newton ; Gibbons, Amanda ; Hoover, Donald ; Lema, Valentino ; Fiscus, Susan ; Mukiibi, Joshua ; Liomba, George ; Broadhead, Robin. / Effect of HIV-1 antiretroviral prophylaxis on hepatic and hematological parameters of African infants. In: AIDS. 2002 ; Vol. 16, No. 6. pp. 851-858.
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AU - Taha, Taha E

AU - Kumwenda, Newton

AU - Gibbons, Amanda

AU - Hoover, Donald

AU - Lema, Valentino

AU - Fiscus, Susan

AU - Mukiibi, Joshua

AU - Liomba, George

AU - Broadhead, Robin

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N2 - Objective: To measure hepatic and hematological parameters among neonates randomized to receive ultra-short antiretroviral regimens. Design: As part of an on-going clinical trial in Malawi, infants born to women who received (early presenters) or did not receive (late presenters) standard intrapartum nevirapine (NVP) dosing were randomized to receive orally either single dose NVP alone or NVP plus zidovudine (twice daily for 1 week). An additional group of untreated infants (born to HIV-uninfected women) was enrolled as a control. Methods: Laboratory measurements were performed at birth and repeated at 6 weeks of age. Serum alanine aminotransferase (ALT) was measured on approximately 200 infants consecutively enrolled and randomized at the start of the trial. Complete blood count (CBC) was performed on approximately 800 infants at birth and 600 infants at 6 weeks of age. ALT and CBC were also determined on approximately 200 control infants. Results: At birth there were no differences in ALT values between the groups of children. At 6 weeks of age, ALT levels were significantly higher among the treated groups compared with control group (geometric mean of 11.5 U/l for controls and 16.2-19.1 U/l for treated groups; P <0.0001). Hematological parameters did not differ between groups at birth. At 6 weeks of age, levels of hemoglobin, hematocrit, granulocytes, and platelets were significantly (P <0.0001) lower among antiviral drug-treated groups compared with controls. These changes were consistent with grade 1 (mild) toxicity, and were more noticeable among HIV-infected infants. Conclusions: Hepatic and hematologic abnormalities associated with short-term neonatal antiretrovirals among African children are minimal.

AB - Objective: To measure hepatic and hematological parameters among neonates randomized to receive ultra-short antiretroviral regimens. Design: As part of an on-going clinical trial in Malawi, infants born to women who received (early presenters) or did not receive (late presenters) standard intrapartum nevirapine (NVP) dosing were randomized to receive orally either single dose NVP alone or NVP plus zidovudine (twice daily for 1 week). An additional group of untreated infants (born to HIV-uninfected women) was enrolled as a control. Methods: Laboratory measurements were performed at birth and repeated at 6 weeks of age. Serum alanine aminotransferase (ALT) was measured on approximately 200 infants consecutively enrolled and randomized at the start of the trial. Complete blood count (CBC) was performed on approximately 800 infants at birth and 600 infants at 6 weeks of age. ALT and CBC were also determined on approximately 200 control infants. Results: At birth there were no differences in ALT values between the groups of children. At 6 weeks of age, ALT levels were significantly higher among the treated groups compared with control group (geometric mean of 11.5 U/l for controls and 16.2-19.1 U/l for treated groups; P <0.0001). Hematological parameters did not differ between groups at birth. At 6 weeks of age, levels of hemoglobin, hematocrit, granulocytes, and platelets were significantly (P <0.0001) lower among antiviral drug-treated groups compared with controls. These changes were consistent with grade 1 (mild) toxicity, and were more noticeable among HIV-infected infants. Conclusions: Hepatic and hematologic abnormalities associated with short-term neonatal antiretrovirals among African children are minimal.

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KW - Hematological parameters

KW - Post-exposure prophylaxis

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