Limits...
Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir.

Smith C, Weinberg A, Forster JE, Levin MJ, Davies J, Pappas J, Kinzie K, Barr E, Paul S, McFarland EJ - Infect Dis Obstet Gynecol (2016)

Bottom Line: Combination antiretroviral therapy (cART) is successfully used for prevention of perinatal HIV transmission.In conclusion, hematologic and hepatic AE were frequent, but rarely serious.In this predominantly protease inhibitor-treated population, lopinavir/ritonavir was associated with the lowest rate of infant AE.

View Article: PubMed Central - PubMed

Affiliation: Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO 80045, USA.

ABSTRACT
Combination antiretroviral therapy (cART) is successfully used for prevention of perinatal HIV transmission. To investigate safety, we compared adverse events (AE) among infants exposed to different maternal cART regimens. We reviewed 158 HIV-uninfected infants born between 1997 and 2009, using logistic regression to model grade ≥1 AE and grade ≥3 AE as a function of maternal cART and confounding variables (preterm, C-section, illicit drug use, race, ethnicity, infant antiretrovirals, and maternal viremia). Frequently used cART regimens included zidovudine (63%), lamivudine (80%), ritonavir-boosted lopinavir (37%), nelfinavir (26%), and atazanavir (10%). At birth, anemia occurred in 13/140 infants (9%), neutropenia in 27/107 (25%), thrombocytopenia in 5/133 (4%), and liver enzyme elevation in 21/130 (16%). Corresponding rates of AE at 4 weeks were 59/141 (42%), 54/130 (42%), 3/137 (2%), and 3/104 (3%), respectively. Serious AE (grade ≥ 3) exceeded 2% only for neutropenia (13% at birth; 9% at 4 weeks). Compared with infants exposed to maternal lopinavir/ritonavir, infants exposed to nelfinavir and atazanavir had a 5-fold and 4-fold higher incidence of AE at birth, respectively. In conclusion, hematologic and hepatic AE were frequent, but rarely serious. In this predominantly protease inhibitor-treated population, lopinavir/ritonavir was associated with the lowest rate of infant AE.

No MeSH data available.


Related in: MedlinePlus

Frequency of infant adverse events. Bars represent percentages of infants with laboratory adverse events at birth (age 0–7 days) and at 4 weeks (±2 weeks). Hgb, hemoglobin; ANC, absolute neutrophil count; plts, platelet count; AST, aspartate aminotransferase; ALT, alanine aminotransferase.
© Copyright Policy - open-access
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4834394&req=5

fig1: Frequency of infant adverse events. Bars represent percentages of infants with laboratory adverse events at birth (age 0–7 days) and at 4 weeks (±2 weeks). Hgb, hemoglobin; ANC, absolute neutrophil count; plts, platelet count; AST, aspartate aminotransferase; ALT, alanine aminotransferase.

Mentions: Laboratory AE in the first four weeks of life were common, with three quarters of infants having an AE (any grade) at either birth or 4 weeks. The frequency of an AE grade ≥3 in any laboratory category was 12% at birth and 16% at 4 weeks. Neutropenia was most common, with 25% and 42% of infants having any grade AE, and 13% and 9% having grade ≥3 AE, at birth and 4 weeks, respectively (Figure 1). Anemia was the next most common, with 9% and 42% of infants having any grade AE, but only 1% and 0% having grade ≥3 AE, at birth and 4 weeks, respectively. Rates of AST AE fell from 16% at birth to 3% at 4 weeks. Rates of ALT AE and thrombocytopenia were low at birth and at 4 weeks. No infants had hyperbilirubinemia at birth.


Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir.

Smith C, Weinberg A, Forster JE, Levin MJ, Davies J, Pappas J, Kinzie K, Barr E, Paul S, McFarland EJ - Infect Dis Obstet Gynecol (2016)

Frequency of infant adverse events. Bars represent percentages of infants with laboratory adverse events at birth (age 0–7 days) and at 4 weeks (±2 weeks). Hgb, hemoglobin; ANC, absolute neutrophil count; plts, platelet count; AST, aspartate aminotransferase; ALT, alanine aminotransferase.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4834394&req=5

fig1: Frequency of infant adverse events. Bars represent percentages of infants with laboratory adverse events at birth (age 0–7 days) and at 4 weeks (±2 weeks). Hgb, hemoglobin; ANC, absolute neutrophil count; plts, platelet count; AST, aspartate aminotransferase; ALT, alanine aminotransferase.
Mentions: Laboratory AE in the first four weeks of life were common, with three quarters of infants having an AE (any grade) at either birth or 4 weeks. The frequency of an AE grade ≥3 in any laboratory category was 12% at birth and 16% at 4 weeks. Neutropenia was most common, with 25% and 42% of infants having any grade AE, and 13% and 9% having grade ≥3 AE, at birth and 4 weeks, respectively (Figure 1). Anemia was the next most common, with 9% and 42% of infants having any grade AE, but only 1% and 0% having grade ≥3 AE, at birth and 4 weeks, respectively. Rates of AST AE fell from 16% at birth to 3% at 4 weeks. Rates of ALT AE and thrombocytopenia were low at birth and at 4 weeks. No infants had hyperbilirubinemia at birth.

Bottom Line: Combination antiretroviral therapy (cART) is successfully used for prevention of perinatal HIV transmission.In conclusion, hematologic and hepatic AE were frequent, but rarely serious.In this predominantly protease inhibitor-treated population, lopinavir/ritonavir was associated with the lowest rate of infant AE.

View Article: PubMed Central - PubMed

Affiliation: Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO 80045, USA.

ABSTRACT
Combination antiretroviral therapy (cART) is successfully used for prevention of perinatal HIV transmission. To investigate safety, we compared adverse events (AE) among infants exposed to different maternal cART regimens. We reviewed 158 HIV-uninfected infants born between 1997 and 2009, using logistic regression to model grade ≥1 AE and grade ≥3 AE as a function of maternal cART and confounding variables (preterm, C-section, illicit drug use, race, ethnicity, infant antiretrovirals, and maternal viremia). Frequently used cART regimens included zidovudine (63%), lamivudine (80%), ritonavir-boosted lopinavir (37%), nelfinavir (26%), and atazanavir (10%). At birth, anemia occurred in 13/140 infants (9%), neutropenia in 27/107 (25%), thrombocytopenia in 5/133 (4%), and liver enzyme elevation in 21/130 (16%). Corresponding rates of AE at 4 weeks were 59/141 (42%), 54/130 (42%), 3/137 (2%), and 3/104 (3%), respectively. Serious AE (grade ≥ 3) exceeded 2% only for neutropenia (13% at birth; 9% at 4 weeks). Compared with infants exposed to maternal lopinavir/ritonavir, infants exposed to nelfinavir and atazanavir had a 5-fold and 4-fold higher incidence of AE at birth, respectively. In conclusion, hematologic and hepatic AE were frequent, but rarely serious. In this predominantly protease inhibitor-treated population, lopinavir/ritonavir was associated with the lowest rate of infant AE.

No MeSH data available.


Related in: MedlinePlus