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LOPINAVIR/RITONAVIR DOSING DURING PREGNANCY IN BRAZIL AND MATERNAL/INFANT LABORATORY ABNORMALITIES
Author
Affilliation
Hospital Femina. Unidade de Prevenção à Transmissão Vertical. Porto Alegre, RS, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil / Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil.
Westat. Rockville, Maryland, USA.
Irmandade da Santa Casa de Misericórdia de Porto Alegre. Porto Alegre, RS, Brasil.
Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Ribeirão Preto, SP, Brasil.
Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brasil.
Hospital dos Servidores do Estado. Rio de Janeiro, RJ, Brasil.
Hospital de Agudos Dra. Cecilia Grierson. Buenos Aires, Argentina.
Universidade de Caxias do Sul. STD/HIV Clinic. Rio Grande do Sul, RS, Brasil.
CRMC-NICHD-NIH. Pediatric, Adolescent, and Maternal AIDS Branch. Bethesda, Maryland, USA.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil / Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil.
Westat. Rockville, Maryland, USA.
Irmandade da Santa Casa de Misericórdia de Porto Alegre. Porto Alegre, RS, Brasil.
Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Ribeirão Preto, SP, Brasil.
Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brasil.
Hospital dos Servidores do Estado. Rio de Janeiro, RJ, Brasil.
Hospital de Agudos Dra. Cecilia Grierson. Buenos Aires, Argentina.
Universidade de Caxias do Sul. STD/HIV Clinic. Rio Grande do Sul, RS, Brasil.
CRMC-NICHD-NIH. Pediatric, Adolescent, and Maternal AIDS Branch. Bethesda, Maryland, USA.
Abstract
OBJECTIVES: To describe laboratory abnormalities among HIV-infected women and their infants with standard and increased lopinavir/ritonavir (LPV/r) dosing during the third trimester of pregnancy.
METHODS: We evaluated data on pregnant women from NISDI cohorts (2002-2009) enrolled in Brazil, who received at least 28 days of LPV/r during the third pregnancy trimester and gave birth to singleton infants.
RESULTS: 164 women received LPV/r standard dosing [(798/198 or 800/200 mg/day) (Group 1)] and 70 increased dosing [(> 800/200 mg/day) (Group 2)]. Group 1 was more likely to have advanced clinical disease and to use ARVs for treatment, and less likely to have CD4 counts > 500 cells/mm3. Mean plasma viral load was higher in Group 2. There were statistically significant, but not clinically meaningful, differences between groups in mean AST, ALT, cholesterol, and triglycerides. The proportion of women with Grade 3 or 4 adverse events was very low, with no statistically significant differences between groups in severe adverse events related to ALT, AST, total bilirubin, cholesterol, or triglycerides. There were statistically significant, but not clinically meaningful, differences between infant groups in ALT and creatinine. The proportion of infants with Grade 3 or 4 adverse events was very low, and there were no statistically significant differences in severe adverse events related to ALT, AST, BUN, or creatinine.
CONCLUSION: The proportions of women and infants with severe laboratory adverse events were very low. Increased LPV/r dosing during the third trimester of pregnancy appears to be safe for HIV-infected women and their infants.
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