Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities
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 rece...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2011-05-01
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| Series: | Brazilian Journal of Infectious Diseases |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1413867011701854 |
| _version_ | 1818405755890434048 |
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| author | Mario Ferreira Peixoto, M.D. José Henrique Pilotto, M.D., Ph.D. Sonia Karolina Stoszek, Ph.D. Regis Kreitchmann, M.D. Marisa Márcia Mussi-Pinhata, M.D. Victor Hugo Melo, M.D. Esaú Custodio João, M.D. Mariana Ceriotto, M.D. Ricardo da Silva de Souza, M.D. Jennifer Read, M.D. |
| author_facet | Mario Ferreira Peixoto, M.D. José Henrique Pilotto, M.D., Ph.D. Sonia Karolina Stoszek, Ph.D. Regis Kreitchmann, M.D. Marisa Márcia Mussi-Pinhata, M.D. Victor Hugo Melo, M.D. Esaú Custodio João, M.D. Mariana Ceriotto, M.D. Ricardo da Silva de Souza, M.D. Jennifer Read, M.D. |
| author_sort | Mario Ferreira Peixoto, M.D. |
| collection | DOAJ |
| description | 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. Keywords: pregnancy, HIV, HIV protease inhibitors, drug toxicity |
| first_indexed | 2024-12-14T09:01:06Z |
| format | Article |
| id | doaj.art-871566108a4e46668b687fa9127e7af0 |
| institution | Directory Open Access Journal |
| issn | 1413-8670 |
| language | English |
| last_indexed | 2024-12-14T09:01:06Z |
| publishDate | 2011-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Brazilian Journal of Infectious Diseases |
| spelling | doaj.art-871566108a4e46668b687fa9127e7af02022-12-21T23:08:48ZengElsevierBrazilian Journal of Infectious Diseases1413-86702011-05-01153253261Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalitiesMario Ferreira Peixoto, M.D.0José Henrique Pilotto, M.D., Ph.D.1Sonia Karolina Stoszek, Ph.D.2Regis Kreitchmann, M.D.3Marisa Márcia Mussi-Pinhata, M.D.4Victor Hugo Melo, M.D.5Esaú Custodio João, M.D.6Mariana Ceriotto, M.D.7Ricardo da Silva de Souza, M.D.8Jennifer Read, M.D.9Unidade de Prevenção à Transmissão Vertical, Hospital Femina: Porto Alegre, Rio Grande do Sul, Brazil; Mario Ferreira Peixoto Serviço de Infectologia Rua Mostardeiro, 17/ 4° andar Porto Alegre, RS, Brazil - 90430-000.Hospital Geral de Nova Iguaçu; Laboratório de AIDS e Imunologia Molecular - IOC/ Fiocruz, Rio de Janeiro, BrazilWestat; Rockville, Maryland, USAIrmandade da Santa Casa de Misericórdia de Porto Alegre: Porto Alegre, Rio Grande do Sul, BrazilFaculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, BrazilUniversidade Federal de Minas Gerais, Belo Horizonte, MG, BrazilHospital dos Servidores do Estado, Rio de Janeiro, BrazilHospital de Agudos Dra. Cecilia Grierson, Buenos Aires, ArgentinaUniversidade de Caxias do Sul, STD/HIV Clinic, Rio Grande do Sul, BrazilPediatric, Adolescent, and Maternal AIDS Branch; CRMCNICHD- NIH; Bethesda, Maryland, USAObjectives: 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. Keywords: pregnancy, HIV, HIV protease inhibitors, drug toxicityhttp://www.sciencedirect.com/science/article/pii/S1413867011701854 |
| spellingShingle | Mario Ferreira Peixoto, M.D. José Henrique Pilotto, M.D., Ph.D. Sonia Karolina Stoszek, Ph.D. Regis Kreitchmann, M.D. Marisa Márcia Mussi-Pinhata, M.D. Victor Hugo Melo, M.D. Esaú Custodio João, M.D. Mariana Ceriotto, M.D. Ricardo da Silva de Souza, M.D. Jennifer Read, M.D. Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities Brazilian Journal of Infectious Diseases |
| title | Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities |
| title_full | Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities |
| title_fullStr | Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities |
| title_full_unstemmed | Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities |
| title_short | Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities |
| title_sort | lopinavir ritonavir dosing during pregnancy in brazil and maternal infant laboratory abnormalities |
| url | http://www.sciencedirect.com/science/article/pii/S1413867011701854 |
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