Safety and Trough Concentrations of Nevirapine Prophylaxis Given Daily, Twice Weekly, or Weekly in Breast-Feeding Infants From Birth to 6 Months
Despite the success of antiretroviral prophylaxis in reducing mother-to-child HIV-1 transmission, postpartum transmission through breast milk remains a problem. Antiretroviral administration to the infant during the period of breast-feeding could protect against postnatal transmission. An open-label...
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| Veröffentlicht in: | Journal of acquired immune deficiency syndromes (1999) 2003-12, Vol.34 (5), p.482-490 |
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| creator | Shetty, Avinash K Coovadia, Hoosen M Mirochnick, Mark M Maldonado, Yvonne Mofenson, Lynne M Eshleman, Susan H Fleming, Thomas Emel, Lynda George, Kathy Katzenstein, David A Wells, Jennifer Maponga, Charles C Mwatha, Anthony Jones, Samuel Adeniyi Abdool Karim, Salim S Bassett, Mary T |
| description | Despite the success of antiretroviral prophylaxis in reducing mother-to-child HIV-1 transmission, postpartum transmission through breast milk remains a problem. Antiretroviral administration to the infant during the period of breast-feeding could protect against postnatal transmission. An open-label phase 1/2 study was designed to assess the safety and trough concentrations of nevirapine (NVP) given once weekly (OW), twice weekly (TW), or once daily (OD) to HIV-exposed breast-feeding infants for 24 weeks. Following maternal dosing with 200 mg NVP orally at onset of labor, breast-feeding infants were randomized within 48 hours of birth to 1 of 3 regimensarm 1, NVP given OW (4 mg/kg from birth to 14 days, ↑ to 8 mg/kg from 15 days to 24 weeks), arm 2, NVP given TW (4 mg/kg from birth to 14 days, ↑ to 8 mg/kg from 15 days to 24 weeks), and arm 3, NVP given OD (2 mg/kg from birth to 14 days, ↑ to 4 mg/kg from 15 days to 24 weeks). Trough NVP concentrations and clinical and laboratory abnormalities were monitored. Of the 75 infants randomized (26 to OW, 25 to TW, and 24 to OD dosing), 63 completed the 32-week follow-up visit. No severe skin, hepatic, or renal toxicity related to NVP was observed. Neutropenia occurred in 8 infants. Trough NVP levels were lower than the therapeutic target (100 ng/mL) in 48 of 75 (64.0%) samples from infants in the OW arm, 3 of 65 (4.6%) samples in the TW arm, and 0 of 72 samples in the OD arm. Median (range) trough NVP concentrations were 64 ng/mL (range |
| doi_str_mv | 10.1097/00126334-200312150-00006 |
| format | Article |
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Antiretroviral administration to the infant during the period of breast-feeding could protect against postnatal transmission. An open-label phase 1/2 study was designed to assess the safety and trough concentrations of nevirapine (NVP) given once weekly (OW), twice weekly (TW), or once daily (OD) to HIV-exposed breast-feeding infants for 24 weeks. Following maternal dosing with 200 mg NVP orally at onset of labor, breast-feeding infants were randomized within 48 hours of birth to 1 of 3 regimensarm 1, NVP given OW (4 mg/kg from birth to 14 days, ↑ to 8 mg/kg from 15 days to 24 weeks), arm 2, NVP given TW (4 mg/kg from birth to 14 days, ↑ to 8 mg/kg from 15 days to 24 weeks), and arm 3, NVP given OD (2 mg/kg from birth to 14 days, ↑ to 4 mg/kg from 15 days to 24 weeks). Trough NVP concentrations and clinical and laboratory abnormalities were monitored. Of the 75 infants randomized (26 to OW, 25 to TW, and 24 to OD dosing), 63 completed the 32-week follow-up visit. No severe skin, hepatic, or renal toxicity related to NVP was observed. Neutropenia occurred in 8 infants. Trough NVP levels were lower than the therapeutic target (100 ng/mL) in 48 of 75 (64.0%) samples from infants in the OW arm, 3 of 65 (4.6%) samples in the TW arm, and 0 of 72 samples in the OD arm. Median (range) trough NVP concentrations were 64 ng/mL (range<25–1519 ng/mL) with OW dosing; 459 (range<25–1386 ng/mL) with TW dosing; and 1348 (range108–4843 ng/ml) with OD dosing. Our data indicate that NVP prophylaxis for 6 months was safe and well tolerated in infants. OD NVP dosing resulted in all infants with trough concentration greater than the therapeutic target and maintenance of high drug concentrations. A phase 3 study is planned to assess the efficacy of OD infant NVP regimen to prevent breast-feeding HIV-1 transmission.</description><identifier>ISSN: 1525-4135</identifier><identifier>EISSN: 1944-7884</identifier><identifier>DOI: 10.1097/00126334-200312150-00006</identifier><identifier>PMID: 14657758</identifier><identifier>CODEN: JDSRET</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins, Inc</publisher><subject>Acquired Immunodeficiency Syndrome - prevention & control ; Acquired Immunodeficiency Syndrome - transmission ; Adolescent ; Adult ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - pharmacokinetics ; Anti-HIV Agents - therapeutic use ; Babies ; Biological and medical sciences ; Breast Feeding ; Breastfeeding & lactation ; Clinical trials ; Disease transmission ; Epidemiologic Research Design ; Female ; Fundamental and applied biological sciences. Psychology ; HIV ; Human immunodeficiency virus ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Infant ; Infant, Newborn ; Infectious diseases ; Maternal Age ; Medical sciences ; Medical treatment ; Metabolic Clearance Rate ; Microbiology ; Miscellaneous ; Nevirapine - administration & dosage ; Nevirapine - pharmacokinetics ; Nevirapine - therapeutic use ; Pregnancy ; Pregnancy Complications, Infectious - prevention & control ; Pregnancy Complications, Infectious - virology ; Safety ; South Africa ; Time Factors ; Viral diseases ; Virology ; Zimbabwe</subject><ispartof>Journal of acquired immune deficiency syndromes (1999), 2003-12, Vol.34 (5), p.482-490</ispartof><rights>2003 Lippincott Williams & Wilkins, Inc.</rights><rights>2004 INIST-CNRS</rights><rights>Copyright Lippincott Williams & Wilkins Dec 15, 2003</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4946-f96f227bc480bb8c2f6b04375170c3e7ddbb3174e9bff1dfb3fa72e26c791e633</citedby><cites>FETCH-LOGICAL-c4946-f96f227bc480bb8c2f6b04375170c3e7ddbb3174e9bff1dfb3fa72e26c791e633</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttp://ovidsp.ovid.com/ovidweb.cgi?T=JS&NEWS=n&CSC=Y&PAGE=fulltext&D=ovft&AN=00126334-200312150-00006$$EHTML$$P50$$Gwolterskluwer$$H</linktohtml><link.rule.ids>314,776,780,4594,27903,27904,65210</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15349329$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14657758$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shetty, Avinash K</creatorcontrib><creatorcontrib>Coovadia, Hoosen M</creatorcontrib><creatorcontrib>Mirochnick, Mark M</creatorcontrib><creatorcontrib>Maldonado, Yvonne</creatorcontrib><creatorcontrib>Mofenson, Lynne M</creatorcontrib><creatorcontrib>Eshleman, Susan H</creatorcontrib><creatorcontrib>Fleming, Thomas</creatorcontrib><creatorcontrib>Emel, Lynda</creatorcontrib><creatorcontrib>George, Kathy</creatorcontrib><creatorcontrib>Katzenstein, David A</creatorcontrib><creatorcontrib>Wells, Jennifer</creatorcontrib><creatorcontrib>Maponga, Charles C</creatorcontrib><creatorcontrib>Mwatha, Anthony</creatorcontrib><creatorcontrib>Jones, Samuel Adeniyi</creatorcontrib><creatorcontrib>Abdool Karim, Salim S</creatorcontrib><creatorcontrib>Bassett, Mary T</creatorcontrib><creatorcontrib>HIVNET 023 Study Team</creatorcontrib><title>Safety and Trough Concentrations of Nevirapine Prophylaxis Given Daily, Twice Weekly, or Weekly in Breast-Feeding Infants From Birth to 6 Months</title><title>Journal of acquired immune deficiency syndromes (1999)</title><addtitle>J Acquir Immune Defic Syndr</addtitle><description>Despite the success of antiretroviral prophylaxis in reducing mother-to-child HIV-1 transmission, postpartum transmission through breast milk remains a problem. Antiretroviral administration to the infant during the period of breast-feeding could protect against postnatal transmission. An open-label phase 1/2 study was designed to assess the safety and trough concentrations of nevirapine (NVP) given once weekly (OW), twice weekly (TW), or once daily (OD) to HIV-exposed breast-feeding infants for 24 weeks. Following maternal dosing with 200 mg NVP orally at onset of labor, breast-feeding infants were randomized within 48 hours of birth to 1 of 3 regimensarm 1, NVP given OW (4 mg/kg from birth to 14 days, ↑ to 8 mg/kg from 15 days to 24 weeks), arm 2, NVP given TW (4 mg/kg from birth to 14 days, ↑ to 8 mg/kg from 15 days to 24 weeks), and arm 3, NVP given OD (2 mg/kg from birth to 14 days, ↑ to 4 mg/kg from 15 days to 24 weeks). Trough NVP concentrations and clinical and laboratory abnormalities were monitored. Of the 75 infants randomized (26 to OW, 25 to TW, and 24 to OD dosing), 63 completed the 32-week follow-up visit. No severe skin, hepatic, or renal toxicity related to NVP was observed. Neutropenia occurred in 8 infants. Trough NVP levels were lower than the therapeutic target (100 ng/mL) in 48 of 75 (64.0%) samples from infants in the OW arm, 3 of 65 (4.6%) samples in the TW arm, and 0 of 72 samples in the OD arm. Median (range) trough NVP concentrations were 64 ng/mL (range<25–1519 ng/mL) with OW dosing; 459 (range<25–1386 ng/mL) with TW dosing; and 1348 (range108–4843 ng/ml) with OD dosing. Our data indicate that NVP prophylaxis for 6 months was safe and well tolerated in infants. OD NVP dosing resulted in all infants with trough concentration greater than the therapeutic target and maintenance of high drug concentrations. A phase 3 study is planned to assess the efficacy of OD infant NVP regimen to prevent breast-feeding HIV-1 transmission.</description><subject>Acquired Immunodeficiency Syndrome - prevention & control</subject><subject>Acquired Immunodeficiency Syndrome - transmission</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Anti-HIV Agents - pharmacokinetics</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Babies</subject><subject>Biological and medical sciences</subject><subject>Breast Feeding</subject><subject>Breastfeeding & lactation</subject><subject>Clinical trials</subject><subject>Disease transmission</subject><subject>Epidemiologic Research Design</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Infectious diseases</subject><subject>Maternal Age</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Metabolic Clearance Rate</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Nevirapine - administration & dosage</subject><subject>Nevirapine - pharmacokinetics</subject><subject>Nevirapine - therapeutic use</subject><subject>Pregnancy</subject><subject>Pregnancy Complications, Infectious - prevention & control</subject><subject>Pregnancy Complications, Infectious - virology</subject><subject>Safety</subject><subject>South Africa</subject><subject>Time Factors</subject><subject>Viral diseases</subject><subject>Virology</subject><subject>Zimbabwe</subject><issn>1525-4135</issn><issn>1944-7884</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kt1u1DAQhSMEomXhFZCFBFcE_Jc4vqQLWyqVH4lFXFqOM27cZu2t7XTZt-CRSbuBSkjMzYyl7xyN5rgoEMFvCJbiLcaE1ozxkmLMCCUVLvFU9YPimEjOS9E0_OE0V7QqOWHVUfEkpctJVXMuHxdHhNeVEFVzXPz6pi3kPdK-Q-sYxoseLYM34HPU2QWfULDoM9y4qLfOA_oaw7bfD_qnS-jU3YBH77Ub9q_ReucMoB8AV7evEOcROY9OIuiUyxVA5_wFOvNW-5zQKoYNOnEx9ygHVKNPwec-PS0eWT0keDb3RfF99WG9_Fiefzk9W747Lw2XvC6trC2lojW8wW3bGGrrFnMmKiKwYSC6rm0ZERxkay3pbMusFhRobYQkMN1uUbw6-G5juB4hZbVxycAwaA9hTIpIKjCfzrsoXvwDXoYx-mk3RRmrGaZ3bs0BMjGkFMGqbXQbHfeKYHUbmfoTmfobmbqLbJI-n_3HdgPdvXDOaAJezoBORg82am9cuucqxiWjcuL4gduFIUNMV8O4g6h60EPu1f--DPsNV3euLA</recordid><startdate>20031215</startdate><enddate>20031215</enddate><creator>Shetty, Avinash K</creator><creator>Coovadia, Hoosen M</creator><creator>Mirochnick, Mark M</creator><creator>Maldonado, Yvonne</creator><creator>Mofenson, Lynne M</creator><creator>Eshleman, Susan H</creator><creator>Fleming, Thomas</creator><creator>Emel, Lynda</creator><creator>George, Kathy</creator><creator>Katzenstein, David A</creator><creator>Wells, Jennifer</creator><creator>Maponga, Charles C</creator><creator>Mwatha, Anthony</creator><creator>Jones, Samuel Adeniyi</creator><creator>Abdool Karim, Salim S</creator><creator>Bassett, Mary T</creator><general>Lippincott Williams & Wilkins, Inc</general><general>Lippincott Williams & Wilkins</general><general>Lippincott Williams & Wilkins Ovid Technologies</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T2</scope><scope>7T5</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>7U2</scope></search><sort><creationdate>20031215</creationdate><title>Safety and Trough Concentrations of Nevirapine Prophylaxis Given Daily, Twice Weekly, or Weekly in Breast-Feeding Infants From Birth to 6 Months</title><author>Shetty, Avinash K ; Coovadia, Hoosen M ; Mirochnick, Mark M ; Maldonado, Yvonne ; Mofenson, Lynne M ; Eshleman, Susan H ; Fleming, Thomas ; Emel, Lynda ; George, Kathy ; Katzenstein, David A ; Wells, Jennifer ; Maponga, Charles C ; Mwatha, Anthony ; Jones, Samuel Adeniyi ; Abdool Karim, Salim S ; Bassett, Mary T</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4946-f96f227bc480bb8c2f6b04375170c3e7ddbb3174e9bff1dfb3fa72e26c791e633</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Acquired Immunodeficiency Syndrome - prevention & control</topic><topic>Acquired Immunodeficiency Syndrome - transmission</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Anti-HIV Agents - pharmacokinetics</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Babies</topic><topic>Biological and medical sciences</topic><topic>Breast Feeding</topic><topic>Breastfeeding & lactation</topic><topic>Clinical trials</topic><topic>Disease transmission</topic><topic>Epidemiologic Research Design</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. 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Antiretroviral administration to the infant during the period of breast-feeding could protect against postnatal transmission. An open-label phase 1/2 study was designed to assess the safety and trough concentrations of nevirapine (NVP) given once weekly (OW), twice weekly (TW), or once daily (OD) to HIV-exposed breast-feeding infants for 24 weeks. Following maternal dosing with 200 mg NVP orally at onset of labor, breast-feeding infants were randomized within 48 hours of birth to 1 of 3 regimensarm 1, NVP given OW (4 mg/kg from birth to 14 days, ↑ to 8 mg/kg from 15 days to 24 weeks), arm 2, NVP given TW (4 mg/kg from birth to 14 days, ↑ to 8 mg/kg from 15 days to 24 weeks), and arm 3, NVP given OD (2 mg/kg from birth to 14 days, ↑ to 4 mg/kg from 15 days to 24 weeks). Trough NVP concentrations and clinical and laboratory abnormalities were monitored. Of the 75 infants randomized (26 to OW, 25 to TW, and 24 to OD dosing), 63 completed the 32-week follow-up visit. No severe skin, hepatic, or renal toxicity related to NVP was observed. Neutropenia occurred in 8 infants. Trough NVP levels were lower than the therapeutic target (100 ng/mL) in 48 of 75 (64.0%) samples from infants in the OW arm, 3 of 65 (4.6%) samples in the TW arm, and 0 of 72 samples in the OD arm. Median (range) trough NVP concentrations were 64 ng/mL (range<25–1519 ng/mL) with OW dosing; 459 (range<25–1386 ng/mL) with TW dosing; and 1348 (range108–4843 ng/ml) with OD dosing. Our data indicate that NVP prophylaxis for 6 months was safe and well tolerated in infants. OD NVP dosing resulted in all infants with trough concentration greater than the therapeutic target and maintenance of high drug concentrations. A phase 3 study is planned to assess the efficacy of OD infant NVP regimen to prevent breast-feeding HIV-1 transmission.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>14657758</pmid><doi>10.1097/00126334-200312150-00006</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| issn | 1525-4135 1944-7884 |
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| source | MEDLINE; Journals@Ovid LWW Legacy Archive; Journals@Ovid Complete; Free E- Journals |
| subjects | Acquired Immunodeficiency Syndrome - prevention & control Acquired Immunodeficiency Syndrome - transmission Adolescent Adult Anti-HIV Agents - administration & dosage Anti-HIV Agents - pharmacokinetics Anti-HIV Agents - therapeutic use Babies Biological and medical sciences Breast Feeding Breastfeeding & lactation Clinical trials Disease transmission Epidemiologic Research Design Female Fundamental and applied biological sciences. Psychology HIV Human immunodeficiency virus Human immunodeficiency virus 1 Human viral diseases Humans Infant Infant, Newborn Infectious diseases Maternal Age Medical sciences Medical treatment Metabolic Clearance Rate Microbiology Miscellaneous Nevirapine - administration & dosage Nevirapine - pharmacokinetics Nevirapine - therapeutic use Pregnancy Pregnancy Complications, Infectious - prevention & control Pregnancy Complications, Infectious - virology Safety South Africa Time Factors Viral diseases Virology Zimbabwe |
| title | Safety and Trough Concentrations of Nevirapine Prophylaxis Given Daily, Twice Weekly, or Weekly in Breast-Feeding Infants From Birth to 6 Months |
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