A randomized controlled trial to assess safety, tolerability, and antepartum viral load with increased lopinavir/ritonavir dosage in pregnancy
HIV mother-to-child transmission (MTCT) is significantly reduced if antepartum viral load (apVL) is<50 copies/mL. Pharmacokinetic studies suggest increasing the dosage of lopinavir/ritonavir (LPV/r) in pregnancy. It is important to assess tolerance, safety, and rate of patients presenting a apVL<50 copies/mL when treating with increased dose of LPV/r during pregnancy. Confirmed HIV-infected pregnant women with a fetus at a gestational age of 14-33 weeks were randomly assigned to receive LPV/r 400/100 or 600/150 mg b.i.d. plus two nucleoside analogues (NRTIs). Treatment was discontinued in the case of alanine transaminase (ALT) of grade III elevation or higher, glucose, or triglycerides. Thirty-two women were randomized to the LPV/r 400/100 mg dose, and 31 women were randomized to the 600/150 mg dose. Overall, 9.4% of the women receiving the conventional dose, and 17.2% receiving the increased dose, discontinued treatment because of adverse events (p=0.29). The rates of gastrointestinal (GI) symptoms, laboratory abnormalities, preterm delivery, and low birth weight were similar in both groups. There were no cases of HIV MTCT. Among the women with a baseline VL>50 copies/mL assigned to the conventional dose group, 45% (95% confidence interval [CI] 62.5-27.5%) had a apVL>50 copies/mL compared with 10.5% (95% CI 21.6-0.6%) of those assigned to the increased dose group (p=0.01). There was no significant difference found for the patients with a baseline VL<50 copies/mL. In pregnant women with a baseline VL>50 copies/mL, it may be warranted to initiate LPV/r dosing at 600/150 mg, whereas the conventional dose is sufficient for pregnant women with a baseline VL<50 copies/mL.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2013 |
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| Erschienen: |
2013 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
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| Enthalten in: |
AIDS patient care and STDs - 27(2013), 11 vom: 17. Nov., Seite 589-95 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bonafe, Simone Martins [VerfasserIn] |
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| Links: |
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| Themen: |
2494G1JF75 |
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| Anmerkungen: |
Date Completed 04.02.2014 Date Revised 13.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1089/apc.2013.0159 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM231819560 |
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| 100 | 1 | |a Bonafe, Simone Martins |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A randomized controlled trial to assess safety, tolerability, and antepartum viral load with increased lopinavir/ritonavir dosage in pregnancy |
| 264 | 1 | |c 2013 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
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| 500 | |a Date Revised 13.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a HIV mother-to-child transmission (MTCT) is significantly reduced if antepartum viral load (apVL) is<50 copies/mL. Pharmacokinetic studies suggest increasing the dosage of lopinavir/ritonavir (LPV/r) in pregnancy. It is important to assess tolerance, safety, and rate of patients presenting a apVL<50 copies/mL when treating with increased dose of LPV/r during pregnancy. Confirmed HIV-infected pregnant women with a fetus at a gestational age of 14-33 weeks were randomly assigned to receive LPV/r 400/100 or 600/150 mg b.i.d. plus two nucleoside analogues (NRTIs). Treatment was discontinued in the case of alanine transaminase (ALT) of grade III elevation or higher, glucose, or triglycerides. Thirty-two women were randomized to the LPV/r 400/100 mg dose, and 31 women were randomized to the 600/150 mg dose. Overall, 9.4% of the women receiving the conventional dose, and 17.2% receiving the increased dose, discontinued treatment because of adverse events (p=0.29). The rates of gastrointestinal (GI) symptoms, laboratory abnormalities, preterm delivery, and low birth weight were similar in both groups. There were no cases of HIV MTCT. Among the women with a baseline VL>50 copies/mL assigned to the conventional dose group, 45% (95% confidence interval [CI] 62.5-27.5%) had a apVL>50 copies/mL compared with 10.5% (95% CI 21.6-0.6%) of those assigned to the increased dose group (p=0.01). There was no significant difference found for the patients with a baseline VL<50 copies/mL. In pregnant women with a baseline VL>50 copies/mL, it may be warranted to initiate LPV/r dosing at 600/150 mg, whereas the conventional dose is sufficient for pregnant women with a baseline VL<50 copies/mL | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a Protease Inhibitors |2 NLM | |
| 650 | 7 | |a RNA, Viral |2 NLM | |
| 650 | 7 | |a Lopinavir |2 NLM | |
| 650 | 7 | |a 2494G1JF75 |2 NLM | |
| 650 | 7 | |a Ritonavir |2 NLM | |
| 650 | 7 | |a O3J8G9O825 |2 NLM | |
| 700 | 1 | |a Costa, Durval A Gomes |e verfasserin |4 aut | |
| 700 | 1 | |a Vaz, Maria J Rodrigues |e verfasserin |4 aut | |
| 700 | 1 | |a Senise, Jorge Figueiredo |e verfasserin |4 aut | |
| 700 | 1 | |a Pott-Junior, Henrique |e verfasserin |4 aut | |
| 700 | 1 | |a Machado, Rachel H Vieira |e verfasserin |4 aut | |
| 700 | 1 | |a Castelo, Adauto |e verfasserin |4 aut | |
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| 773 | 1 | 8 | |g volume:27 |g year:2013 |g number:11 |g day:17 |g month:11 |g pages:589-95 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1089/apc.2013.0159 |3 Volltext |
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