Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women
Background Late-presenting pregnant women pose a challenge in the prevention of HIV-1 mother-to-child-transmission. We compared the safety and efficacy of raltegravir and lopinavir/ritonavir for this population. Methods We did a single-center, pilot, open-label, randomized trial in Brazil (N = 44). We randomly allocated late-presenting HIV-infected pregnant women (older than 18 years with a plasma HIV-1 RNA >1000 copies/mL) to receive raltegravir 400 mg twice a day or lopinavir/ritonavir 400/100 mg twice a day plus zidovudine and lamivudine (1:1). The primary endpoint was virological suppression at delivery (HIV-1 RNA <50 copies per mL), in all patients who received at least one dose of study drugs (modified intention-to-treat analysis). Missing information was treated as failure. We assessed safety in all patients. Results We enrolled and randomly assigned treatment to 33 patients (17 in raltegravir group) between June 2015 and June 2017. The study was interrupted by the IRB because a significant difference between arms was detected in an interim analysis. All patients completed follow up at delivery. At delivery, virological suppression was achieved by 13/17 (76.5%) of patients in raltegravir group, versus 4/16 (25.0%) in lopinavir/ritonavir group (RR 3.1, 95% CI: 1.3-7.4). Patients in raltegravir group had significantly higher proportion of virological suppression at 2, 4, and 6 weeks than lopinavir/ritonavir group. Adverse events were most of mild intensity, but patients in lopinavir/ritonavir group had significantly more gastrointestinal adverse events. There was neither discontinuation nor deaths in this trial. Conclusion Raltegravir might be a first-line option for treatment of HIV-infected late-presenting pregnant women.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
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| Enthalten in: |
HIV clinical trials - 19(2018), 3 vom: 01. Juni, Seite 94-100 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Brites, Carlos [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 25.03.2019 Date Revised 25.03.2019 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/15284336.2018.1459343 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM282788743 |
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| LEADER | 01000naa a22002652 4500 | ||
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| 041 | |a eng | ||
| 100 | 1 | |a Brites, Carlos |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women |
| 264 | 1 | |c 2018 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 25.03.2019 | ||
| 500 | |a Date Revised 25.03.2019 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Background Late-presenting pregnant women pose a challenge in the prevention of HIV-1 mother-to-child-transmission. We compared the safety and efficacy of raltegravir and lopinavir/ritonavir for this population. Methods We did a single-center, pilot, open-label, randomized trial in Brazil (N = 44). We randomly allocated late-presenting HIV-infected pregnant women (older than 18 years with a plasma HIV-1 RNA >1000 copies/mL) to receive raltegravir 400 mg twice a day or lopinavir/ritonavir 400/100 mg twice a day plus zidovudine and lamivudine (1:1). The primary endpoint was virological suppression at delivery (HIV-1 RNA <50 copies per mL), in all patients who received at least one dose of study drugs (modified intention-to-treat analysis). Missing information was treated as failure. We assessed safety in all patients. Results We enrolled and randomly assigned treatment to 33 patients (17 in raltegravir group) between June 2015 and June 2017. The study was interrupted by the IRB because a significant difference between arms was detected in an interim analysis. All patients completed follow up at delivery. At delivery, virological suppression was achieved by 13/17 (76.5%) of patients in raltegravir group, versus 4/16 (25.0%) in lopinavir/ritonavir group (RR 3.1, 95% CI: 1.3-7.4). Patients in raltegravir group had significantly higher proportion of virological suppression at 2, 4, and 6 weeks than lopinavir/ritonavir group. Adverse events were most of mild intensity, but patients in lopinavir/ritonavir group had significantly more gastrointestinal adverse events. There was neither discontinuation nor deaths in this trial. Conclusion Raltegravir might be a first-line option for treatment of HIV-infected late-presenting pregnant women | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a HIV-1 | |
| 650 | 4 | |a Lopinavir/ritonavir | |
| 650 | 4 | |a Mother-to-child-transmission | |
| 650 | 4 | |a Pregnant women | |
| 650 | 4 | |a Raltegravir | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a RNA, Viral |2 NLM | |
| 650 | 7 | |a lopinavir-ritonavir drug combination |2 NLM | |
| 650 | 7 | |a Lopinavir |2 NLM | |
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| 650 | 7 | |a Raltegravir Potassium |2 NLM | |
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| 650 | 7 | |a Ritonavir |2 NLM | |
| 650 | 7 | |a O3J8G9O825 |2 NLM | |
| 700 | 1 | |a Nóbrega, Isabella |e verfasserin |4 aut | |
| 700 | 1 | |a Luz, Estela |e verfasserin |4 aut | |
| 700 | 1 | |a Travassos, Ana Gabriela |e verfasserin |4 aut | |
| 700 | 1 | |a Lorenzo, Cynthia |e verfasserin |4 aut | |
| 700 | 1 | |a Netto, Eduardo M |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t HIV clinical trials |d 2000 |g 19(2018), 3 vom: 01. Juni, Seite 94-100 |w (DE-627)NLM114850178 |x 1528-4336 |7 nnns |
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