Document Detail


Efficacy of low-dose boosted saquinavir once daily plus nucleoside reverse transcriptase inhibitors in pregnant HIV-1-infected women with a therapeutic drug monitoring strategy.
MedLine Citation:
PMID:  17417070     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The efficacy of low-dose, ritonavir-boosted saquinavir (SQV/rtv) once daily plus 2 nucleoside retrotranscriptase inhibitors (NRTIs) in pregnant human immunodeficiency virus (HIV)-1-infected women was prospectively evaluated, ensuring a SQV minimum concentration (Cmin) >/=100 ng/mL with a therapeutic drug monitoring strategy. The primary clinical endpoint was the percentage of women with an HIV-RNA viral load (VL) of <50 copies/mL at the time of delivery. Forty-nine pregnancy episodes were included, with a median CD4 count and VL of 441/muL and 3710 copies/mL, respectively. Two patients were lost to follow-up and 1 patient discontinued treatment because of abdominal discomfort. SQV levels were in excess of the target Cmin in 43 of 46 episodes (93.4%) in which the end of pregnancy was reached on 1200/100 mg daily. The dosage was increased to 1600/100 mg in the remaining 3 episodes to achieve the target levels. By an intention-to-treat analysis, VL was undetectable at delivery in 43 episodes (87.7%; 95% confidence interval, 78.5-96.9) after a median of 18 weeks of treatment (range, 3-39). In the 3 episodes remaining, VLs of 110,400 copies/mL and no available data were observed after only 3 weeks of treatment. Mild adverse events attributable to SQV/rtv occurred in 6 of 49 pregnancies (12.2%). No cases of HIV vertical transmission were observed. The pharmacokinetics, efficacy, and tolerability of this regimen suggest that once-daily low-dose boosted SQV may be considered an appropriate option in PI-naive or limited-PI-experienced HIV-infected pregnant women. Nevertheless, therapeutic drug monitoring is advisable to maintain appropriate levels throughout pregnancy.
Authors:
Luis F Lopez-Cortes; Rosa Ruiz-Valderas; Antonio Rivero; Angela Camacho; Manuel Marquez-Solero; Jesus Santos; Milagros García-Lazaro; Pompeyo Viciana; Jesus Rodriguez-Baños; Antonio Ocampo
Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  Therapeutic drug monitoring     Volume:  29     ISSN:  0163-4356     ISO Abbreviation:  Ther Drug Monit     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-04-09     Completed Date:  2007-06-21     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  7909660     Medline TA:  Ther Drug Monit     Country:  United States    
Other Details:
Languages:  eng     Pagination:  171-6     Citation Subset:  IM    
Affiliation:
Infectious Diseases Service, Hospitales Universitarios Virgen del Rocío, Seville, Spain. lflopez@telefonica.net
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MeSH Terms
Descriptor/Qualifier:
Adult
Drug Monitoring
Drug Therapy, Combination
Female
HIV Infections / drug therapy*,  prevention & control,  transmission
HIV Protease Inhibitors / adverse effects*,  blood,  therapeutic use
Humans
Infectious Disease Transmission, Vertical / prevention & control
Pregnancy
Pregnancy Complications, Infectious / drug therapy*
Prospective Studies
Reverse Transcriptase Inhibitors / therapeutic use*
Ritonavir / therapeutic use
Saquinavir / adverse effects*,  blood,  therapeutic use
Viral Load
Chemical
Reg. No./Substance:
0/HIV Protease Inhibitors; 0/Reverse Transcriptase Inhibitors; 0/Ritonavir; 127779-20-8/Saquinavir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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