title: 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.
abstract: 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.affiliation: Infectious Diseases Service, Hospitales Universitarios Virgen del Rocío, Seville, Spain. lflopez@telefonica.net
authors.forename: Luis F
authors.initials: LF
authors.lastname: Lopez-Cortes
authors.forename: Rosa
authors.initials: R
authors.lastname: Ruiz-Valderas
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero
authors.forename: Angela
authors.initials: A
authors.lastname: Camacho
authors.forename: Manuel
authors.initials: M
authors.lastname: Marquez-Solero
authors.forename: Jesus
authors.initials: J
authors.lastname: Santos
authors.forename: Milagros
authors.initials: M
authors.lastname: García-Lazaro
authors.forename: Pompeyo
authors.initials: P
authors.lastname: Viciana
authors.forename: Jesus
authors.initials: J
authors.lastname: Rodriguez-Baños
authors.forename: Antonio
authors.initials: A
authors.lastname: Ocampo
mesh_terms: D000328:Adult; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control / Q000635:transmission; D017320:HIV Protease Inhibitors / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D019438:Ritonavir / Q000627:therapeutic use; D019258:Saquinavir / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D019258:Saquinavir; D019438:Ritonavir