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

Therapeutic Drug Monitoring

Volumn 29, Issue 2, 2007, Pages 171-176

  Lopez Cortes, Luis F ^a   Ruiz Valderas, Rosa ^a   Rivero, Antonio ^b   Camacho, Angela ^b   Marquez Solero, Manuel ^c   Santos, Jesus ^c   García Lazaro, Milagros ^b   Viciana, Pompeyo ^a   Rodriguez Baños, Jesus ^d   Ocampo, Antonio ^e,f  

^a HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^b HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^c HOSPITAL UNIVERSITARIO VIRGEN DE LA VICTORIA   (Spain)

^d HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

^e HOSPITAL XERAL CÍES   (Spain)

^f Grupo Andaluz para El Estudio de Las Enfermedades Infecciosas (GAEI)

Author keywords

Antiretroviral treatment; Pharmacokinetics; Pregnancy; Saquinavir; Therapeutic drug monitoring

Indexed keywords

ABACAVIR; DIDANOSINE; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; RNA; SAQUINAVIR; STAVUDINE; TENOFOVIR; ZIDOVUDINE;

ABDOMINAL DISCOMFORT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CD4 LYMPHOCYTE COUNT; CESAREAN SECTION; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG MONITORING; DRUG SUBSTITUTION; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HAZARD RATIO; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LOW DRUG DOSE; NAUSEA; PREGNANT WOMAN; PRIORITY JOURNAL; SIDE EFFECT; VAGINAL DELIVERY; VERTICAL TRANSMISSION; VIRUS LOAD;

ADULT; DISEASE TRANSMISSION, VERTICAL; DRUG MONITORING; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PROSPECTIVE STUDIES; REVERSE TRANSCRIPTASE INHIBITORS; RITONAVIR; SAQUINAVIR; VIRAL LOAD;

EID: 34248148055     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/FTD.0b013e31803bb54e     Document Type: Article

References (33)

1. Mofenson LM, Lambert JS, Stiehm ER, et al. Risk factors for perinatal transmission of human immunodeficiency virus type 1 in women treated with zidovudine. N Engl J Med. 1999;341:385-393.
2. The European Collaborative Study. Maternal viral load and vertical transmission of HIV-1: an important factor but not the only one. AIDS. 1999;13:1377-1385.
3. Cooper ER, Charurat M, Mofenson L, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1 infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. 2002;29:484-494.
4. Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States. 6 July 2006. Available at http://www.hivatis.org.
5. Figgitt DP, Plosker GL. Saquinavir soft-gel capsule: an updated review of its use in the management of HIV infection. Drugs. 2000;60:481-516.
6. Vithayasai V, Moyle GJ, Supajatura V, et al. Safety and efficacy of saquinavir soft-gelatin capsules + zidovudine + optional lamivudine in pregnancy and prevention of vertical HIV transmission. J Acquir Immune Defic. 2002;30:410-412.
7. Acosta EP, Zorrilla C, Van Dyke R, et al. Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women. HIV Clin Trials. 2001;2:460-465.
8. Merry C, Barry MG, Mulcahy F, et al. Saquinavir pharmacokinetics alone and in combination with ritonavir in HIV-infected patients. AIDS 1997;11:F29-F33.
9. Plosker GL, Scott LJ. Saquinavir: a review of its use in boosted regimens for treating HIV infection. Drugs. 2003;63:1299-1324.
10. Kurowski M, Müller M, Donath F, et al. Single daily doses of saquinavir achieve HIV-inhibitory concentrations when combined with "baby-dose" ritonavir. Eur J Med Res. 1999;4:101-104.
11. Kilby JM, Sfakianos G, Gizzi N, et al. Safety and pharmacokinetics of once-daily regimens of soft-gel capsule saquinavir plus minidose ritonavir in human immunodeficiency virus-negative adults. Antimicrob Agents Chemother. 2000;44:2672-2678.
12. Van HeeswijK RPG, Veldkamp AI, Mulder JW, et al. Once-daily dosing of saquinavir and low-dose ritonavir in HIV-1-infected individuals: a pharmacokinetic pilot study. AIDS. 2000;14:F103-F110.
13. Cardiello PG, van Heeswijk RP, Hassink EA, et al. Simplifying protease inhibitor therapy with once-daily dosing of saquinavir soft-gelatin capsules/ritonavir (1600/100 mg): HIVNAT 001.3 study. J Acquir Immune Defic. 2002;29:464-470.
14. Lopez-Cortes LF, Ruiz-Valderas R, Viciana P, et al. Once-daily saquinavir-sgc plus low-dose Ritonavir (1200/100 mg) in combination with efavirenz: pharmacokinetics and efficacy in HIV-infected patients with prior antiretroviral therapy. J Acquir Immune Defic Syndr. 2003;32:240-242.
15. Lamotte C, Landman R, Peytavin G, et al. Once-daily dosing of saquinavir soft-gel capsules and ritonavir combination in HIV-1-infected patients (IMEA015 study). Antivir Ther. 2004;9:247-256.
16. Ananworanich J, Hill A, Siangphoe U, et al. A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients. Antivir Ther. 2005;10:761-767.
17. Cardiello P, Srasuebkul P, Hassink E, et al. The 48 week efficacy of once-daily saquinavir/ritonavir in patients with undetectable viral load after 3 years of antiretroviral therapy. HIV Med. 2005;6:122-128.
18. Ananworanich J, Siangphoe U, Hill A, et al. Highly active antiretroviral therapy (HAART) retreatment in patients on CD4-guided therapy achieved similar virologic suppression compared with patients on continuous HAART: the HIV Netherlands Australia Thailand Research Collaboration 001.4 Study. J Acquir Immune Defic Syndr. 2005;39:523-529.
19. Lopez-Cortes LF, Marín-Niebla A, Ruiz-Valderas R, et al. Efficacy and pharmacokinetics (plasmatic and intracellular) of low dose saquinavir/ritonavir (1200/100 mg) QD in HIV-patients. Abstract PE4.1/5. 10th European AIDS Conference/EACS. Dublin, 17-20 November 2005.
20. Montaner JS, Schutz M, Schwartz R, et al. Efficacy, safety and pharmacokinetics of once-daily saquinavir soft-gelatin capsule/ritonavir in antiretroviral-naive, HIV-infected patients. Med Gen Med. 2006;8:36.
21. Hawkins DA, Khan W, Moyle JG, et al. Pharmacokinetics, safety, tolerability and efficacy of saquinavir hard-gel capsules/ritonavir plus 2 nucleosides in HIV-1-infected pregnant women. Abstract no. ThPeB7064. XV International AIDS Conference. Bangkok, 11-16 July 2004.
22. Acosta EP, Bardeguez A, Zorrilla CD, et al. Pharmacokinetics of saquinavir plus low-dose ritonavir in human immunodeficiency virus-infected pregnant women. Antimicrob Agents Chemother. 2004;48:430-436.
23. Acosta EP, Kakuda TN, Brundage RC, et al. Pharmacodynamics of HIV-1 protease inhibitors. Clin Infect Dis. 2000:30(Suppl 2):S151-S159.
24. Therapeutic drug monitoring in HIV infection: current status and future directions. Flexner CW, Piscitelli SC, ed. AIDS. 2002;16(Suppl 1):1-38.
25. Mirochnick M, Capparelli E. Pharmacokinetics of antiretrovirals in pregnant women. Clin Pharmacokinet. 2004;43:1071-1087.
26. Back D, Blascke T, Boucher C, et al. A practical guide to performing therapeutic drug monitoring for antiretroviral agents. April 2003. Available at http://www.hivpharmacology.com/.
27. López-Cortés LF, Marín Niebla A, Ruiz-Valderas R, et al. Once-daily saquinavir-hgc plus low dose ritonavir (1200/100 mg) in HIV-infected pregnant women: pharmacokinetics and efficacy. HIV Clin Trials. 2003;4:227-229.
28. Hirsch MS, Brun-Vézinet F, D'Aquila RT, et al. Antiretroviral drug resistance testing in adult HIV-1 infection: recommendations of an International AIDS Society-USA Panel. JAMA 2000;283:2417-2426.
29. Lalezari J. Selecting the optimum dose for a new soft gelatin capsule formulation of saquinavir. NV15107 Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1998;19:195-197.
30. Gieschke R, Fotteler B, Buss N, et al. Relationships between exposure to saquinavir monotherapy and antiviral response in HIV-positive patients. Clin Pharmacokinet. 1999;37:75-86.
31. AIDS Clinical Trials Group. Table of Grading Severity of Adult Adverse Experiences. Rockville, MD: Division of AIDS, National Institute of Allergy and Infectious Diseases; 1996.
32. Marcelin AG, Dalban C, Peytavin G, et al. Clinically relevant interpretation of genotype and relationship to plasma drug concentrations for resistance to saquinavir-ritonavir in human immunodeficiency virus type 1 protease inhibitor-experienced patients. Antimicrob Agents Chemother. 2004;48:4687-4692.
33. Valer L, De Mendoza C, De Requena DG, et al. Impact of HIV genotyping and drug levels on the response to salvage therapy with saquinavir/ritonavir. AIDS. 2002;16:1964-1966.