Literature DB >> 16956902

The LOPSAQ study: 48 week analysis of a boosted double protease inhibitor regimen containing lopinavir/ritonavir plus saquinavir without additional antiretroviral therapy.

Schlomo Staszewski1, Errol Babacan, Christoph Stephan, Annette Haberl, Amina Carlebach, Peter Gute, Stephan Klauke, Yvonne Hermschulte, Martin Stuermer, Brenda Dauer.   

Abstract

OBJECTIVES: To evaluate the virological, immunological and clinical responses to the boosted double protease inhibitor (PI) regimen combination of lopinavir/ritonavir and saquinavir ('LOPSAQ') without reverse transcriptase inhibitors (RTI) in HIV-positive patients who have few viable RTI treatment options.
METHODS: Cohort study of 128 heavily pre-treated patients who were experiencing therapy failure on their current regimen due to RTI resistance and/or systemic toxicities. Patients with PI-resistance mutations or RTI toxicity underwent a structured treatment interruption (STI) (n=76) until virus reverted to wild-type or until resolution of toxicity symptoms. Baseline was defined as the time point when lopinavir/ritonavir plus saquinavir therapy was initiated. Virological response was defined as viral load<400 copies/mL at week 48.
RESULTS: A total of 78 (61%) patients experienced a virological response to therapy (ITT). Median viral load at baseline was 5.06 log10 copies/mL; at week 48 median was 2.16 log10 copies. Median CD4 at week 48 was 280 cells/mm3 compared with 172 cells at baseline. At week 48, 78/128 patients were still on therapy. In univariable analyses, significant predictors of virological response included higher CD4 count (P<0.001), lower viral load (P=0.002), less PI-experience (P=0.006) at baseline and fewer PI-resistance mutations (P=0.043) at end of prior failing regimen; in the multivariable analysis only higher CD4 count at baseline (P=0.009) and fewer number of drugs previously taken (P=0.003) could be specified as independent predictors for response.
CONCLUSIONS: The combination of lopinavir/ritonavir and saquinavir without RTIs is a potential option as salvage therapy for patients experiencing therapy failure due to RTI resistance or toxicity. This regimen may not be suitable for patients with very low baseline CD4 cell counts, very broad antiretroviral therapy experience or extensive PI-resistance mutations.

Entities:  

Mesh:

Substances:

Year:  2006        PMID: 16956902     DOI: 10.1093/jac/dkl375

Source DB:  PubMed          Journal:  J Antimicrob Chemother        ISSN: 0305-7453            Impact factor:   5.790


  10 in total

1.  Gag mutations can impact virological response to dual-boosted protease inhibitor combinations in antiretroviral-naïve HIV-infected patients.

Authors:  Lucile Larrouy; C Chazallon; R Landman; C Capitant; G Peytavin; G Collin; C Charpentier; A Storto; G Pialoux; C Katlama; P M Girard; P Yeni; J P Aboulker; F Brun-Vezinet; D Descamps
Journal:  Antimicrob Agents Chemother       Date:  2010-05-03       Impact factor: 5.191

Review 2.  Double-boosted protease inhibitor antiretroviral regimens: what role?

Authors:  Esteban Ribera; Adrian Curran
Journal:  Drugs       Date:  2008       Impact factor: 9.546

3.  HIV-1 replication in central nervous system increases over time on only protease inhibitor therapy.

Authors:  Maximilian Donath; Timo Wolf; Martin Stürmer; Eva Herrmann; Markus Bickel; Pavel Khaykin; Siri Göpel; Peter Gute; Annette Haberl; Philipp de Leuw; Gundolf Schüttfort; Annemarie Berger; Christoph Stephan
Journal:  Med Microbiol Immunol       Date:  2016-07-28       Impact factor: 3.402

4.  Pharmacokinetics of saquinavir, atazanavir, and ritonavir in a twice-daily boosted double-protease inhibitor regimen.

Authors:  Nils von Hentig; Axel Müller; Carsten Rottmann; Timo Wolf; Thomas Lutz; Stephan Klauke; Michael Kurowski; Bruno Oertel; Brenda Dauer; Sebastian Harder; Schlomo Staszewski
Journal:  Antimicrob Agents Chemother       Date:  2007-02-12       Impact factor: 5.191

5.  Pharmacokinetics of an indinavir-ritonavir-fosamprenavir regimen in patients with human immunodeficiency virus.

Authors:  Ighovwerha Ofotokun; Edward P Acosta; Jeffrey L Lennox; Yi Pan; Kirk A Easley
Journal:  Pharmacotherapy       Date:  2008-01       Impact factor: 4.705

6.  Pharmacokinetics of high-dose lopinavir-ritonavir with and without saquinavir or nonnucleoside reverse transcriptase inhibitors in human immunodeficiency virus-infected pediatric and adolescent patients previously treated with protease inhibitors.

Authors:  Brian L Robbins; Edmund V Capparelli; Ellen G Chadwick; Ram Yogev; Leslie Serchuck; Carol Worrell; Mary Elizabeth Smith; Carmelita Alvero; Terence Fenton; Barbara Heckman; Stephen I Pelton; Grace Aldrovandi; William Borkowsky; John Rodman; Peter L Havens
Journal:  Antimicrob Agents Chemother       Date:  2008-07-14       Impact factor: 5.191

7.  Impact of HIV-1 replication on immunological evolution during long-term dual-boosted protease inhibitor therapy.

Authors:  Christoph Stephan; Valentin Bartha; Eva Herrmann; Nils von Hentig; Pavel Khaykin; Gaby Knecht; Peter Gute; Hans-Reinhard Brodt; Martin Stürmer; Annemarie Berger; Markus Bickel
Journal:  Med Microbiol Immunol       Date:  2012-09-15       Impact factor: 3.402

8.  Decrease of atazanavir and lopinavir plasma concentrations in a boosted double human immunodeficiency virus protease inhibitor salvage regimen.

Authors:  Nils von Hentig; Pavel Kaykhin; Christoph Stephan; Errol Babacan; Martin Stürmer; Schlomo Staszewski; Jörn Lötsch
Journal:  Antimicrob Agents Chemother       Date:  2008-04-14       Impact factor: 5.191

9.  Two cases of multidrug-resistant human immunodeficiency virus infection treated with atazanavir and lopinavir/ritonavir combination therapy.

Authors:  Heekyoung Choi; Su Jin Jeong; Han Sung Lee; Bum Sik Chin; Suk Hoon Choi; Sang Hoon Han; Myung Soo Kim; Chang Oh Kim; Jun Yong Choi; Young Goo Song; June Myung Kim
Journal:  J Korean Med Sci       Date:  2008-08       Impact factor: 2.153

10.  Efficacy and safety of a dual boosted protease inhibitor-based regimen, atazanavir and fosamprenavir/ritonavir, against HIV: experience in a pediatric population.

Authors:  Stefano Rusconi; Vania Giacomet; Chiara Mameli; Alessandra Viganò; Ottavia Viganò; Fulvio Adorni; Massimo Galli; Gian Vincenzo Zuccotti
Journal:  BMC Infect Dis       Date:  2012-08-06       Impact factor: 3.090

  10 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.