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Lopinavir/ritonavir monotherapy as a simplification strategy in routine clinical practice.
J Antimicrob Chemother. 2007 Aug; 60(2):436-9.JA

Abstract

OBJECTIVES

The efficacy and safety of lopinavir/ritonavir monotherapy has been explored with promising results in well-controlled, randomized clinical trials. However, less information about its clinical usefulness in routine clinical practice is currently available. The objective of this study was to assess the effectiveness and safety of monotherapy with lopinavir/ritonavir as a treatment simplification strategy in HIV-infected patients with viral suppression outside a clinical trial setting.

METHODS

Fifty-one subjects who were switched to lopinavir/ritonavir monotherapy and whose HIV-1 RNA was <50 copies/mL were included in this retrospective study. Data were obtained from a prospectively compiled database. The primary endpoint was the percentage of subjects who maintained viral suppression after 48 weeks of follow-up. Secondary endpoints included the incidence of adverse events and changes in CD4+ T cell count and in lipid profile.

RESULTS

Two patients lost viral suppression, seven patients interrupted lopinavir/ritonavir monotherapy because of adverse events and four patients were lost before completing 48 weeks of follow-up. Thus, 38/40 (95.0%) patients maintained viral suppression when only subjects whose outcomes were available up to week 48 were considered and 38/51 (74.5%) patients maintained viral suppression when subjects who discontinued therapy or who were lost to follow-up were considered as treatment failures. The mean CD4+ T cell count significantly increased, from 541 (280) cells/mm3 at baseline to 609 (212) cells/mm3 at week 48 of follow-up (P=0.034). This increase was similar to that observed in the 48 weeks prior to lopinavir/ritonavir monotherapy (P=0.792). Although total cholesterol remained unchanged, there was a significant decrease in triglyceride levels during follow-up (P=0.029).

CONCLUSIONS

Monotherapy with lopinavir/ritonavir is safe and effective as a treatment simplification approach in HIV-1-infected patients with sustained viral suppression in routine clinical practice, particularly in those patients already receiving a lopinavir/ritonavir-based antiretroviral regimen.

Authors+Show Affiliations

Lluita contra la SIDA Foundation, Germans Trias i Pujol Hospital, Badalona, and Universidad Autónoma de Barcelona, Spain. jmolto@flsida.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17556354

Citation

Moltó, José, et al. "Lopinavir/ritonavir Monotherapy as a Simplification Strategy in Routine Clinical Practice." The Journal of Antimicrobial Chemotherapy, vol. 60, no. 2, 2007, pp. 436-9.
Moltó J, Santos JR, Negredo E, et al. Lopinavir/ritonavir monotherapy as a simplification strategy in routine clinical practice. J Antimicrob Chemother. 2007;60(2):436-9.
Moltó, J., Santos, J. R., Negredo, E., Miranda, C., Videla, S., & Clotet, B. (2007). Lopinavir/ritonavir monotherapy as a simplification strategy in routine clinical practice. The Journal of Antimicrobial Chemotherapy, 60(2), 436-9.
Moltó J, et al. Lopinavir/ritonavir Monotherapy as a Simplification Strategy in Routine Clinical Practice. J Antimicrob Chemother. 2007;60(2):436-9. PubMed PMID: 17556354.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lopinavir/ritonavir monotherapy as a simplification strategy in routine clinical practice. AU - Moltó,José, AU - Santos,José Ramón, AU - Negredo,Eugenia, AU - Miranda,Cristina, AU - Videla,Sebastià, AU - Clotet,Bonaventura, Y1 - 2007/06/07/ PY - 2007/6/9/pubmed PY - 2007/12/6/medline PY - 2007/6/9/entrez SP - 436 EP - 9 JF - The Journal of antimicrobial chemotherapy JO - J Antimicrob Chemother VL - 60 IS - 2 N2 - OBJECTIVES: The efficacy and safety of lopinavir/ritonavir monotherapy has been explored with promising results in well-controlled, randomized clinical trials. However, less information about its clinical usefulness in routine clinical practice is currently available. The objective of this study was to assess the effectiveness and safety of monotherapy with lopinavir/ritonavir as a treatment simplification strategy in HIV-infected patients with viral suppression outside a clinical trial setting. METHODS: Fifty-one subjects who were switched to lopinavir/ritonavir monotherapy and whose HIV-1 RNA was <50 copies/mL were included in this retrospective study. Data were obtained from a prospectively compiled database. The primary endpoint was the percentage of subjects who maintained viral suppression after 48 weeks of follow-up. Secondary endpoints included the incidence of adverse events and changes in CD4+ T cell count and in lipid profile. RESULTS: Two patients lost viral suppression, seven patients interrupted lopinavir/ritonavir monotherapy because of adverse events and four patients were lost before completing 48 weeks of follow-up. Thus, 38/40 (95.0%) patients maintained viral suppression when only subjects whose outcomes were available up to week 48 were considered and 38/51 (74.5%) patients maintained viral suppression when subjects who discontinued therapy or who were lost to follow-up were considered as treatment failures. The mean CD4+ T cell count significantly increased, from 541 (280) cells/mm3 at baseline to 609 (212) cells/mm3 at week 48 of follow-up (P=0.034). This increase was similar to that observed in the 48 weeks prior to lopinavir/ritonavir monotherapy (P=0.792). Although total cholesterol remained unchanged, there was a significant decrease in triglyceride levels during follow-up (P=0.029). CONCLUSIONS: Monotherapy with lopinavir/ritonavir is safe and effective as a treatment simplification approach in HIV-1-infected patients with sustained viral suppression in routine clinical practice, particularly in those patients already receiving a lopinavir/ritonavir-based antiretroviral regimen. SN - 0305-7453 UR - https://www.unboundmedicine.com/medline/citation/17556354/Lopinavir/ritonavir_monotherapy_as_a_simplification_strategy_in_routine_clinical_practice_ L2 - https://academic.oup.com/jac/article-lookup/doi/10.1093/jac/dkm198 DB - PRIME DP - Unbound Medicine ER -