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Efficacy and safety of lopinavir/ritonavir (LPV/r) in antiretroviral-experienced subjects infected with different subtypes of HIV-1

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Journal of the International AIDS Society201013 (Suppl 4) :P30

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  • Reverse Transcriptase
  • Sequence Data
  • Resistance Mutation
  • Similar Efficacy
  • Transcriptase Inhibitor


There are three classes of HIV-1 based on diversity of the viral envelope: M (major), O (outlying) and N (new). The M group is subclassified into nine major subtypes including A—D, F—H, J and K, as well as several recombinant forms. There is a growing need to evaluate antiretroviral (ARV) treatment in these diverse subtypes.


M06-802 was an open-label, global, 48-week phase III trial. 599 ARV-experienced, HIV-1-infected subjects were randomized 1:1 to receive LPV/r 800/200mg QD or 400/100mg BID with ≥2 investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors. Classification of HIV-1 viruses by subtype was determined by analyzing sequences of the env gene for this post hoc analysis.


Of the 595 subjects with available sequence data, 386 (65%) were infected with subtype B, 121 (20%) were infected with subtype C, 88 (15%) were infected with another subtype. Subjects infected with subtype B were more likely to be male (75%), white (56%), and living in North America (N.A.) (52%), while subjects infected with subtype C were more likely to be female (56%), black (83%), and living outside of N.A. or Western Europe (W.E.) (99%). Subjects infected with other subtypes were more likely to be male (56%), white (88%) and living outside of N.A. or W.E. (82%). The proportion of subjects with subtype B responding to treatment at week 48 as analyzed using the FDA-TLOVR method (53%) was similar to that of subtype C subjects (57%, P=0.465) and non-B subtype subjects (55%, P=0.731) (Figure 1). The prevalence of moderate/severe treatment-related adverse events was similar across subtypes. There was a nonsignificant trend to more frequent emergence of new protease resistance mutations in subtype B (18%) vs. subtype C (8%, P=0.277) or non-B (7%, P=0.088) subjects; however, subtype B subjects were more likely to have previously been treated with PIs.
Figure 1
Figure 1

Percent of subjects infected with different subtypes that have plasma HIV-1 RNA <50 copies/mL, FDA-TLOVR analysis


LPV/r demonstrated similar efficacy and safety among subjects infected with different HIV-1 subtypes.

Authors’ Affiliations

Abbott, Abbott Park, USA


© Maroldo et al; licensee BioMed Central Ltd. 2010

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.