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A randomised, controlled, Open-label study of revision of antiretroviral regimens containing stavudine (d4T) and/or a Protease Inhibitor (PI) to Zidovudine (ZDV)/Lamivudine (3TC)/Abacavir (ABC) to prevent or reverse lipoatrophy: 48-week data
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A randomised, controlled, Open-label study of revision of antiretroviral regimens containing stavudine (d4T) and/or a Protease Inhibitor (PI) to Zidovudine (ZDV)/Lamivudine (3TC)/Abacavir (ABC) to prevent or reverse lipoatrophy: 48-week data

M. John, I. James, E. McKinnon, D. Nolan, S. Herrmann, A. Cain, O.P. Martinez, A. White and S. Mallal
9th Conference on Retroviruses and Opportunistic Infections (Seattle, U.S.A, 24/02/2002–28/02/2002)
2002
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Abstract

Background: Treatment with Pis (vs no PIs) and d4T (vs other NRTIs) have been independently associated with higher risk of fat wasting (lipoatrophy) in HIV-infected patients. We sought to determine whether the revision of d4T and/or PI-containing regimens to ZDV/3TC/ABC would be safe, efficacious and result in prevention (fat sparing) and/or reversibility (fat restoration) of lipoatrophy. Methods: 40 subjects with stable HIV RNA<400 copies/mL and taking 1 of 3 baseline regimens, d4T/3TC/indinavir, d4T/3TC/nelfinavir, and ZDV/3TC/indinavir were randomised to continue therapy or switch d4T to ZDV and PI to ABC, such that the universal switch regimen was ZDV/3TC/ABC. Primary endpoints included percentage change from baseline in fat in the legs and arms in whole body DEXA scans at 24 and 48 weeks. Secondary endpoints were HIV RNA concentration, adverse events, abdominal fat in single-cut L4 CT scans, anthropometric and metabolic parameters. Results: At 48 weeks in intention-to-treat analysis, subjects who switched therapy to ZDV/3TC/ABC had a significant mean percentage increase from baseline in percentage of leg fat (+0.45) compared with a mean decrease (-0.45) in those who continued any of the baseline regimens (p=0.03, t-test). There was also an average increase in percentage of arm fat in the switch groups (+0.95 at 24 weeks,+1.73 at 48 weeks) compared with +0.02 at 24 weeks (p=0.05, t-test) and +0.66 at 48 weeks (p=0.08, t-test) in the continue groups. The change from baseline in percentage of arm fat observed on those who switched both d4T and PI was significantly greater than that observed in those who switched PI alone or continued therapy (p=0.01, t-test). No subjects in the switch groups experienced virological failure. For metabolic parameters, there was a mean decrease in LDL cholesterol in those who switched away from indinavir containing regimens (p=0.03, t-test). Conclusions: Switching to ZDV/3TC/ABC maintained virologic control and was associated with objective evidence of fat sparing as well as some fat restoration, compared with continued d4T and/or PI therapy.

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