Fw: NATAP/CROI: Raltegravir Body/Metabolics 96 Wks Results

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Modest

Lipid and Body Fat Changes With Raltegravir vs Efavirenz in 96-Week Trial

17th Conference on Retroviruses and

Opportunistic Infections, February 16-19, 2010, San Francisco

Mark Mascolini

Both raltegravir and efavirenz had a

modest impact on lipid readings after 96 weeks of a randomized trial in

previously untreated people, though average changes looked slightly better with

raltegravir [1]. People taking raltegravir or efavirenz had small gains in body

fat through 96 weeks, and almost no one lost limb fat.CROI: Metabolic Profiles and Body Composition Changes in Treatment-Naïve HIV-Infected Patients Treated with Raltegravir 400 mg bid-based vs. Efavirenz 600 mg qhs-based Combination Therapy: 96-Week Follow-Up - (02/20/10)

This double-blind trial involving 563

antiretroviral-naive people also taking fixed-dose tenofovir/emtricitabine

demonstrated virologic equivalence between the two treatment arms after 96

weeks, with about 80% in both groups having a viral load under 50 copies at

that point. The body fat substudy focused on 111 people at US sites who had

DEXA scans 48 and 96 weeks into the trial. Everyone was eligible for the lipid

substudy.

Before treatment began, age averaged 38 in the

raltegravir group and 37 in the efavirenz group, CD4 count averaged 219 and

217, and viral load averaged 100,000 copies in both groups. Most baseline

variables were similar in the two treatment arms among people in the DEXA

substudy. Median baseline body mass index was higher with raltegravir than

efavirenz in the overall group (25.8 versus 24.7 kg/m[2]), and in the DEXA

substudy there were fewer women randomized to raltegravir than efavirenz (7%

versus 16%).

Total cholesterol, high-density lipoprotein

(HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and glucose all

rose significantly more through 96 weeks with efavirenz than raltegravir (P < 0.001 for all lipids, P = 0.025 for glucose). Triglycerides climbed about

40% with efavirenz and declined slightly with raltegravir (P = 0.001). However, total/HDL cholesterol ratio

improved slightly in both groups (-0.18 with raltegravir, -0.04 with

efavirenz), with no significant difference between groups. Average total

cholesterol remained below the National Cholesterol Education Program (NCEP)

target in both treatment arms at 96 weeks, while average LDL cholesterol

readings were above the NCEP target of 100 mg/dL or lower with either

raltegravir (103 mg/dL) or efavirenz (114 mg/dL). After 96 weeks average

triglycerides measured 177 mg/dL with efavirenz and 121 mg/dL with raltegravir,

compared with an NCEP target of 150 mg/dL or lower.

Three of 37 people taking raltegravir (8%) and

2 of 38 taking efavirenz (5%) had at least a 20% loss in limb fat--defining

lipoatrophy--through 96 weeks. Most people in both treatment arms gained fat.

Average limb fat rose 18.2% with raltegravir and 17.0% with efavirenz. Average

trunk fat climbed 21.6% with raltegravir and 25.5% with efavirenz. Average body

mass index inched up 1.3 kg/m(2) with raltegravir and 1.0 kg/m(2) with

efavirenz.

Only 2 investigators reported clinical fat

abnormalities--1 "fat tissue increase" and 1

"lipoatrophy"--both in people taking efavirenz. The investigators

considered these changes mild.

All told, both regimens tended to improve fat

distribution in previously untreated people through 96 weeks of follow-up.

Raltegravir appeared to have a slight advantage over efavirenz in some lipid

measures, especially triglycerides, but the total/HDL cholesterol ratio

improved in both groups.

References

1. DeJesus E, Cohen

C, Lennox J, et al. Metabolic profiles and

body composition changes in treatment-naive HIV-infected patients treated with

raltegravir 400 mg twice-daily vs efavirenz 600 mg each bedtime combination

therapy: 96-week follow-up. 17th Conference on Retroviruses and

Opportunistic Infections. February 16-19, 2010. San Francisco. Abstract 720. http://www.retroconference.org/2010/PDFs/720.pdf.

2. Lennox JL, DeJesus E, Lazzarin A, et al.

Raltegravir demonstrates durable efficacy through 96 weeks: results from

STARTMRK, a phase III study of raltegravir-based vs efavirenz-based combination

therapy in treatment-naive HIV-infected patients 49th  ICAAC (Interscience Conference on Antimicrobial Agents and

Chemotherapy). September 12-15, 2009. San Francisco. Abstract H924b. http://www.natap.org/2009/ICCAC/ICCAC_12.htm.