[51] BASELINE (BL) LACTATE LEVELS AND CT SCAN VALUES PREDICT THE REGRESSION OF LIPOATROPHY (LA) IN CT SCAN 48 WEEKS AFTER A SWITCH FROM STAVUDINE (D4T) TO ABACAVIR (ABC) OR ZIDOVUDINE (ZDV)

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] BASELINE (BL) LACTATE LEVELS AND CT SCAN VALUES PREDICT THE REGRESSION OF LIPOATROPHY (LA) IN CT SCAN 48 WEEKS AFTER A SWITCH FROM STAVUDINE (D4T) TO ABACAVIR (ABC) OR ZIDOVUDINE (ZDV)

[AUTHOR(S):] J Hernandez¹, D Ward², V Williams¹, G McComsey³, T File⁴, T Lonergan⁵, S Hessenthaler¹ and R Fisher¹
¹GlaxoSmithKline, RTP, NC, USA; ²Dupont Circle Physicians Group, Washington, DC, USA; ³Case Western Reserve, Cleveland, OH, USA; ⁴Summa Health System, Akron, OH, USA; and ⁵UCSD Antiviral Research Center, San Diego, CA, USA

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 51
Antiviral Therapy 2003; 8(Suppl. 1):S196

[ABSTRACT:] Background: Compared to other NRTIs, d4T has been associated with an increased risk of LA and hyperlactatemia (HL). The TARHEEL study showed regression of LA and HL when d4T was replaced with ABC or ZDV in symptomatic subjects.

Methods: Subjects with HIV-1 RNA <400 c/ml on d4T-based regimens for (6 months, with LA, symptomatic HL or both had CT scans and DEXA to assess LA changes. Logistic regression analysis was used to identify predictors of LA regression at 48 weeks.

Results: Of 118 subjects, 86 replaced d4T with ABC and 32 with ZDV at BL. DEXA results showed median increases in actual (grams) and percent changes from BL: arms (239, 35.3%), legs (269, 12.0%) and trunk (859, 16.4%). CT Scan findings confirmed DEXA results. Median increase in subcutaneous abdominal tissue (SAT) was 4% and median decrease in visceral abdominal tissue (VAT) was 2%. 79% of subjects increased SAT and 54% decreased VAT. ABC and ZDV subgroups independently demonstrated positive changes in regional body fat. Increases in BL lactate [odds ratio (OR): 2.375, P=0.021], AST levels (OR: 1.022, P=0.034) and VAT (OR per 10 cm²: 1.105, P=0.006) were predictive of a decrease in VAT in CT scan. Each unit increase in BL lactate was also predictive of an increase in trunk fat in DEXA (OR: 2.854, P=0.037). BL arm fat in DEXA approached significance in predicting LA regression (P=0.059). When the significant covariates were assessed together in the same model, BL lactate levels and BL CT scan values remained significant in predicting a decrease in VAT. Durations of prior ART, PI or d4T therapy, age, gender, race, CD4 cell count, CDC classification and other BL laboratory parameters (cholesterol, triglycerides, or ALT) were not predictive of response.

Conclusions: Subjects with LA showed progressive gains in body fat through wk 48 when d4T was replaced with either ABC or ZDV. BL lactate levels and BL CT scan values were predictive of a decrease in VAT at 48 weeks.

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