AEGiS-Glasgow [PL2.5] Early virological failure in persons with viral loads > 100 000 copies/ml and CD4 counts < 200/mm<sup>3</sup> receiving didanosine(ddI)/tenfovir(TDF)/efavirenz(EFV): 12 week results from a randomised comparative trial

Seventh International Congress on Drug Therapy in HIV Infection

Glasgow, UK - 14-17 November 2004

[PL2.5] Early virological failure in persons with viral loads > 100 000 copies/ml and CD4 counts < 200/mm³ receiving didanosine(ddI)/tenfovir(TDF)/efavirenz(EFV): 12 week results from a randomised comparative trial

Int Cong Drug Therapy HIV 2004 Nov 14-18;7:Abstract No. PL2.5

D. Maitland , G. Moyle , J. Hand , M. Nelson , B. Gazzard
Chelsea and Westminster Hosptital, London, UK

To compare the efficacy, safety and subject adherence of two 'once daily' (QD) antiretroviral regimens in treatment na ve subjects.

A randomized open-label comparative trial evaluating tenofovir (TDF) + didanosine (ddI) 250mg + Efavirenz (EFV) administered QD with food (TDF group) versus lamivudine (3TC) + ddI 400mg + EFV taken QD fasted (3TC group).

77 subjects (median age 37, 67 male, 10 female) were randomised prior to the trial being prematurely stopped, 41 subjects to the TDF group and 36 to the 3TC group. The mean baseline VL and median CD4 were 5log₁₀ and 174/mm³ in the TDF group and 5 log₁₀ and 157/mm³ in the 3TC group. At week 12, 0/35 of the subjects in the 3TC group had a viral load greater than 1 000 copies/ml while in the TDF group 4/34 (11.8%) had seen a rise of >0.5log₁₀ from nadir or the emergence of resistance mutations in RT. All of the subjects who experienced incomplete viral suppression had a baseline CD4 <200/mm³ and viral load >100 000 copies/ml. Of the individuals with these baseline characteristics in the TDF group 4/15 (26%) had viral loads >10 000 copies/ml at week 12 compared to 0/18 in the 3TC group (p< 0.05). Emergent mutations included K103N (3), G190S (2), K65R (1), and L74I/V (2). Memscap data confirmed all failures were 100% adherent and food diaries confirmed that dietary restrictions were followed.

TDF/ddI/EFV as initial therapy appears to have diminished efficacy in subjects with baseline viral loads >100 000 copies/ml and CD4 counts < 200/mm³. Failure was not attributable to poor adherence.

SESSION 2: TREATMENT STRATEGIES AND ORAL PAPERS

2004-11-14
PL2-5

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