Long-term response to FTC in children is similar to adults
Paul E Sax, MD, The Body
Gilead Study FTC-203 is an ongoing, open-label study designed to evaluate the antiviral activity of FTC (emtricitabine, Emtriva) in combination with other antiretroviral drugs in pediatric patients.
Study subjects received FTC at a dose of 6 mg/kg/day up to a maximum dose of 200 mg a day; either an alcohol-free oral solution or capsules were used. If treatment naive, the patient also received stavudine (d4T, Zerit) and lopinavir/ritonavir (LPV/r, Kaletra); if treatment experienced and receiving lamivudine (3TC, Epivir), the patient was given emtricitabine in addition to his or her other antiretrovirals.
A total of 71 naive and 45 experienced patients were enrolled. The mean age was 6 years old; the median HIV RNA was 4.5 log with a CD4+ cell count of 826. Fifty-three percent of the study participants were female and 69% were black. The proportion of patients achieving viral suppression at week 96 was as follows:
% patients achieving VL below 50 or 400 copies at 96 weeks
|VL||Naive pts||Experienced pts|
The only mutation to emerge among treatment-naive study subjects was M184V, the signature mutation of FTC. No data on tolerability was presented.
The results of this study suggest that FTC in pediatric patients achieves comparable antiviral activity to FTC in adults. As noted in adult studies of lopinavir/ritonavir with 3TC or FTC plus a third nucleoside/nucleotide reverse transcriptase inhibitor, the most likely mutation to emerge with treatment failure is M184V.
The preliminary data for FTC in children appears to be encouraging.
This study will hopefully hasten licensing and accessibility to FTC for children, which will provide an additional option for once daily combinations.
FTC liquid formulation is currently available in the UK on a named patient basis by contacting Rachel Hutchings at the medical department at Gilead Sciences on 01223 897345.
Harris J et al. Long-term virologic response and genotypic findings in HIV-1 infected pediatric patients receiving emtricitabine (FTC) once daily (QD). 41st ICAAC, Washington, 2004. Poster H-855.