A cohort study of the food effect on virological failure and treatment discontinuation in patients on HAART containing didanosine enteric-coated capsules (FOODDIe Study).
BACKGROUND
Didanosine enteric-coated capsules (ddI-EC) should be taken under fasting conditions. However, the effect of food on the absorption of ddI-EC may not reduce exposure to the drug.


METHODS
We performed an observational study to assess the effect on virological failure of taking ddI-EC with food. To be included, patients had to have begun their first ddI-EC-containing HAART regimen between June 1, 2001 and June 1, 2003. Primary endpoints were virological failure or discontinuation of the ddI-EC-containing regimen.


RESULTS
668 patients were included (119 patients were naïve, 172 switched from a different regimen, and 377 were part of rescue therapy). 296 patients were taking ddI-EC with food. After 71 weeks of follow-up, 162 discontinued ddI-EC in the fasting group and 120 in the fed group. 46 patients had virological failure (19 without food vs. 27 in the group with food). Adherence to therapy >80% was 79.7%. We fitted a multivariate Cox proportional hazard model and found a significant interaction between ddI-EC intake and adherence. The multivariate model showed that when adherence to HAART was poor (<80% of prescribed pills) taking ddI-EC with food significantly increased the risk of virological failure (hazard ratio [HR] 8.32, 95% CI 1.67-41.65), but this disappeared when adherence was 80%-95% (HR 0.27, 95% CI 0.04-1.53) or >95% (HR 0.57, 95% CI 0.12-2.77).


CONCLUSIONS
When adherence is good (>80% of the prescribed doses), ddI-EC can be administered with food without an increase in virological failure or HAART discontinuation.
López
Juan Carlos
JC
Hospital Universitario Gregorio Marañón, Madrid, Spain. juanclopezbq@wanadoo.es
Moreno
Santiago
S
Jiménez-Oñate
Fernando
F
Clotet
Bonaventura
B
Rubio
Rafael
R
Hernández-Quero
Jose
J
D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D002214:Capsules; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D016049:Didanosine / Q000627:therapeutic use*; D005215:Fasting; D005260:Female; D005502:Food; D018565:Food-Drug Interactions; D006678:HIV / Q000302:isolation & purification; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D010349:Patient Compliance; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D012307:Risk Factors; D013030:Spain; D017211:Treatment Failure; D019562:Viral Load
D019380:Anti-HIV Agents; D002214:Capsules; D016049:Didanosine