Evolution of the biological follow-up of efficiency and tolerance of a once daily antiretroviral treatment with 3TC+DDI+EFV in children infected with HIV-1 (CLINICAL TRIAL ANRS 12 103)

Objective

To study the evolution of biological parameters of efficiency and tolerance of the anti retroviral treatment (3TC, DDI, EFV) in child.

Methods

A total of 52 HIV1 infected children have been included in the study and have receiving a once daily dose of Lamivudine, Didanosine and Efavirenz. The follow up biological parameters have been collected quarterly in a period of one year.

Results

The medium age was 6.83 years, with an age range of 2.5 to 14.5 years. The clinical stages at the enrolment were the following: 1 at stage N, 18 at stage A, 27 at stage B, 6 at stage C. At the biological level, the medium gain of CD4 in the children, after a period of one year of follow-up was of 14% (8.6% in inclusion). At the 12^th month of follow-up, 51% of the patients had an undetectable viral load (<50 copies/mL) and 78% (<300 copies/mL). The mean values of the biologic parameters in blood such as platelets, ALAT, bilirubine, the blood sugar, cholesterol, the triglycerid and the creatinine were always in the norms. Despite a meaningful increase to M12, the mean rate of haemoglobin was always inferior to the norms (10.60 ± 1.01 to M12). Regarding the biological perturbations, grade III or IV, it has been observed an increase of the transamisases in 1% of the patients and mainly an elevation of the amylasemia in 3.9%, 2%, 13.7% and 10% of the children respectively on M3, M6, M9 and M12.

Conclusion

The biologic tolerance and the efficiency of the treatment are satisfactory. The rate of haemoglobin, the transaminases, and the amylasemia appear to be the determining criteria for the follow-up of the moderate toxicity of this short-term treatment.