Combination therapy with hydroxyurea versus without hydroxyurea as first line treatment options for...

This study analyzed whether combination therapy with hydroxyurea (HU) could be considered as first line treatment for antiretroviral-naive patients.

The prospective open-label study was carried out from March 1996 to May 2000. The antiretroviral treatments were treatment 1-didanosine 400 mg/day, stavudine 60/80 mg/day, and HU 500 mg/day; treatment 2-two nucleosides plus a protease inhibitor; treatment 3-didanosine, indinavir, and HU (500-1,000 mg/day). The viral load (VL) and CD4 determinations were performed at weeks 24, 48, 72, and 96.

The sample comprised 284 patients. The distribution of patients by levels of VL and CD4 were similar in the three treatment groups. At week 24, patients receiving T1 and T3 achieved higher percentages of undetectable VL (89% and 81%, respectively) with no significant differences (p =.127) between them. The T2 group showed a lower proportion (58%) of undetectable VL, which was significantly lower than T1 (p <.0001) and T3 (p <.0007). At week 48, the results were similar to week 24. At week 96, nearly all patients had undetectable viral load (UVL). The analysis of adverse effects showed that the T2 group at week 48 had a greater proportion of adverse effects that was significantly different from T1 (p =.0026); T3 had intermediate values with no significant difference from T2 (p =.45) and from T1 (p =.048). At week 48, T1 showed higher adherence level with significant difference from the other two treatments.

Patients were followed for some 96 weeks and, with an intention-to-treat analysis, were found to do better virologically and Clinically in treatment groups containing HU. The combination of antiretroviral drugs with HU may be an excellent option as initial therapy because of its strong antiretroviral action, its lower rate of adverse effect, and the smaller cost as compared to other regimens.