Hydroxyurea plus Didanosine as Maintenance Therapy for HIV-Infected Patients on Long-Term Successful Highly Active Antiretroviral Therapy

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Abstract
Background: Toxicity and quality of life issues have moved to delay the initiation of highly active antiretroviral therapy (HAART) and to explore novel treatment strategies for HIV infection. The switch to simpler regimens or treatment discontinuation has been attempted with limited success. The combination of hydroxyurea (HU) plus didanosine (ddI) is a simple regimen that might be able to restrain virus replication for long periods of time and could be an acceptable option as maintenance therapy in patients on prolonged successful HAART. Method: The combination of HU (500 mg bid) plus ddI (400 mg qd) was offered to participants with viral load (VL) 350 cells/μL for more than 6 months under HAART. The prior HAART regimen was resumed if VL rose to >5,000 copies/mL and/or the CD4 count fell to p < .001), while those with hypertriglyceridemia fell from 36% to 21% (p < .05). Significant improvements in lipohypertrophy and lipoatrophy were observed in 52% and 64% of participants, respectively. Grade 3-4 toxicities appeared in 20 patients (11%), including 3 cases of pancreatitis and 1 of peripheral neuropathy. Prior history of VL >5 log, CD4 counts <200 cells/μL, and ddI experience were independently associated with lower response to HU + ddI maintenance therapy. Conclusion: The combination of HU + ddI may be a satisfactory maintenance therapy for more than half of patients on successful HAART who want to alleviate drug-related toxicities and/or pill burden. Patients with metabolic and/or body-shape abnormalities might particularly benefit from switching to this simple regimen.