320   Once-a-Day Treatment for HIV Infection: Final 48-Week Results.

F. Maggiolo*¹, M. Migliorino², R. Maserati³, L. Rizzi³, A. Pan⁴, M. Rizzi¹, A. Callegaro¹, and F. Suter¹.
¹Gen. Hosp., Bergamo;²Gen. Hosp., Busto Arsizio;³Univ. of Pavia; and⁴Gen. Hosp., Cremona, Italy.

Background:Adherence is a critical variable for the success of anti-retroviral therapy; however, complicated therapeutic daily schedules are often needed and reduce adherence.

Methods:We evaluated in a prospective, clinically based study a simple once-a-day regimen with didanosine (300 mg once daily) + lamivudine (300 mg once daily) + efavirenz (600 mg once daily). All medications were taken together at bedtime or in another suitable moment of the day. Analysis was performed according to the intention-to-treat approach.

Results:Seventy-five naive patients were enrolled. Their mean age was 37.5 years, and 78.6% were males. Sixteen subjects had a previous diagnosis of AIDS, and 41.3% of the patients were HCV positive. At baseline the median HIV RNA was 123,000 copies/ml (range 6,520 to 1,570,000) and the mean CD4 T-cell count was 251 cells/mcl (SD 216 cells/mcl). After 4 weeks of therapy the median HIV-RNA value dropped to 399 copies/ml (range from <50 to 289,000). At 16; 32 and 48 weeks of therapy, 71.4; 78.4 and 78.3% of the patients had a viral load below the limit of detection (50 copies/ml), respectively. In the meantime a mean increase of CD4 T-cells from 251 to 467 cells/mcl was observed. Results were comparable in patients with a baseline viral load higher or lower than 100,000 copies/ml. Fourteen patients interrupted treatment because of virological inefficacy (4), side effects (rash, 2; GI discomfort, 2; hallucinations, 1; dizziness, 1), death (stroke, 1) or patient will (3 cases). One patient developed hyper-triglyceridemia after 8 months but did not interrupt therapy.

Conclusions:Once-a-day therapy is well accepted by the patients. The regimen we studied reduces the pill burden and the stress of a complicated daily schedule. It also allows a directly observed therapy (DOT) that in our casuistry was performed in 13 patients. The treatment shows a high potency, inducing a median reduction of viral load greater than 3.4 logs and a sustained suppression of viral replication in 78% of patients for up to one year. The treatment is generally well tolerated.