To: Izzy who wrote (4980 ) 7/26/1998 1:05:00 PM From: Oliver & Co Respond to of 6136
"Maintenance Therapy After Quadruple Induction Therapy in HIV-1 Infected Individuals: Amsterdam Duration of Antiretroviral Medication (ADAM) Study" Lancet (07/18/98) Vol. 352, No. 9123, P. 185; Reijers, Monique; Weverling, Gerrit; Jurriaans, Suzanne; et al. ÿÿÿÿ Even though evidence suggests that highly active antiretroviral therapy (HAART) improves the condition of patients infected with HIV-1, long-term use of combination drug therapies is often difficult to sustain because of patients compliance and the risk of toxicity.ÿ In a randomized open-label study, researchers assessed the efficacy of using induction therapy followed by maintenance therapy with HAART.ÿ Beginning in March 1997, researchers recruited patients infected with HIV-1 who had not previously used antiretroviral drugs and with at least 200 CD4 cells/microL and at least 1,000 HIV-1 RNA copies/mL in plasma.ÿ After 26 weeks of induction therapy with stavudine, lamivudine, saquinavir, and nelfinavir, patients were randomly assigned maintenance therapy with either stavudine and nelfinavir or saquinavir and nelfinavir, or were assigned continued induction therapy.ÿ Randomization was halted in February 1998 after an interim analysis, and 62 patients had been enrolled.ÿ Of the 43 patients who were followed up for 26 weeks, 39 exhibited a undetectable plasma HIV-1 RNA concentration at week 16.ÿ Thirty-one patients were randomly assigned treatment at 26 weeks, and 25 of these had a total follow-up of at least 36 weeks.ÿ At week 36, 64 percent of patients on maintenance therapy showed a detectable level of HIV-1 RNA, compared to 9 percent of the patients on continued induction therapy.ÿ In five patients on maintenance therapy with a prolonged undetectable plasma HIV-1 RNA concentration, the initial virion-clearance rate was higher at week 36, compared to nine patients with recurring detectable plasma HIV-1 RNA concentration.ÿ Even though the induction therapy quickly suppressed viral replication to below 50 copies/mL, the effects was not sustained in several patients who switched to maintenance therapy.ÿ The researchers do not recommend switching from induction therapy to maintenance therapy in daily practice.