Background: In the Quest study, primary HIV infection (PHI) patients (pts) initiate HAART for ³ 18 months (mos), followed by randomization to 6 mos of HAART ± vaccine(s) before stopping treatment. This analysis describes treatment continuation rates and virological and immunological changes during the first 48 weeks (W) of follow-up (FU).

Methods: Subjects with £ 3 bands on Western Blot and positive viraemia started Combivir, abacavir, and amprenavir.

Results: We enrolled 148 subjects (mean age [range] 33.9 [20–58] yrs; 90% male; 72% homosexual risk group). Thirty-three (33) pts withdrew before W48 of whom 27 had stopped treatment. Of the 115 pts who remained under FU at W48, 12 (10%), 22 (19%), 80 (70%), and 1 (1%) were taking 0, 3, 4, and 5 drugs, respectively; 61 pts remained on the initial regimen. The cumulative percentage of pts stopping HAART by W48 was 28%, while 59% had made a change to the initial regimen (including stopping HAART). The table shows baseline values of virological and immunological parameters, and changes from baseline to W48, for the 115 subjects under FU.

At W48 VL was £ 50, £ 10 and £ 3 c/mL in 83%, 61%, and 44%, respectively, among subjects under FU (n = 114); 64%, 47%, and 34% using missing = failure (n = 148); 94%, 69%, and 50%, in an “on treatment” analysis (n = 100). Among pts who remained on treatment, W48 mRNA and DNA were £ 50 c/10⁶ PBMC in 87% and 56%, respectively, and £ 3 c/10⁶ PBMC in 37% and 12%. CD8/38++ level was < 20/mm³ in 32%. During FU, levels of CD8/38++, mRNA, and DNA were strongly associated with VL (using time-updated Cox models to predict VL< 3 c/mL, univariate HRs [95% CI] were 2.2 [1.3, 3.9], 1.4 [1.1, 1.8] and 1.9 [1.3, 2.6] per 1 log lower latest CD8/38++, mRNA, and DNA, respectively, p < 0.01).

Conclusions: Patient dropout rates were consistent with those of other PHI studies. HAART treated pts achieved a high rate of viral control as shown by levels of viremia, mRNA, DNA and CD8/38++ at W48. Further, FU will indicate whether integrated DNA will continue to decrease (3rd phase decay) with prolonged HAART.

 

Median [IQR]

	Baseline	Change (from baseline to W48)†
VL log c/mL	5.4 [4.9, 6.2]	-5.3* [-6.4, -3.8]
mRNA log c/106 PBMC	3.4 [2.9, 4.1]	-2.6* [-3.4, -2.0]
DNA log c/106 PBMC	2.8 [2.4, 3.0]	-1.1* [-1.6, -0.7]
CD4 /mm3	517 [399, 674]	+157 [0, 290]
CD4 %	26 [19, 35]	+12 [6, 19]
CD4/CD8 ratio	0.5 [0.3, 0.8]	+0.5 [0.3, 0.8]
CD8 /mm3	1035 [657, 1620]	-385 [-1035, -31]
CD8/38++ /mm3	460 [212, 966]	-417 [-1004, -145]

 ^†all p<0.001; *adjusted for assay limit