PROSPECTIVE FOLLOW-UP OF 130 HIV-INFECTED PATIENTS 
TREATED EARLY WITH COMBINATION OF 2 NRTIS

Due to the concerns associated with taking HAART in terms of compliance, saving options, lipid abnormalities, and fat redistribution, I think the ICAAC organizers permitted the data from this study to be presented. In Geneva, questions were raised about when to start therapy and with what, because of adherence difficulties and the side effects (lipid abnormalities and fat redistribution). However, the only real alternative suggested in Geneva to PI therapy was NNRTI or triple NRTI therapy. Essentially, no one questioned that when you do decide to begin therapy, the goal should be to reduce viral load to <50 copies/ml. As you may know, European HIV treating doctors are sometimes more conservative, and some have them may have retained a leaning to want to start treatment with 2 NRTIs. This is directly opposed to the approach recommended by leading American doctors and that recommended by the PHS Guidelines for Treating HIV.

P Morlat from the Bordeaux University Hospital in Bordeux, France reported one year follow-up from an observational study of 130 patients with CD4s >350 treated with double NRTI combinations in the Aquitaine Cohort. Morlat stated his objective was to study the efficacy of double NRTI therapy in early disease. The patients in this study were treatment-naïve and enrolled between January 1996 and June 1997. The data was collected until March 31, 1998 and the analysis is intent-to-treat. The bDNA Chiron 500 copy test was used for testing viral load. A goal was to identify predictive factors for reducing viral load to <500 copies/ml. at one year.

Baseline Characteristics-CDC stage of disease group A: 79%; group B: 16%; group C: 5%. Basically, a relatively healthy group. Median CD4 count: 466 cells; median viral load 33,100 copies/ml. 96.2% had >500 copies/ml and 90.8% had >5000 copies/ml.

Participants received the following NRTI regimens-

• AZT+DDC 38%
• AZT+DDI 37%
• AZT+3TC 13%
• D4T+DDI 7%
• D4T+3TC 5%

Morlat reported a median follow-up of 14 months, there were 3 new AIDS cases, and 1 death. I think he may have reported the death was an unrelated event. The probability of remaining AIDS free after one year of therapy was 97%. After one year the median CD4 increase was about 80 cells (n=70). The median viral load reduction was about 1.6 log at month 2, and was about 1.5 log at month 12 (n=60).

• At month 2, about 54% had viral load <500 copies/ml (bDNA)
• about 30% had viral load between 500 and 5000 copies/ml
• At month 12, about 40-45% had <500 copies/ml and
• about 30% had between 500 to 5000 copies/ml.
• From the chart Morlat showed on a slide it appeared as if about 10-15% had viral load between 5,000 and 30,000 at month 12.
• At baseline about 50% had viral load above 30,000 copies/ml.
• At month two it appeared as though about 7% had viral load>30,000 copies/ml.
• At month 12, it appeared as though 10% had >30,000 copies/ml.

Baseline viral load was the only predictive factor significantly associated with reducing viral load <500 copies/ml. No specific baseline viral load could be identified for increasing probability of reaching <500 copies/ml. For individuals with <30,000 copies/ml at baseline, 53% were undetectable at one year. For individuals with >30,000 copies/ml, 40% were undetectable at one year. But, this was not statistically significant. PI therapy was introduced in France in 1997. Some of the study patients (7%) switched to HAART with a PI, but the percent was too low to effect these results. Morlat suggests that double NRTI therapy is an option for a subset of patients in early disease.