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First results of the Narval trial (ANRS 088)

April 21, 2000

Patients with HIV infection may develop resistance to one or more of antiretroviral drugs to which they are exposed during treatment. The selection of the most appropriate drugs for switching therapy in patients who have developed resistance, is a difficult challenge. Both, genetic tests that identify mutations in viral genes associated with resistance, and phenotypic tests that measure viral sensitivity to drugs in vitro, have been developped. Only few data are however available at this time on the impact of using such tests on the virological response of patients exhibiting resistant viral strains who switch therapy.

The Narval trial (ANRS 088) was aimed at comparing, in patients who have failed a first line of protease inhibitors, the impact on plasma viral load of treatment switches based on genotypic or phenotypic assays for resistance, to that of a treatment prescribed by the physician in the absence of test for viral resistance.

The Narval trial took place between March 1999 and April 2000. It involved 541 patients who exhibited a viral load above 1000 copies by ml at baseline. The patients had previously been treated with at least one protease inhibitor - containing regimen. The patients were randomly assigned to one of three groups : switching therapy, based on the results a genotypic assay (G) ; switching therapy, based on the results of phenotypic assay (P) and a control group (C). The groups were comparable at baseline in terms of viral load, CD4 cell counts and previous exposure to antiretroviral drugs. Patients were assessed for virological efficacy of therapy at three months ( M3) and 6 months (M6) after the switch. All patients who exhibited virological failure at M3 (i.e. a decrease in viral load below one log) were tested for resistance. The impact of the switch was assessed using two criteria : number of patients with undetectable plasma viral load at M3 (below 200 copies by ml) (primary endpoint) and number of patients exhibiting more than one log by ml decrease in viral load.

At month 3 of the trial, there was no significant difference between the three treatments arms with regard to virological efficacy. An undetectable viral load was observed in 30% of the patients in group P, 41% of patients in group G and 34% of patients in group C. The percentage of patients who exhibited a significant decrease in viral load was also similar between the three groups, 55%, 59% and 51% respectively.

By analyzing the 427 patients who had reached month 6 in the trial, it became apparent, however, that the percentage of individuals in whom viral load reached undetectability at both M3 and M6 was significantly higher in patients in whom the treatment switch had been based on a genotypic resistance assay (29%), as compared with the phenotype group on 22% and the control group (17%). Results in the phenotypic assay arm were not significantly different from those in the control group.

The Narval trial will continue for another six months to investigate where the benefit that was seen at M6 in the patients in whom switch of therapy was guided by the genotypic resistance assay, persists. Further analyses are ongoing to identify patients in whom resistance assays are likely to be the most beneficial.

Agence nationale de recherches sur le sida (ANRS)

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