Use of the protease inhibitor saquinavir hard gel in human immunodeficiency virus-infected patients in the early period of highly active antiretroviral therapy: does it affect long-term treatment outcome?

Saquinavir hard gel capsule (hgc), the first human immunodeficiency virus (HIV) protease inhibitor (PI) used in clinical practice, has been shown to have insufficient effectiveness. A population-based cohort study assessed the long-term consequences of using saquinavir hgc as initial PI in HIV-infected patients pre-exposed to nucleoside reverse transcriptase inhibitors. 121 patients starting a regimen with saquinavir hgc were compared with 91 starting with non-boosted indinavir ( n =72) or ritonavir ( n =19). Median follow-up time was 4.6 and 4.7 y for the 2 groups. Starting with saquinavir hgc was associated with a lower overall probability of achieving an undetectable viral load [risk ratio (RR)=0.41, 95% confidence interval (95% CI) 0.30-0.56]. However, the lower probability of having undetectable viral load during follow-up declined over time with odds ratios (OR)=0.27 (95% CI 0.14-0.54), 0.35 (95% CI 0.19-0.66), 0.47 (95% CI 0.24-0.91) and 0.73 (95% CI 0.34-1.55) at 60, 120, 180 and 240 weeks, respectively, after starting HAART. Starting with saquinavir hgc was correlated with a higher risk of having the initial PI discontinued (RR=1.89, 95% CI 1.39-2.58). The insufficient suppression of viral load in patients starting with saquinavir hgc subsided during follow-up, probably owing to the earlier discontinuation of saquinavir hcg in favour of newer and more potent HAART regimens.