Twenty-two studies were included in the review. Sixteen studies were classed as prospective trials (including six RCTs). Fourteen studies were in patients with suppressed HIV-RNA. Eight studies were in patients with unsuppressed HIV-RNA. Duration of follow-up varied considerably.
The analysis of intention-to-treat data from the RCTs showed a statistically significantly greater rate of therapy failure in those treated with ritonavir-boosted protease inhibitor monotherapy compared with those treated with highly active antiretroviral therapy (OR 1.48, 95% CI: 1.02 to 2.13, 6 RCTs). The as-treated analysis showed similar trends.
At the end of follow-up, the percentage of patients with undetectable HIV-RNA ranged from 33.3 to 90.0%; overall 67.9% patients had undetectable HIV-RNA based on the intention-to-treat analysis, with similar proportions reported for patients with suppressed and unsuppressed HIV-RNA at trial inception. Results of the as-treated analysis were also reported.
Fifty-eight of 570 patients experienced treatment failure; 10 of these patients had virological failure, experiencing major protease inhibitor mutations.