Evidence Summaries

A Cochrane review ¹ included 3 studies with a total of 1,687 subjects. One trial compared Trizivir^® to efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor) plus two or three nucleoside reverse transcriptase inhibitors (NRTIs); the second trial compared Trizivir^® to a treatment based on the protease inhibitor (PI) nelfinavir; and the third compared Trizivir^® to atazanavir (a PI) plus two NRTIs.

Overall, there was no significant difference in the incidence of virological failure between participants on Trizivir^® and those on PI-based or NNRTI-based therapy (three trials, N=1,687; RR 1.14, 95% CI 0.56 to 2.32). However, there was significant heterogeneity between the results of the three trials (heterogeneity P=0.009, I2=79%), with a significant increase in virological failure for Trizivir^® compared to efavirenz (N=1,147; RR 1.93, 95% CI 1.46 to 2.55) but no difference between Trizivir^® and PIs (two trials, N=540; RR 0.82, 95% CI 0.50 to 1.36). No significant differences were found between Trizivir^® and either the PI or NNRTI on CD4+ cell counts (standardized mean difference -0.01, 95% CI -0.11 to 0.09), severe adverse events (RR 1.41, 95% CI 0.61 to 3.25) and hypersensitivity reactions (RR 4.04, 95% CI 0.41 to 40.02). Only the studies involving PIs reported the effect of the treatment regimens on the lipid profile. One study found that at 96 weeks, the mean increase in total cholesterol from baseline was significantly lower with Trizivir^® than with nelfinavir, but there were no significant differences with triglyceride levels. The second study found the fasting lipid profile to be comparable in both the Trizivir^® and atazanavir arms at 48 weeks.

Comment: The evidence is downgraded by study quality (inadequate or unclear allocation concealment).

References