Tenofovir Approved for First Line Therapy in Adults

Tenofovir disoproxil/tenofovir (Viread) is a nucleotide HIV reverse transcriptase inhibitor. Previously recommended for second-line treatment in case of virological failure, it is now approved for first-line therapy in adults.

This license extension is based on a double-blind trial comparing tenofovir + lamivudine (Epivir) + efavirenz (Sustiva) with stavudine (Zerit) + lamivudine + efavirenz in 602 patients.

After 96 weeks, three-quarters of patients had undetectable viral load (<50 copies/ml), and there was no statistically significant difference among the groups.

The number of serious adverse effects was similar in the two groups. Relative to the stavudine combinations, there were fewer reports of lipodystrophy (1% versus 12%), fewer peripheral neuropathies (3% versus 10%) and fewer prescriptions of lipid-lowering therapy (2% versus 10%) among patients taking tenofovir.

Tenofovir seemed to have a worse effect on renal function and bone metabolism, however.

Tenofovir is taken only once a day, but so are didanosine and lamivudine.

The authors [not listed] conclude, “In practice, there is not yet enough evidence to support the routine use of tenofovir in first-line antiretroviral combinations. Tenofovir is, however, an interesting alternative when stavudine is poorly tolerated.”

10/29/04