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news.Gilead Sciences has announced preliminary study findings showing that its HIV drugs Viread and Emtriva, plus Bristol-Myers Squibb's Sustiva, were able to better manage viral load than GlaxoSmithKline's Combivir plus Sustiva.
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The preliminary 48-week data is from Gilead’s Study 934, a phase III trial designed to compare a regimen of Viread (tenofovir disoproxil fumarate), Emtriva (emtricitabine) and Sustiva (efavirenz) to Combivir (lamivudine 150mg/zidovudine 300mg) and Sustiva in treatment-naive patients with HIV.
Results from this analysis of 487 patients show a statistically significant difference favoring Viread/Emtriva in the percentage of patients who achieved and maintained HIV RNA less than 400 copies/mL at 48 weeks, based on the FDA time to loss of virologic response algorithm (TLOVR).
Based on the 48-week analysis, data show 84% of patients in the Viread/Emtriva arm, compared to 73% of patients in the Combivir arm, achieved and maintained HIV RNA less than 400 copies/mL at week 48. Similarly, 80% of patients in the Viread/Emtriva arm, compared to 71% of patients in the Combivir arm, achieved and maintained HIV RNA less than 50 copies/mL at week 48.
Patients receiving Viread/Emtriva had a significantly greater increase from baseline in CD4 cell count at week 48 compared to those receiving Combivir. The incidence of adverse events leading to permanent discontinuation of study regimen was 4% in the Viread/Emtriva arm and 9% in the Combivir arm.
On August 2 last year, the FDA granted accelerated marketing approval of Truvada, a fixed-dose combination of Emtriva and Viread, while on December 20, Gilead and Bristol-Myers Squibb announced the establishment of a US joint venture to develop and commercialize a once-daily fixed-dose combination of Truvada and Sustiva.
Truvada, Viread and Emtriva work by blocking reverse transcriptase, an enzyme crucial for viral replication. By interfering with the replication process, these drugs, when combined with other anti-HIV medications, can help lower the amount of HIV or “viral load” in a patient’s body and increase the number of immune system cells (called T cells or CD4 cells).