Phase 3 Data Support Switch From Truvada-Based Regimens to Descovy-Based Regimens in HIV Patients

Descovy demonstrates comparable efficacy

Two-year (96-week) data have been reported from a phase 3 study and 48-week data from two phase 3b studies evaluating the safety and efficacy of switching virologically suppressed patients infected with human immunodeficiency virus-1 (HIV-1) from regimens containing Truvada (emtricitabine and tenofovir disoproxil fumarate 200 mg/300 mg, Gilead Sciences) to regimens containing Descovy (emtricitabine and tenofovir alafenamide 200 mg/25 mg, Gilead Sciences). The results demonstrated that regimens containing Descovy were statistically noninferior to regimens containing Truvada, with improvements in certain renal and bone laboratory parameters among patients receiving Descovy-based regimens.

Descovy is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 12 years of age and older.

In Study 1089, 663 virologically suppressed, HIV-infected adults were randomly assigned to switch to regimens containing Descovy or to continue receiving regimens containing Truvada, while remaining on the same third agents. At week 96, virological suppression (HIV-1 RNA levels of less than 50 cells/mL) was maintained in 89% of subjects in both groups (difference in percentages: –0.5%).

In the same study, the effect of the two regimens on laboratory parameters of kidney and bone health was investigated. Statistically significant differences were observed in mean changes from baseline to week 96 in bone mineral density (BMD) between patients receiving Descovy-based regimens compared to patients receiving Truvada-based regimens (spine: +2.15% vs. –0.17%; hip: +1.85% vs. -0.33%; P < 0.05 for both). In addition, more patients receiving Descovy-based regimens experienced a greater than 3% improvement in BMD from baseline to week 96 compared with those receiving Truvada-based regimens (spine: 40% vs. 18%; hip: 29% vs. 11%; P < 0.05 for both).

Odefsey (rilpivirine 25 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, Gilead Sciences) is indicated as a complete regimen for the treatment of patients 12 years of age and older with HIV-1 infection who have no antiretroviral treatment history and HIV-1 RNA levels of less than or equal to 100,000 cells/mL. Odefsey is also indicated as a replacement for stable antiretroviral regimens in patients who are virologically suppressed (HIV-1 RNA levels of less than 50 cells/mL) for at least six months with no history of treatment failure and no known resistance to the individual components of Odefsey.

In Study 1216, 630 virologically suppressed, HIV-infected adults were randomly assigned to switch to Odefsey or to continue receiving Complera (rilpivirine 25 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, Gilead Sciences). At week 48, similar rates of virological suppression (HIV-1 RNA levels of less than 50 cells/mL) were maintained in both treatment groups (Odefsey, 94%; Complera, 94%; difference in percentages: –0.3%).

Statistically significant improvements favoring Odefsey were observed from baseline to week 48 in mean BMD at the hip and spine compared with patients in the Complera group (spine: +1.61% vs. +0.08%; hip: +1.04% vs. –0.25%; P < 0.001 for both). 

In Study 1160, 875 virologically suppressed, HIV-infected adults were randomly assigned to switch to Odefsey or to continue receiving Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, Bristol-Myers Squibb/Gilead Sciences). At week 48, high rates of virological suppression (HIV-1 RNA levels of less than 50 cells/mL) were maintained in both treatment groups (Odefsey, 90%; Atripla, 92%; difference in percentages: –2.0%).

Statistically significant improvements favoring Odefsey were observed from baseline to week 48 in mean BMD at the hip and spine compared with patients in the Atripla group (spine: +1.65% vs. +0.05%; hip: +1.28% vs. –0.13%; P < 0.001 for both). A larger percentage of patients receiving Odefsey showed improvements in their osteopenia or osteoporosis at either hip (P = 0.004) or spine (P < 0.001).

Source: Gilead Sciences; October 24, 2016.