Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

February 17, 2016

In an on-treatment analysis, 99 percent of patients in Study 102 and 96 percent of patients in Study 103 who were originally randomized to receive Viread through 192 weeks achieved viral suppression below 400 copies/mL. Among those who were originally randomized to receive Hepsera, 100 percent of patients in Study 102 and 99 percent of patients in Study 103 achieved viral suppression below 400 copies/mL. In an analysis in which the addition of emtricitabine equals failure, 84 percent and 68 percent of patients (Studies 102 and 103, respectively) originally randomized to receive Viread and 87 percent and 72 percent of patients (Studies 102 and 103, respectively) originally randomized to receive Hepsera experienced sustained viral suppression. The majority of patients with elevated ALT at baseline achieved normalized ALT on treatment (ranging from 77 percent to 86 percent across both arms in both studies). Viread was well-tolerated in both studies. During the open-label period (week 48 through week 192), seven patients discontinued treatment due to an adverse event. Creatinine levels, an indicator of kidney function, remained stable through 192 weeks.

Patients with High Viral Load (Abstract 137)

In a subgroup analysis pooling data from Studies 102 and 103, 71 percent of patients who entered the trials with high viral levels (HBV DNA of at least 9 log10 copies/mL)>

Patients of Asian Descent (Abstract 481)

In another subgroup analysis pooling four-year data from Studies 102 and 103, 77 percent of Asian patients achieved sustained viral suppression (163 patients entered the open-label study phase). Of seven Asian patients who added emtricitabine treatment during the study, four of six remaining on study had viral suppression at week 192. ALT levels normalized in 86 percent of Asians after 192 weeks on treatment. Of 65 HBeAg-positive Asian patients with week 192 serology results, 35 percent achieved HBeAg loss and 26 percent experienced HBeAg seroconversion. Viread was well tolerated among this group of patients. During the open-label phase of Viread treatment, serious adverse events occurred in 6 percent of Asian patients, while grade 3-4 laboratory abnormalities occurred in 15 percent. During the study, one Asian patient had a confirmed serum phosphorus level less than 2 mg/dL, which normalized by week 192, and another had a confirmed increase of at least 0.5 mg/dL in serum creatinine.

Treatment-Experienced Patients (Abstract 136)

In Study 106, Viread showed sustained efficacy in patients with prior Hepsera treatment experience through 168 weeks. Patients with an incomplete virologic response after receiving Hepsera for at least six months were randomly assigned to Viread>

The percent of patients achieving viral suppression (HBV DNA below 400 copies/mL) through 168 weeks was the same in both arms of the study at 82 percent. Additionally, 100 percent of patients with baseline resistance mutations to lamivudine (13/13 patients) and 90 percent of patients with baseline resistance mutations to adefovir (9/10 patients) achieved viral suppression. ALT normalization occurred in 68 percent of Viread and 67 percent of Truvada patients. Both Viread and Truvada were well tolerated, and no unexpected or clinically important adverse events related to renal function were reported among these treatment-experienced patients. Notably, no patient experienced a confirmed increase of at least 0.5 mg/dL in serum creatinine, calculated creatinine clearance less than 50 mL/min or serum phosphorus less than 2.0 mg/dL.

Source: Gilead Sciences, Inc.