Gilead Sciences, Inc. (NASDAQ:GILD) announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection met its primary objective. The ongoing study was designed to explore the efficacy and safety of F/TAF-based regimens among virologically suppressed adult patients switching from HIV treatment regimens containing emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (Truvada®). At Week 48, the F/TAF-based regimens and the TDF-based regimens achieved similar rates of virologic suppression based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL (94.3 percent for F/TAF-based regimens versus 93.0 percent for TDF-based regimens; difference in percentages: 1.3 percent, 95 percent CI: -2.5 percent to 5.1 percent).
Compared to the TDF-based regimens, the F/TAF-based regimens demonstrated statistically significant differences in mean bone mineral density (BMD) at the hip and spine (p<0.001) and in the median change in estimated glomerular filtration rate (eGFR) (p<0.001). General safety and discontinuation rates due to adverse events were comparable between the two arms. The most commonly reported adverse events included upper respiratory tract infection, diarrhea, nasopharyngitis, headache and bronchitis. Both regimens were generally well tolerated. Gilead plans to submit these data for presentation at a scientific conference in 2016.
“For more than a decade, Truvada has been a cornerstone of HIV therapy, and the results of this and other recent trials demonstrate the potential of F/TAF to become a next-generation backbone,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “The results from this study reinforce the efficacy, as well as the renal and bone safety advantages of TAF for patients who face a lifetime of treatment.”
In April 2015, Gilead filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for two fixed-dose combinations of F/TAF (200/10 mg and 200/25 mg), and the FDA has set a target review date under the Prescription Drug User Fee Act of April 7, 2016. A Marketing Authorization Application (MAA) in the European Union for F/TAF was fully validated on May 28, 2015.
TAF and TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
About the Study
The Phase 3 study is a randomized, double-blind clinical trial among 663 virologically suppressed adults (HIV-1 RNA levels < 50 copies/mL) on a stable regimen containing Truvada for ≥ six consecutive months. Patients were randomized 1:1 to either maintain their Truvada-based regimen (Truvada + placebo + third agent) or switch to an F/TAF-based regimen (F/TAF + placebo + third agent). The study will follow patients for 96 weeks after randomization. The daily dose of F/TAF in the trial was 200/25 mg; if used in combination with a protease inhibitor administered with either ritonavir or cobicistat, the daily dose was 200/10 mg.
The study is ongoing. The primary objective is to evaluate the efficacy of switching FTC/TDF to F/TAF versus maintaining FTC/TDF in HIV-1 positive subjects who are virologically suppressed on regimens containing FTC/TDF as determined by the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis. The secondary objectives are to evaluate the renal safety of the two regimens including estimated glomerular filtration rate (eGFR), and to evaluate the bone safety of the two regimens in hip and spine bone mineral density (BMD) at Week 48 and Week 96. (Original Source)
Shares of Gilead Sciences closed yesterday at $101.49. GILD has a 1-year high of $123.37 and a 1-year low of $85.95. The stock’s 50-day moving average is $113.80 and its 200-day moving average is $108.86.
On the ratings front, Gileadhas been the subject of a number of recent research reports. In a report issued on July 29, Piper Jaffray analyst Joshua Schimmer maintained a Buy rating on GILD, with a price target of $134, which represents a potential upside of 32.0% from where the stock is currently trading. Separately, on the same day, Morgan Stanley’s Matthew Harrison maintained a Buy rating on the stock and has a price target of $125.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joshua Schimmer and Matthew Harrison have a total average return of 0.4% and 7.6% respectively. Schimmer has a success rate of 38.9% and is ranked #2059 out of 3742 analysts, while Harrison has a success rate of 52.0% and is ranked #1100.
The street is mostly Bullish on GILD stock. Out of 17 analysts who cover the stock, 16 suggest a Buy rating and one recommends to Sell the stock. The 12-month average price target assigned to the stock is $123.47, which implies an upside of 21.7% from current levels.