Gilead Sciences have announced the FDA has approved its drug Epclusa (sofosbuvir/velpatasvir) following a Priority Review. Approved on June 28, the drug is designed to treat patients with chronic hepatitis C caused by all major genotypes (GTs) of the hepatitis C virus (HCV), including patients with both compensated and decompensated liver cirrhosis (Child-Pugh B or C). The approval of Epclusa comes off the back of encouraging feedback on its EU regulatory filling, with the European Commission recently granting marketing authorization. 

With Epclusa being the first pan-genotypic therapy for this disease, its licensure signals the beginning of a wave of innovative treatments for chronic hepatitis C. Additionally, experts at GlobalData expect that the drug could further streamline the treatment algorithm with a streamlined therapy selection process. As a single-pill, once-daily therapy with limited dependence on ribavirin co-administration, Epclusa is viewed as a much more simplified treatment for patients.

Furthermore, the addition of Epclusa, alongside blockbuster products, Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir),firmly cements Gilead’s place as the dominant force in the hepatitis C market. GlobalData believes the company will continue to dominate this arena as it ushers in the pan-genotypic era of hepatitis C treatment.

Chronic hepatitis C, which results from acute HCV infection, is one of the most prevalent viral diseases globally. While it is largely asymptomatic in most infected individuals, if left untreated, patients with chronic hepatitis C are at high risk of developing serious complications, including liver cirrhosis and hepatocellular carcinoma (HCC). Since 2013, the approval of next-generation direct-acting antivirals (DAAs), such as Gilead’s Sovaldi and Harvoni, and AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir + dasabuvir)—all of which capable of curing the large majority of patients with minimal side effects and reduced treatment duration—has fundamentally changed the nature of care for chronic hepatitis C, transforming it to a highly curable disease. As a result, next-generation DAAs have replaced interferon/ribavirin combinations, which suffer from low cure rates and very poor tolerability, as well as first-generation DAAs, Vertex’s Incivek (telaprevir) and Merck’s Victrelis (boceprevir). The fierce competition in this highly profitable market, which has re-written a few drug sales records, has been pushing continuous improvement of the efficacy, convenience, and patient coverage of therapies.

Epclusa is Gilead’s latest fixed-dose combination containing the company’s flagship DAA, sofosbuvir, which is the only approved nucleotide-based inhibitor of HCV NS5B nucleotide polymerase. The other active component of Epclusa, velpatasvir, is pan-genotypic inhibitor of the HCV NS5A protein. To support the filing and approval of Epclusa in the US and EU, Gilead conducted four pivotal Phase III clinical trials, known as the ASTRAL program. Importantly, these studies enrolled patients infected with all major HCV GTs (GT1–6), with or without liver cirrhosis, and regardless of previous treatment failure. Results from these studies showed that almost all patients who received a 12-week regimen of once-daily Epclusa achieved HCV clearance, as measured by sustained virologic response 12 weeks post-treatment (SVR12) rates. GlobalData outlines and analyzes the most recently published data in a separate Expert Insight, ILC 2016: Gilead Demonstrates High Efficacy of Sofosbuvir/Velpatasvir-Based Combinations in Diverse Hepatitis C Populations.

The primary advantage of pan-genotypic therapy for chronic hepatitis C is that physicians can be saved from choosing the best therapy to suit a patient’s disease and personal characteristics. This is particularly important for physicians less experienced in treating hepatitis C, and in geographic locations where tests on HCV genotype and liver condition are not easily accessible. GlobalData’s primary research also revealed that pan-genotypic activity also makes a drug more competitive with payers, who can reimburse one drug to cover all their patients, rather than having to make deals with multiple producers.

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Despite its first-in-class status, key opinion leaders (KOLs) interviewed by GlobalData were split on the prospective market success of Epclusa. Some believe its pan-genotypic activity will drive substantial uptake of Epclusa, to the point where it could replace Harvoni in the US and other developed markets. Nevertheless, because Epclusa’s improvements in efficacy and safety are marginal in the context of the larger patient pool—with highly successful drugs already in use for various GTs, particularly GT1—the drug is likely only be prescribed in patients groups in which it can bring the biggest improvement, or where there are currently limited treatment choices.

All KOLs emphasized that cost is the number one concern when choosing therapies at present. Indeed, when there is little room for competition in clinical performance, companies have been fighting on the marketing and sales fronts. In the US in particular, deals with payers play a major part in which drugs are reimbursed. Merck recently launched its fixed-dose combination, Zepatier (elbasvir/grazoprevir), in the US at a list price that was over 40% lower than that of Harvoni. Further analysis of pricing strategies in hepatitis C can be found in GlobalData’s Expert Insight: Merck’s Zepatier Poised to Challenge Harvoni for Supremacy in Hepatitis C.

In addition to competition from marketed drugs, Epclusa may also soon be compared with two more pan-genotypic therapies: Gilead’s own sofosbuvir/velpatasvir/GS-9857 combination, and AbbVie’s ABT-493/ABT-530 combination, which are both in Phase III of clinical development. In particular, AbbVie’s combination has produced stunning efficacy results, which are summarized in GlobalData’s Expert Insight: ILC 2016: Investigational AbbVie HCV Regimen Boasts High SVR Rates in Challenging Patients, and with Shorter Treatment. Currently, developers focus their R&D efforts on the remaining few clinical unmet needs, especially efficacy in challenging patient populations, such as those with GT3 HCV infection or decompensated liver cirrhosis. GlobalData believes Gilead’s clinical strategy and Epclusa’s performance in clinical trials put the product in a strongly competitive position.

Overall, GlobalData believes Epclusa is a highly credible product that starts the era of pan-genotypic hepatitis C treatment, and will become a strong competitor in the market. Gilead’s experience in marketing and sales of antiviral treatment, combined with its reputation and connections in liver diseases, will strongly assist the success of the product. Nevertheless, competition in the hepatitis C arena has changed drastically from when Gilead launched Sovaldi, so GlobalData doubts that any new product will dominate the treatment landscape in the foreseeable future.



*This article first appeared on GlobalData Expert Insights on June 29, 2016