Artificial intelligence (AI) centric clinical solutions company Phesi reports its researchers have analyzed data from 209,860 hepatitis B (HBV) and C (HCV) patients, from 940 trial arms/cohorts, with the goal of building a picture of the “typical” patient and identify patient demographics. Leaders at the company have surmised that while the world’s infectious disease specialists have been focused on COVID-19 solutions, they now should set their sights on applying lessons learned on other pandemics, including hepatitis.
Gen Li, Phesi president, spoke to Outsourcing-Pharma about the analysis, the deadly impact of hepatitis, and why the world should focus on coming up with treatments. While the World Health Organization (WHO) goal of eradicating hepatitis by 2030 is within reach, he said, it will take hard work and focused collaboration.
“If industry works collectively, then yes, we will be able to achieve the WHO goal, but it will require regulators, sponsors, and biopharma organizations to collaborate more closely over the use of data,” he said. “We really need to think hard about the lessons learned from the COVID-19 pandemic, where we collaborated beautifully to produce multiple vaccines in record time.”
While COVID-19 has understandably held the spotlight among the world’s infectious diseases for the past several months, hepatitis remains a significant public health crisis. About 14% of all infectious and parasitic diseases are due to hepatitis, with an estimated 296m people worldwide living with HBV and 58 million worldwide are living with HCV.
Li added that the repository of data, much of it already in hand, can serve as a powerful resource in fighting hepatitis and other conditions.
“There is a wealth of patient data available – including historical trial data and electronic patient records – from which we can draw insights to design better clinical studies,” he pointed out. “This will let us ensure that the patient populations of trials to research new therapies and potential cures for hepatitis are truly representative of the patients this disease impacts across the world.”
What’s more, Li said, new treatments are in process, and the industry has seen “revolutionary advances” in the development of potential therapies.
“Direct-acting antivirals for HCV such a sofosbuvir/sofosbuvir-based regimens that have shown cure rates of more than 90%; this means the patient demographics are changing just as rapidly as therapies advance and there have already been significant shifts in the last three years alone,” he said. “Taking a dynamic data-driven approach allows us to maximize impact from innovative products.”
Li stated that the analysis of data from the 200,000+ hepatitis patients could benefit trials in numerous ways, including helping in the development of inclusion and exclusion criteria for new studies and offering a wealth of other insights.
“The analysis uncovered a number of differences between HBV and HCV patients. While hypertension and diabetes are the most common comorbidities, there is a significantly larger portion of HBV patients with diabetes (21%) and hypertension (51%), compared to HCV (11% and 27% respectively),” Li revealed. “Increased awareness of differences such as these between patient populations will assist with better, more targeted trial design.”
Paul Chew, chief medical officer with Phesi, advised the industry should take swift action to pursue effective, affordable treatments for hepatitis and other infectious diseases.
“This can only be done through a data-led approach and by applying the lessons of COVID-19 R&D,” Chew said. “Our analysis illustrates a number of comorbidities associated with hepatitis and outlines the typical patient for each of these diseases; the industry needs to draw on this data and take advantage of it to make treatments available and accessible for all in need across the globe.”