The annual International Liver Congress, a major scientific meeting run by the European Association for the Study of the Liver (EASL), brings together the brightest minds in the field to examine progress in liver disease research. This year’s EASL meeting, which took place in Amsterdam from April 19 through 23, focused on advancements in treating hepatitis C virus (HCV) and non-alcoholic steatohepatitis (NASH), as well as findings about hepatitis B virus (HBV).
Below is a quick summary of major findings presented at the conference. To read about any of the studies in greater detail, click the hyperlinks.
Hep C Treatment:
A couple of notable studies highlighted some of the considerable benefits of curing hep C.
In one study of people with hep C and decompensated cirrhosis (the more advanced form of the liver disease) who were on the liver transplant waiting list, about a quarter were removed from the list thanks to improvements in their condition. Another study found that curing HCV reduces the risk of cardiovascular disease among those with compensated cirrhosis (the milder form of cirrhosis).
Numerous studies fleshed out details about AbbVie’s combination-tablet treatment for all genotypes, glecaprevir/pibrentasvir. Known as G/P, the regimen is currently up for FDA approval, with a decision expected in late June. Among those with genotypes 1, 2, 4, 5 and 6 and compensated cirrhosis, 12 weeks of G/P boasted a 99 percent cure rate. An eight-week course of G/P cured 95 percent of those with hard-to-treat genotype 3 who were first-timers to treatment and did not have cirrhosis. And among people coinfected with HCV and HIV, G/P led to a cure rate of 99 percent among those with cirrhosis, who were treated for 12 weeks, and 93 percent among those without cirrhosis, who were treated for eight weeks.
On Merck’s slate, Zepatier (grazoprevir/elbasvir) cured 96 percent of a group of veterans with genotype 1 or 4, a considerable proportion of whom had other health and mental health conditions, such as diabetes, depression and HIV. Also, in a study of the company’s experimental grazoprevir/uprifosbuvir/ruzasvir among people with genotype 1 who had failed a previous hep C treatment, 98 percent of those who received the triple-drug treatment with ribavirin for 16 weeks were cured, as were 100 percent of those treated for 24 weeks with just the triple-drug regimen.
Janssen and Achillion’s joint venture of the experimental three-drug regimen of Olysio/odalasvir/AL-335 cured all 40 people with genotype 1 who were treated for six or eight weeks in one study. The companies have moved this regimen into Phase III trials, testing both treatment lengths.
Gilead Sciences, the reigning leader in hep C drug sales, posted disappointing results related to its experimental sofosbuvir/velpatasvir/voxilaprevir regimen. Eight weeks of the triple-drug combo failed to work as well as 12 weeks of the company’s Epclusa (sofosbuvir/velpatasvir) among people with all six major genotypes of HCV, including those with and without cirrhosis. However, the eight-week experimental treatment did show comparable efficacy to 12 weeks of Epclusa among those with genotype 3 and cirrhosis (this demographic was excluded from the other study of the regimen). On the brighter side, Gilead’s Harvoni (ledipasvir/sofosbuvir), which was just approved for pediatric treatment among those 12 to 17 years of age, cured 99 percent of children between the ages of 6 and 11 who had genotype 1, 3 or 4.
Gilead recently released an updated version of its key antiretroviral Viread (tenofovir disoproxil fumarate, or TDF), known as Vemlidy (tenofovir alafenamide, or TAF) when used for hepatitis B virus (HBV) treatment. A growing body of research has found that TAF is safer for the bones and kidneys when used in treatment for HIV. In a 96-week study presented at EASL, researchers found that the drug conferred the same benefit to people with HBV who switched their hep B treatment from Viread to Vemlidy. The switch also led to improvements in liver enzyme levels.
On a more worrisome front, another study found that individuals over 50—especially men— who have cleared hepatitis B still have a raised cancer risk.
An experimental liver cancer treatment involving radioactive beads unfortunately did not show a survival benefit over standard treatment. However, it did improve quality of life. Recipients of the treatment felt better overall and experienced fewer serious adverse health events compared with the current standard of care.
Another study found no difference in liver cancer rates between those cured of HCV with interferon and those cured with modern direct-acting antivirals (DAAs). While on the whole, curing hep C does indeed lower the risk of liver cancer, this study suggests that differences in the type of HCV treatments don’t apparently contribute to that risk.
Non-alcoholic steatohepatitis (NASH) took on a more central role at this year’s EASL, with multiple drug trials showing promise in treating this form of fatty liver disease.
Researchers modified versions of other NASH drugs to yield greater success in treating the condition. Twelve weeks of a retooled version of the NASH drug FGF19, called NGM282, led to a considerable drop in liver fat compared with a placebo. In another trial, researchers tested a revised version of the drug FGF21, called BMS-986036. Sixteen weeks of treatment bested a placebo in reducing liver fat as well as in improving indicators of fibrosis, metabolic parameters and liver injury.
A small proof-of-concept study of Gilead’s GS-0976 found that 12 weeks of the treatment among 10 people with NASH was associated with a 29 percent drop in their hepatic de novo lipogenesis (DNL), an indicator of the health of one of the liver’s metabolic pathways. The treatment was also linked to declines in liver fat and stiffness.
Another study found that liver fat itself is not likely the true culprit behind the progression of NASH-related disease in the liver. Instead, fibrosis, or scarring, of the organ predicts whether the disease will progress.
Troublingly, a new World Health Organization (WHO) report found that the annual global death rate related to hepatitis B and C—approximately 1.34 million people died from viral hepatitis in 2015—rivals those of HIV and tuberculosis (TB). The HBV/HCV mortality rate is set to worsen while fewer people are dying of TB and HIV each year.
The good news is, there are now highly effective drugs that can cure hep C and treat hep B. But diagnosing all those with either virus is a major hurdle, as is providing them with therapies that can be highly expensive. One study presented at EASL examined the effectiveness of cheaper, imported generic versions of hep C drugs, which offered high levels of success comparable to brand-name equivalents.