UT researchers report that they have successfully eradicated hepatitis C viral replication in 97 percent of patients using two new antiviral drugs known as sofosbuvir and ledipasvir. According to Professor Eric Lawitz of the University of Texas Health Science Center in San Antonio, who led the study, the results offered hope to people currently without treatment options: “The results of this trial suggest that the fixed-dose combination of sofosbuvir and ledipasvir could offer patients a short, all-oral treatment that might be highly effective and safe in patients who tend not to respond well to existing therapies, including individuals with cirrhosis, or black race, resistant strains of the virus”.
This raises hopes of a possible cure.
Unlike other forms of hepatitis, hepatitis C has no vaccine. Therapies involve powerful combinations of drugs known as interferons and protease inhibitors. These treatments are difficult to administer and they have many side effects. In the most common type of hepatitis C (genotype 1), the drugs don’t work. If infection continues, it can lead to liver cancer.
Researchers worked with 100 patients with genotype 1 hepatitis C. The patients were split into groups and given drugs in a single dose (sofosbuvir and ledipasvir) for either eight or twelve weeks. Of these patients, forty had previously failed to respond to drugs and half of that group had cirrhotic livers. After twelve weeks, researchers observed that 97 percent of the patients had a “sustained virological response”. This means that the hepatitis virus was not replicating inside their bodies. Side effects observed included nausea, anemia, respiratory tract infections and headaches. No side effects were deemed serious.
Charles Gore, chief executive of the Hepatitis C Trust, notes, “We were concerned that those with advanced hepatitis C would remain difficult to treat, but these new direct antivirals are incredibly potent. The results suggest that even the most difficult to treat people will in fact be extremely treatable. It now looks as if almost no one will be excluded from benefiting from treatment, which is an incredible achievement.”
Hepatitis C is found in blood, saliva, and semen or vaginal fluid of an infected person. This virus is most likely to be transmitted by way of blood-to-blood contact. Individuals using intravenous drugs who share their needles are particularly susceptible.
Professor Margaret Hellard of the Burnet Institute in Melbourne, Australia, who co-authored a linked comment on the research published in the Lancet, notes: “As a proof of concept study, [this] demonstrates very high response rates, regardless of the presence of cirrhosis, prior treatment failure, or [resistant] genotype.” However, Hellard forewarns that the sample size of the current study was small and based on a single location with a short follow-up. This raises some concerns about how representative the study is and whether these results can be used to generalize to the real-world arena. Although the outcome of this trial provides cause for optimism, the results should be tempered for now.
An official summary of the study can be seen on The Lancet.