New drug combination offers hope to patients with currently untreatable Hepatitis C

November 5, 2013, Lancet

Hepatitis C is a viral infection which, if left untreated, can lead to severe and potentially fatal liver damage. Existing treatments consist of a combination of drugs, usually ribavirin, pegylated interferon and a protease inhibitor, which together inhibit viral replication and enhance the body's immune response to eradicate the virus. These drugs can place a substantial burden on the patient, with complicated pill and injection regimens, which can last for up to 48 weeks, and unpleasant side-effects for some patients, including anaemia, depression, and loss of appetite.

Although C can be curable, different genetic strains of the virus respond differently to drug treatment, and a significant number of patients with genotype 1 hepatitis C (the most common strain of the virus in the United States and Europe) do not respond to existing treatments. Patients whose infection cannot be cured run the risk of sustaining substantial damage to their livers (such as cirrhosis), and patients in this group currently have no further treatment options.

A team of researchers from the Texas Liver Institute in San Antonio, Texas, USA, and Gilead Sciences, Inc., a biopharmaceutical company based in Foster City, California, USA, recruited 100 patients with genotype 1 hepatitis C virus who had either never received treatment (60 patients), or who had been treated unsuccessfully using existing drugs (40 patients). Of patients in the latter group, just over half (22, 55%) had cirrhosis.

All trial participants took a new combination pill consisting of the investigational drugs sofosbuvir and ledipasvir. Patients took the combination pill for either 8 weeks or 12 weeks, and some patients in the study also received ribavirin as part of their regimen. Participants were stratified into different groups according to whether they had previously received treatment for hepatitis C, their length of treatment, and whether they received the new alongside ribavirin or not.

At 12 weeks following the completion of therapy, nearly all (97 or 97%) of the patients in the study had achieved a sustained virological response (SVR) – essentially a functional cure for hepatitis C, where the virus is eliminated, and prevented from replicating.

Just under half of the patients in the study experienced at least one adverse event, with the highest rates observed in the groups of patients who were receiving ribavirin as part of their treatment regimen. No patient in any group discontinued treatment because of an adverse event.

According to Professor Eric Lawitz, of the Texas Liver Institute, who led the study, "To our knowledge, this trial is the first to report data for cirrhotic genotype 1 hepatitis C patients who did not respond to prior treatment with a regimen, a population without treatment options at present. 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 who tend not to respond well to existing therapies, including individuals with cirrhosis or black race, resistant strains of the virus, and those who have not responded to standard-of-care regimens that include protease inhibitors."

According to Professor Margaret Hellard, of the Burnet Institute, Melbourne, Australia, co-author of a linked Comment, "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, this was a small, single-centre study with only short follow-up, raising concerns about the representativeness of the sample and whether early clinical trial results can be easily generalised to real-world settings. Whilst giving cause for optimism, the full implications of these results need to be tempered for now."

Explore further: Studies of experimental hepatitis C drug show promise for preventing recurrence in liver transplant

More information: www.thelancet.com/journals/lan … (13)62121-2/abstract

Related Stories

Studies of experimental hepatitis C drug show promise for preventing recurrence in liver transplant

October 31, 2013
New drug therapies offer promise to some hepatitis C sufferers whose transplanted livers are threated by a recurrence of the disease, including some patients who have had no treatment options.

Investigational oral regimen for hepatitis C shows promise in NIH trial

August 27, 2013
In a study of an all-oral drug regimen, a majority of volunteers with liver damage due to hepatitis C virus (HCV) infection were cured following a six-month course of therapy that combined an experimental drug, sofosbuvir, ...

Interferon-free therapies for hep C virus look promising

January 3, 2013
(HealthDay)—For untreated patients with hepatitis C virus (HCV), treatment with an oral nucleotide inhibitor of HCV polymerase, sofosbuvir, plus ribavirin seems effective for genotypes 1, 2, and 3; and the HCV NS3 protease ...

New hepatitis C drug shows potential in phase 2 trials

October 10, 2013
The addition of danoprevir to the current treatment regimen for patients with hepatitis C leads to high rates of remission, according to a new article in Gastroenterology, the official journal of the American Gastroenterological ...

US panel backs Gilead Sciences' hepatitis C drug (Update)

October 23, 2013
U.S. Food and Drug Administration advisers on Friday unanimously voted in favor of a highly anticipated hepatitis C drug from Gilead Sciences that holds promise for millions infected with the liver-destroying virus.

Combination of oral drugs suppresses common type of hepatitis C

January 19, 2012
A new combination of investigational drugs successfully suppressed hepatitis C genotype 1 infection in a high percent of patients who had not responded to previous treatment in a study led by a University of Michigan hepatologist.

Recommended for you

Past encounters with the flu shape vaccine response

February 20, 2018
New research on why the influenza vaccine was only modestly effective in recent years shows that immune history with the flu influences a person's response to the vaccine.

Building better tiny kidneys to test drugs and help people avoid dialysis

February 16, 2018
A free online kidney atlas built by USC researchers empowers stem cell scientists everywhere to generate more human-like tiny kidneys for testing new drugs and creating renal replacement therapies.

Expanding Hepatitis C testing to all adults is cost-effective and improves outcomes

February 16, 2018
According to a new study, screening all adults for hepatitis C (HCV) is a cost-effective way to improve clinical outcomes of HCV and identify more infected people compared to current recommendations. Using a simulation model, ...

Study suggests expanded range for emerging tick-borne disease

February 16, 2018
Human cases of Borrelia miyamotoi, a tick-borne infection with some similarities to Lyme disease, were discovered in the eastern United States less than a decade ago. Now new research led by the Yale School of Public Health ...

IFN-mediated immunity to influenza A virus infection influenced by RIPK3 protein

February 15, 2018
Each year, influenza kills half a million people globally with the elderly and very young most often the victims. In fact, the Centers for Disease Control and Prevention reported 37 children have died in the United States ...

Flu shot only 36 percent effective, making bad year worse (Update)

February 15, 2018
The flu vaccine is doing a poor job protecting older Americans and others against the bug that's causing most illnesses.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.