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

Largest oral HPV study in England shows infection rates lower than expected

August 20, 2018
Infection rates of high risk human papillomavirus (HR-HPV) oral infection in England are lower than expected, compared to previous US studies.

Tibetan sheep highly susceptible to human plague, originates from marmots

August 16, 2018
In the Qinghai-Tibet plateau, one of the region's highest risk areas for human plague, Himalayan marmots are the primary carriers of the infectious bacterium Y. pestis. Y. pestis infection can be transmitted to humans and ...

Autoimmunity plays role in development of COPD, study finds

August 16, 2018
Autoimmunity plays a role in the development of chronic obstructive pulmonary disease (COPD), according to a study led by Georgia State University and Vanderbilt University Medical Center that analyzed human genome information ...

Reliable point-of-care blood test can help prevent toxoplasmosis

August 16, 2018
A recent study, performed in Chicago and Rabat, Morocco, found that a novel finger-prick test for infection with the parasite Toxoplasma gondii during pregnancy—and many other potential applications—is 100 percent sensitive ...

Scientists identify nearly 200 potential tuberculosis drug targets

August 16, 2018
Tuberculosis is one of the top 10 causes of death worldwide. Nearly 2 million people die every year from this infectious disease, and an estimated 2 billion people are chronically infected. The only vaccine, developed almost ...

First mouse model to mimic lung disease could speed discovery of more effective treatments

August 16, 2018
The biggest hurdle to finding effective therapies for idiopathic pulmonary fibrosis (IPF) – a life-threatening condition in which the lungs become scarred and breathing is increasingly difficult – has been the inability ...

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.