An experimental trial of two drugs in one pill had a high cure rate for patients infected with hepatitis C.
A new drug combination has effectively cured hepatitis C in 97 of the first 100 people, according to clinical trial results published today in The Lancet. Compared with hep C medications that are available for patients now, the experimental drug combination of sofosbuvir with ledipasvir worked faster to eliminate the virus — and had fewer side effects. The drug was also effective for patients with hepatitis C who already had advanced liver disease, called cirrhosis.
Eric Lawitz, MD, the lead investigator of the sofosbuvir and ledipasvir trial published today, said, “We tested these medicines among HCV patients with genotype 1 HCV infection — the most difficult strain of the virus to treat. Some of these patients had cirrhosis of the liver, or had failed prior therapy with protease inhibitors, and are considered among the most challenging patients to cure of HCV.”
The results of the new drug study are important because many of the 3.2 million people in the United States who are infected with hepatitis C can’t take currently available hepatitis treatments due to serious side effects including depression and anemia. In addition, certain strains of the hep C virus are resistant to treatment, and in many patients with hep C who complete current treatment regimens, the drugs fail to clear the virus. For these patients, no FDA-approved treatment options remain.
A New Approach to Hepatitis C
More people are living with — and dying from — hepatitis C than with HIV in the United States today. The experimental antiviral drugs included in this study, sofosbuvir with ledipasvir, are two of a group of new medications aimed at overcoming the limitations of current therapy and reaching more patients with hep C.
These new drugs, which are direct-acting antiviral (DAA) medications, target the hepatitis C virus directly and include faldaprevir, sofosbuvir, ledipasvir, simeprevir, daclatasvir and asunaprevir.
The promising study results showed that the amount of hepatitis C virus in patients’ blood samples dropped sharply after only one week of treatment with the combo drug. By two weeks, 90 percent of the patients treated had undetectable levels of virus remaining. And by the fourth week, this reached 99 percent of patients. Researchers followed the patients for 12 weeks of treatment, and for a six month follow-up period. By the end of the six months, 97 percent of the patients taking the new drug had eliminated hep C virus from their blood.
“This means they are considered cured of HCV,” said Dr. Lawitz.
Overcoming Side Effects of Hep C Drugs
Researchers classified the side effects of the new drug combination as mild, including nausea, upper respiratory tract infection, and headache. Some of the patients, who took the new medication in combination with another antiviral, ribavirin, experienced anemia — a side effect of ribavirin.
Lucinda Porter, RN, a nurse who was diagnosed with hep C in 1988 and took part in the trial as a patient, said, “Anemia is probably the most difficult side effect of ribavirin. Anemia causes fatigue and other issues, such as dizziness and shortness of breath.”
In prior hep C drug treatments, ribavirin was usually given in combination with injections of interferon, a drug which boosts the body’s immune response to hep C. “Interferon has many side effects, but the hardest to handle are depression and inability to concentrate,” Porter said.
She reported these clear benefits of the new treatment for her:
- Much safer with fewer side effects
- Only 12 weeks of treatment verses up to 48 weeks, which means the duration of side effects will be briefer
- Very high cure rates
Higher Hep C Cure Rates in the Future
“This regimen and other interferon-free combination direct-antiviral agents combining polymerase inhibitors with second generation protease inhibitors or NS5A inhibitors are revolutionary,” said Alexander Kuo, MD, who was not involved in the research. Dr. Kuo is a liver expert and Director of Hepatology and Medical Director of Liver Transplantation at the University of California, San Diego Health System.
“The bar has now been raised with expectations being for new regimens to be interferon-free, all oral, well tolerated, with cure rates of 95 to 100 percent with 12 weeks or less of therapy,” said Kuo.
Patients newly diagnosed with hep C may benefit from the new drug when it becomes available later this year. In addition, Kuo said, “These new treatments offer hope to a larger number of patients who have previously failed interferon-based therapy, OR are intolerant of or have contraindications for interferon, such as patients with advanced cirrhosis or those with severe psychiatric disease.”
Professor Margaret Hellard MD, of the Centre for Population Health at the Burnet Institute in Melbourne, Australia, put the research findings in perspective. “The study was a Phase 2 study: Whilst impressive it is important to wait for the results of further trials.”
She added, “The vast majority of people could be cured of their hepatitis C — the issues will then become one of access and cost.”
Dr. Hellard wrote an op-ed article accompanying the research report in JAMA Internal Medicine; she was not involved with the research study. She sees the potential for population level benefit from the new treatments. “Models suggest that increased treatment uptake with highly efficacious DAAs, combined with harm reduction interventions — like needle and syringe programs and opiate substitution therapy — can substantially reduce hepatitis C prevalence.” In other words, needle exchange programs for people addicted to intravenous drugs can also help lower hepatitis C rates; the majority of new cases of hep C are the result of IV drug use.
An U.S. FDA advisory panel recommended approval of two new drugs — sofosbuvir and the hep C drug simeprevir — for the treatment of hep C. Approval of sofosbuvir for hep C will be decided by the FDA after further Phase 3 trial results are considered, according to study investigator Lawitz.
Reposted from Everyday Health on January 10, 2015: www.everydayhealth.com/hepatitis/drug-combo-cures-high-percent-of-hep-c-patients-6209.aspx
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