SAN ANTONIO (Jan. 4, 2013) — A study published this week in the New England Journal of Medicine offers hope of an effective treatment for hepatitis C with fewer ill effects than interferon therapy, which has long been the standard of care.
Study authors include Fred Poordad, M.D., and Eric Lawitz, M.D., clinical professors of medicine in the School of Medicine of The University of Texas Health Science Center at San Antonio. Dr. Poordad is the study’s lead author.
The interferon-free treatment studied by Drs. Poordad and Lawitz showed especially promising results among hepatitis C patients who had received no previous treatment. Outcomes were mixed among patients who had been treated previously, but many still benefited.
“This study is a landmark in the advancement of hepatitis C treatment and marks the beginning of the end of interferon-based therapies,” Dr. Poordad said. “We have proven the concept that we can now cure hepatitis C with only 12 weeks of pills in a very well-tolerated regimen. There will be several of these all-oral direct-acting antiviral regimens on the market within a few years.”
More than 3 million Americans have hepatitis C, making it the most common blood-borne infection in the United States. The virus often goes undetected – sometimes for decades – due to lack of symptoms. Long-term infection is a leading cause of cirrhosis, liver cancer and liver transplantation.
Interferon therapy is the standard treatment for chronic hepatitis C infection. Interferon is a protein that fights hepatitis C in several ways: It protects healthy cells, boosts the immune system, and prevents the virus from multiplying. However, interferon therapy is associated with substantial toxicity and can only be given by subcutaneous injection. And when interferon therapy fails, few treatment options remain.
Seeking an interferon-free treatment, study authors examined two investigational drugs from Abbott Laboratories, which also funded the research. The Phase 2 study recruited several dozen patients, including some who had never received treatment for hepatitis C and others for whom prior treatment had failed. The study excluded patients with co-existing hepatitis B or HIV infection, or with cirrhosis or advanced liver fibrosis.
Study participants received treatment for 12 weeks and were evaluated for 48 weeks after receiving their first dose. Throughout the study, patients were regularly screened for the virus’ genetic material, HCV RNA, which is used to detect hepatitis C infection and monitor treatment effectiveness.
Participants were divided into three groups:
- Group 1 included 19 previously untreated patients, who were given the two investigational drugs, along with the antiviral ribavirin and antiretroviral ritonavir.
- Group 2 included 14 previously untreated patients, who were given the same four drugs but received lower doses of one investigational drug and ritonavir.
- Group 3 included 17 patients whose prior treatments had been unsuccessful. They were given the four drugs in the same dosages as Group 2.
In both groups of previously untreated patients, the results were dramatic. In those groups, 93 to 95 percent of patients had undetectable levels of HCV RNA 48 weeks after the onset of treatment and were considered cured of hepatitis C.
HCV RNA levels initially declined in all patients who had received prior treatment for hepatitis C, but several patients relapsed during or after treatment. At the final follow-up visit, eight of the original 17 (47 percent) patients had undetectable levels of HCV RNA. These “null responders” are considered the hardest to cure of all hepatitis C patients.
The investigational drugs caused no serious adverse effects during the study. The most common complaints during treatment were fatigue, nausea, vomiting, headache, dizziness, insomnia, pruritus and rash. Most of these episodes were mild.
Still needed are larger studies to confirm these results, as well as further investigation on the safety and efficacy of these drugs in patients with cirrhosis or co-existing HIV infection.
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