(dailyRx News) Hepatitis C is an infection that can lead to serious liver problems. As such, treatment is required to protect patients from these complications. Unfortunately, one treatment does not appear to do much good.
Interferon monotherapy, or treatment with interferon medication alone, is not the first line of defense against hepatitis C. However, it is used in some patients who cannot be treated with other medications.
A recent review of past studies found that patients with hepatitis C and liver disease who had poor responses to initial treatment did not do much better when retreated with interferon. Some of these patients were even more likely to die earlier and to experience serious side effects.
In light of these poor outcomes, in addition to the extremely high costs of interferon treatment, the authors could not recommend interferon retreatment to hepatitis C patients who did not respond to their first interferon treatment.
The review was led by Ronald L. Koretz, MD, of Granada Hills, California.
About 170 million people around the world are affected by hepatitis C. In some patients, hepatitis C infection leads to chronic liver disease, liver failure or liver cancer - all of which can result in death.
Interferon treatment of hepatitis C costs thousands of dollars per year to treat just one patient. However, there is still little evidence that retreatment with interferon alone works. Treatment is considered successful if a patient's blood shows no evidence of the hepatitis C virus six months after treatment - a result known as sustained viral response (SVR). Research has yet to show that SVR actually improves patients' disease state or chances of survival.
For their review, Dr. Koretz and colleagues looked at seven studies involving a total of 1,976 patients with chronic hepatitis C. These patients were being retreated with interferon monotherapy after previous interferon treatment failed.
When the researchers included all the past studies in their analysis, results showed that patients retreated with interferon had a similar risk of death as those treated with placebo (fake medication) or who received no treatment.
The researchers did a second analysis in which they excluded studies with possible bias and less reliable methods, leaving two large studies that included 1,676 patients. In this analysis, patients retreated with interferon had a higher risk of death than those who received placebo or no treatment (9.4 percent vs. 6.7 percent, respectively).
Results also showed that negative side effects were more common in patients receiving interferon. The most common side effects were blood-related complications, infections, flu-like symptoms and rash.
One benefit of interferon treatment was that it appeared to reduce the rate of nonfatal internal bleeding. Internal bleeding was seen in four of 843 (0.5 percent) of interferon patients. In comparison, 18 of 867 (2.1 percent) of placebo or non-treatment patients experienced internal bleeding.
"It was troubling to see that in those trials providing the most reliable estimates of treatment effects, interferon seemed to increase the risk of death," said Dr. Koretz. "Based on these results, interferon monotherapy cannot be recommended for chronic hepatitis C patients who have already failed one course of treatment and are being retreated. Furthermore, patients who are receiving interferon as part of a combination therapy should be informed about this potential adverse effect."
While the review showed that interferon treatment reduced levels of hepatitis C (as shown by SVR), the treatment was still not associated with improvement in disease or a lower risk of death. This finding suggests that SVR may not be a good measure of treatment success.
"Sustained viral response did not suggest that a patient who was destined to develop symptoms or death from hepatitis C was cured, at least in this setting. This tells us that as a treatment outcome it is not universally reliable and needs to be validated before it can be viewed as the goal of any therapy in other clinical scenarios," said Dr. Koretz.
The review was published January 31 in The Cochrane Library. No funding or disclosure information was available.