Published in the May 17 Annals of Internal Medicine, the study may help physicians worldwide in making treatment decisions. Researchers note that a degree of uncertainly exists on how to best initiate hepatitis B treatment due to a constant influx of newer, more expensive drugs that all have varying risks and benefits.
"We need to develop a more calculated approach and establish guidelines for the most cost-effective treatment," said Dr. Fasiha Kanwal, first author and research fellow, Division of Digestive Diseases, David Geffen School of Medicine at UCLA and Veterans Affairs Greater Los Angeles Healthcare System.
Researchers performed an economic analysis comparing the cost-effectiveness of five competing drug treatment strategies for chronic hepatitis B: 1) No treatment at all 2) Interferon alone 3) Lamivudine alone 4) Adefovir alone 5) Beginning therapy with lamivudine, but changing to adefovir if viral resistance is encountered.
Investigators found that the newest drug therapy -- adefovir ?was not cost-effective when taken alone. However, adefovir was very cost-effective when reserved as a second-line agent in people who develop viral resistance for lamivudine ?a therapy that has been available for over 15 years.
The study notes that interferon ?the oldest of all available therapies -- may still be preferred in health care systems with limited resources and is especially cost-effective with "e-antigen negative" patients, which is a more serious type of hepatitis B.
"We found that the newer, more 'sexy' drugs are too expensive and better to use only after other first line therapies have failed," said Dr. Brennan M. R. Spiegel, study author and co-director, Center for the Study of Digestive Healthcare Quality and Outcomes and assistant professor of medicine, David Geffen School of Medicine at UCLA and VA Greater Los Angeles Healthcare System. "The combined treatment strategy of lamivudine and adefovir is also a very viable option. This is part of a trend that we're seeing in other areas of medicine as well ?to use "hybrid" treatments that reserve expensive yet effective drugs for specific patients who have shown no success with other treatments."
Spiegel notes that the general cost-effectiveness standard accepted by society and many insurers for treating a chronic condition like hepatitis B is roughly $50,000 or less per quality-adjusted life-year gained, which is a standard measure used in assessing the outcome of health care procedures or services.
According to Kanwal, the study showed that only two strategies fell well within this accepted standard: Interferon cost an incremental $6,337 to gain an additional quality-adjusted life-year, compared to receiving no treatment at all. Compared with interferon, the hybrid strategy of lamivudine and adefovir cost an incremental $8,446 per quality-adjusted life-year.
In comparison, treatment with adefovir alone cost over $90,000 for each quality-adjusted life-year gained for patients with the e-antigen negative hepatitis B and would not be considered cost-effective according to researchers.
The comprehensive economic model adjusted for various patient scenarios including viral resistance, development of cirrhosis and other factors affecting treatment. Health costs included physician visits, diagnostic tests and complications of chronic liver disease.
Investigators based the model on average 40-year old patients with the most common type of chronic hepatitis B -- with elevated liver enzymes but no liver cirrhosis. Investigators also took into consideration the two types of hepatitis B -- either e- antigen positive or e-antigen negative -- which require different treatment approaches.
Hepatitis B is the most common serious liver infection in the world. The virus attacks liver cells and chronic hepatitis B disease can lead to liver failure, cirrhosis or cancer of the liver. About 90 percent of healthy adults who are infected with Hepatitis B recover with no problems, but 10 percent develop chronic disease. In children who have been infected, 60 percent develop chronic disease.
Other authors include Dr. Ian M. Gralnek, MSHS, Dr. Gareth S. Dulai, MSHS, and Mary Farid, Division of Gastroenterology, VA Greater Los Angeles HealthCare System and Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Center for the Study of Digestive Healthcare Quality and Outcomes, Los Angeles, California; and Dr. Paul Martin, Mount Sinai School of Medicine, New York, New York.