By Helen K. Kelley
From ATLANTA Medicine, Vol. 85, No. 4
Hepatitis C, the most common blood-borne infection in the United States today, is considered a public health threat. From new medications just entering the market and clinical trials to educational efforts and a push for identifying those who have the infection, hepatitis C is a hot topic among medical practitioners in Atlanta and elsewhere.
Baby Boomers at risk; new meds have unprecedented success
Hepatitis C is most prevalent in the Baby Boomer generation – those born between 1945 and 1965 – many of whom are asymptomatic and don’t yet know they have the infection. Roughly three-fourths of the current population is now aging and falling into the targeted bracket for having the infection, according to Lance Stein, M.D., a transplant hepatologist at Piedmont Transplant Institute.
“Age is important. If you are infected with hepatitis C, it can do significant damage to the liver … and it actually takes approximately 30 years for that to happen in most patients. So, let’s say if a person was infected in 1970 and is now turning 65, that’s when we’ll begin seeing the problems,” he explains. “Hepatitis C has become a big public health issue. This is why there’s been a huge increase in the establishment of liver cirrhosis clinics and transplant clinics.”
Stein adds that the uptick in patients identified as having hepatitis C just happens, fortunately, to coincide with helpful advances in medicine.
“Hepatitis C has been ‘blowing up’ in terms of new treatment options. These new drugs are much more effective than older treatments like Interferon and Ribavirin, both of which carry significant side effects. But the new treatments are also much more expensive,” he says.
According to Stein, sofosbuvir (Solvadi), which was approved by the FDA in December 2013, is priced at about $84,000 for a three-month treatment. That equates to roughly $1,000 per day. However, the drug has been highly successful to date, with an approximate 89 percent cure rate in people with hepatitis C type 1. Stein says that the high cost upfront may actually end up saving patients and insurers money in the long run.
“The higher cure rate of sofosbuvir, along with fewer side effects than previous treatments, means fewer doctor visits and lab tests than previously required on a regimen like Interferon. It may also prevent the need for a transplant in the future,” he notes. “Some even newer drugs are currently awaiting approval later this year. This is exciting because clinical trials show cure rates for these new treatments are almost 100 percent after a three-month regimen.”
Aasim M. Sheikh, M.D., who specializes in the treatment and management of liver diseases as a gastroenterologist, hepatologist and clinical researcher with GI Specialists of Georgia, agrees that the new drugs hold great promise for people infected with hepatitis C.
“The envelope is being pushed,” he says. “Researchers – big players like Merck, Gilead, Johnson and Abbott – are looking for regimens that combine drugs to result in a minimum number of pills with the fewest side effects and shortest treatment.”
Sheikh adds that there are four different classifications of drugs that are proving to work well in combination.
“These drugs block the hepatitis C virus at different points, shutting down different enzymes that help the virus multiply,” he explains. “Together, they have a synergistic effect in controlling the virus.”
Sheikh states that the most important keys to treating and curing hepatitis C are: identifying people who have the infection; prioritizing and treating those who have the most advanced disease; the development of more effective treatments of shorter duration and fewer side effects; and analyzing the results of various treatment protocols.
“The more people we treat, the more we find out,” he says. “We hope to alter the course of their illness and keep them at a lower risk for further complications.”
Enrique Martinez, M.D., a gastroenterologist and hepatology specialist with Atlanta Gastroenterology Associates, has watched the progression of hepatitis C treatments since he began practicing in 1989.
“This is a very exciting time. It’s amazing when you consider that a disease with only an 8 percent cure rate 25 years ago is now approaching a 100 percent cure rate,” he says. “And it’s interesting that today we consider treatments with a less than 95 percent cure rate to be inferior. Pharmaceutical companies are constantly looking at new combinations of drugs that could result in better and better cure rates for hepatitis C patients.”
Martinez adds that the evolution of drug combinations also holds great promise for special populations with hepatitis C.
“People we previously thought could not be treated for hepatitis C are now being considered possible candidates for the new drug regimens,” he says. “These populations include people with immune disorders such as lupus and rheumatoid arthritis, sickle cell disease or colitis. Even people who must undergo dialysis or who are pre- or post-transplant patients have new hope for treatment.”
Providing care to an underserved population
The Grady Liver Clinic at Grady Memorial Hospital, established in 2002, is an innovative model for expanding access to hepatitis C care for urban, underserved patients. This population is disproportionately affected by the infection. Dr. Lesley Miller, the clinic’s medical director, says the facility is a unique and revolutionary model because it is run and staffed by general internists (rather than specialists), who work together to provide hepatitis C management – including antiviral treatment – to patients regardless of their insurance status.
“Patients without options for specialty care really benefit from this clinic,” Miller says. “We do a lot of education and counseling, and we provide immunizations against hepatitis A and B, evaluation of liver disease and medical comorbidities, and treatment options. We’re one of the only places [in Atlanta] that can offer these services to people who don’t have health insurance.”
A study of the Liver Clinic’s population for its first five years of operation showed that it was primarily African American (76 percent) and uninsured (59 percent). Patients had difficult-to-treat characteristics, including genotype 1 hepatitis C (90 percent), advanced liver fibrosis (28 percent), and high viral loads. Sixty-seven percent had comorbid medical conditions, and 40 percent had psychiatric disease. Fourteen percent of patients were treated for hepatitis C during the study period.
With those early statistics in mind, Miller is pleased with the medical advances that have made hepatitis C treatment easier for the Clinic’s current patients and is excited about the speed at which new treatment options are progressing.
“It’s unbelievable how fast the research and development in the world of hepatitis C are changing. Things I was doing last month are already different,” she says. “More of our patients are now candidates for treatment than have been in the past, because treatment duration is shorter and the regimens are easier or more relevant for people who have other chronic health problems. It’s gratifying to give patients a regimen that’s not going to make them sick and has a high probability of curing them.”
The stats on hepatitis C
In the National Health and Nutrition Examination Survey (NHANES), conducted between 2003 to 2010, researchers studied people with hepatitis C in order to estimate the prevalence of chronic HCV infection and to identify factors associated with the condition. The survey included interviews and testing of serum samples from participants aged six years and older.
Based on 273 participants who tested positive for HCV RNA:
• The estimated prevalence of HCV infection was 1.0 percent (95 percent CI, 0.8 percent to 1.2 percent), corresponding to 2.7 million chronically infected persons (CI, 2.2 to 3.2 million persons) in the U.S. non-institutionalized civilian population.
• Infected persons were more likely to be aged 40 to 59 years, male, and non-Hispanic black and to have less education and lower family income.
• Factors significantly associated with chronic HCV infection were illicit drug use (including injection drugs) and receipt of a blood transfusion before 1992; 49 percent of persons with HCV infection did not report either risk factor.
Based on the data collected, researchers estimated that approximately 2.7 million U.S. residents in the population sampled by NHANES have chronic HCV infection. The study highlighted the continued urgency of identifying the millions of persons who remain infected and linking them to appropriate care and treatment.
In the news
According to a recent article in The New York Times, “sales of the new hepatitis C drug Sovaldi reached $3.5 billion in the second quarter, a huge figure that puts it on track to become one of the world’s best-selling medicines but could intensify concerns about society’s ability to pay for it.”
The FDA-approved drug, manufactured by Gilead Sciences, is for patients with hepatitis C virus (HCV) genotypes 1, 2, 3 or 4 infection.