For the past year or so, many people diagnosed with the potentially deadly hepatitis C virus have been playing a waiting game—hoping that promising new treatments would become available before their livers suffered irreparable damage.
Now the wait is ending, at least for some patients, thanks to the recent approval of a breakthrough drug.
Why does this matter so much? Because more than 3.2 million Americans, mostly in the baby boomer generation, have hepatitis C—and the majority of them do not even know it. Here’s what you need to know about this deadly disease and the exciting new advances in its treatment…
In many patients, chronic hepatitis C infection is present for several decades before it is detected, either through a screening blood test or because liver damage develops. Symptoms of liver damage include fatigue, joint pain, jaundice, nausea and abdominal pain. Cirrhosis (scarring of the liver), liver cancer or liver failure eventually develops in about 30% of cases of chronic hepatitis C. However, the other 70% of patients never develop any significant liver damage—so when patients show no clear signs of advancing disease, doctors have often recommended a wait-and-see approach rather than jumping into treatment.
That’s because, until now, the standard treatment for hepatitis C involved a grueling 48-week regimen. Patients had to take as many as 18 pills every day—typically ribavirin plus boceprevir or telaprevir (both FDA-approved in 2011) or the newer simeprevir (approved in November 2013)—and also get weekly injections of interferon, which can cause horrid side effects such as extreme fatigue, muscle aches, rashes, flulike symptoms, gastrointestinal problems, anemia, anxiety and depression. These regimens are painful, expensive and fail to cure more than three in 10 patients.
There is no way to accurately predict who will suffer life-threatening complications from the infection and who will remain symptom-free. So once doctors learned about new drugs on the verge of winning FDA approval, many stopped recommending treatment with the older hepatitis C drugs for patients who were not in imminent danger, said Sammy Saab, MD, head of Outcomes Research in Hepatology at the Pfleger Liver Institute at University of California, Los Angeles.
Game changer: In December 2013, the FDA approved the new one-dose-daily oral drug sofosbuvir (Sovaldi), which works by inhibiting a particular enzyme that the hepatitis C virus uses to replicate. The FDA even awarded the drug a “breakthrough therapy” designation, reserved for therapies that represent substantial improvement over previously available therapies for treating serious or life-threatening diseases.
Though it’s not perfect, sofosbuvir offers significant advantages over the earlier treatment options. For one thing, many (though not all) hepatitis C patients being treated with sofosbuvir do not need to get interferon injections at all…and those who do also need the injections are cured four times more quickly than patients using the older drugs along with interferon. Also, the overall cure rate is substantially higher with sofosbuvir, topping 90%, compared with about 65% to 70% for the older drugs—and studies showed that patients who did not respond to the older drugs were among those who benefited from sofosbuvir.
In clinical trials, sofosbuvir caused only mild side effects, such as slight fatigue and headache. Of course, as with any new medication, only time will tell whether the drug has additional risks or side effects.
All in all, Dr. Saab said, sofosbuvir will make it easier and more logical to treat hepatitis C without waiting to see whether liver damage will develop.
There are six different strains, or genotypes, of hepatitis C. Treatment with sofosbuvir varies depending on the genotype…
Genotype 2 and genotype 3 account for about 20% to 25% of hepatitis C cases in the US. These patients can take sofosbuvir along with ribavirin without the need for also getting interferon injections. Genotype 2 treatment takes about 12 weeks…genotype 3 treatment takes about 24 weeks.
Genotype 1 accounts for more than 70% of cases in the US. When these patients take sofosbuvir, they also must take ribavirin and get interferon injections—but the course of treatment is much shorter than with the old drugs. Previously, patients needed the weekly interferon injections for nearly a year, but with sofosbuvir the disease can be cured in just 12 weeks.
The other three genotypes are rare in the US. Dr. Saab said, “Sofosbuvir is FDA-approved for treating genotype 4. It is not approved for genotypes 5 and 6—there were few such patients in the clinical trials—however, hepatologists will likely use sofosbuvir-based therapy off-label because, despite the small numbers of such patients [in the studies], the efficacy rates appeared to be very high.” For these genotypes (as with genotype 1), sofosbuvir-based therapy involves a relatively short course of treatment that also includes ribavirin and interferon.
The biggest problem with sofosbuvir may be the expense—the drug costs about $80,000 to $90,000 for a course of treatment. Dr. Saab noted that this is similar to the full cost of the longer course of treatment needed with the older drugs. Advocacy groups are gearing up to fight for full insurance coverage—but for now, patients have to check with their own insurance companies to see where things stand. Gilead Sciences, the pharmaceutical company behind sofosbuvir, has set up a program called Support Path to offer financial assistance to certain patients.
On the horizon: Dr. Saab said that he is excited about what’s still coming down the pike for hepatitis C patients. Within about another year, he anticipates that several other new drugs will be approved. The upcoming drugs are expected to cure hepatitis C in as little as eight weeks…in some cases, with just a one-pill-per day regimen…and with only minimal side effects.
If you have never been screened for hepatitis C: The Centers for Disease Control and Prevention recommends that everyone born between 1945 and 1965 get the hepatitis C blood test because 75% of infected Americans were born during those years—so talk with your doctor about being tested. Remember, most people who have hepatitis C do not realize it until symptoms of liver damage develop.
If you already have a hepatitis C diagnosis: See your doctor to check your liver function and discuss updating your individual treatment plan. For instance…
Bottom line: Hepatitis C is a dangerous disease…but the tools for fighting it are better than they’ve ever been.
