Approval of Newer, More Effective Hepatitis C Drugs Means a Cure Is Within Reach for Most Patients

Within the next two years, treatments for hepatitis C with 95% cure rates that are all-oral, interferon free, and effective over 12 weeks or less with negligible side effects will be readily available, a national expert said Sunday at Digestive Disease Week 2014 in Chicago, IL.

It’s amazing to be talking about a cure for a virus that researchers discovered only in 1989, said Donald Jensen, MD, FACP, professor of medicine and director for the Center for Liver Disease at University of Chicago Medicine. But it’s important to use that term “cure,” he said.

“I think it is incumbent on us with our patients to use the word ‘cure.’ There’s certainly good data that patients remain virus-undetectable over time… Even cirrhosis has been shown to improve in many of these patients. I think we do a great disservice to our patients in the field if we don’t use the word ‘cure’.”

But until recently, that term wasn’t in HCV researchers’ vocabulary. In 2009, Jensen was part of a 15-member advisory board of key leaders in the field who predicted we would always need interferon to treat hepatitis C; the absolute shortest duration of therapy for genotype 1 would be 24 weeks; ribavirin would always be needed; and the maximum sustained virologic response (SVR) for genotype 1 would be 88%.

“How wrong we were,” Jensen said. And now he has new predictions:

• Pan-genotypic therapy will be available by the end of 2016, possibly with different treatment durations but perhaps a one-size-fits-all therapy
• Pre-treatment predictors such as viral load, genotype, age, and insulin resistance will lose their relevance. “I think we’re seeing that already,” he said.
• Special patient populations needing unique modifications will disappear. Patients who are co-infected with HIV, patients with liver transplants, and even those with decompensated liver disease are responding well to the new treatments, so making the distinctions among categories won’t be needed. “We’re not quite there yet, but I think that’s going to happen,” he said.

The progress comes in the sudden burst of drugs clinicians have available to use in fighting HCV. Combining drugs from different classes has led to increased efficacy and diminished viral resistance.

In late 2013, the Food and Drug Administration approved two drugs‑‑simeprevir (a protease inhibitor used in combination with pegylated interferon plus ribavirin) and sofosbuvir (a nucleotide polymerase inhibitor)‑‑which paved the way for interferon-free treatment.

Treatment with these drugs could be shortened to 12 weeks instead of 24, which meant multiple combinations could be tested in the same time it used to take for one.

And patients are tolerating them “incredibly well,” Jensen said.

However, the costs associated with the new treatments are undeniably formidable. Sofosbuvir costs $84,000 for a 12-week course, while Simeprevir costs more than $66,000 for a 12- week course. Many payers have been reluctant to cover these medications, and Jensen said he doesn’t predict costs will come down substantially anytime soon.

The high cost of these drugs also puts increased pressure on treatment adherence. “With sofosbuvir being $1,000 a pill, I tell my patients … if the dog licks it, you take it,” Jensen said.

Simplicity will be important if we want providers beyond hepatologists to use it, he said. Having simple therapy for hepatitis C that is not so algorithmic in terms of response-guided therapy will help the therapies gain wider acceptance and move forward.

The hope is that new therapies will uncover and help a much larger patient pool.

Fewer than half of the patients in the US who are infected with the hepatitis C virus know they have it. Having interferon-free therapies may encourage people to get tested and encourage many of those who know they have the virus but haven’t come forward because they’ve heard horror stories from interferon-based drug regimens to seek treatment.