New drug combination eliminates need for complex regimens
By Maggie Van Dyke
The prognosis for people with hepatitis C has improved dramatically in the last few years, thanks to the introduction of direct-acting anti-viral medications, including Harvoni (the brand name for a combination of ledipasvir and sofosbuvir) and Viekira Pack (a mix of ombitasvir, paritaprevir, ritonavir and dasabuvir). These drugs — which block the hepatitis C virus from multiplying — boast cure rates of better than 90 percent. In addition, they are well-tolerated in most patients, causing only minor side effects.
Despite these major advances, the quest for better hepatitis C medications is not yet over. Drug makers continue to test new drugs to overcome limitations in treating this virus, which can cause liver cirrhosis (or scarring) and failure. About 2.7 million people in the U.S. are infected with the virus, with nearly 30,000 cases occurring in 2013 alone, according to the Centers for Disease Control and Prevention.
“The current medicines are very effective, but physicians sometimes have to tailor the regimen or the length of treatment based on patient characteristics, such as whether the patient has liver cirrhosis or has failed prior therapy,” says Nancy S. Reau, MD, chief of the Section of Hepatology at Rush University Medical Center.
Another treatment factor is the type of hepatitis C a patient has. The virus has six different strains, called genotypes.
Now a simplified way of treating all hepatitis C patients may be approaching. Reau participated in a phase III clinical trial of a combination of Solvadi (sofosbuvir) with the investigational drug velpatasvir on patients with genotypes two and three. As described in an article published online on Nov. 17 in the New England Journal of Medicine, the study found that 12 weeks of sofosbuvir-velpatasvir produced higher cure rates in patients with these two genotypes — including those who had cirrhosis or had failed older treatments — than a similar therapy (sofosbuvir-ribavirin).
Additional trials of sofosbuvir-velpatasvir published in the same issue of the journal, show that the drug is equally effective in treating other hepatitis C genotypes. “This combination is the closest we now have to a one-size-fits-all regimen for hepatitis C,” Reau says.
Fewer rules to follow
The once-daily sofosbuvir-velpatasvir pill aims to simplify treatment for the majority of hepatitis C physicians and their patients. “It is going to be a very easy-to-apply regimen that works on most hepatitis C patients and doesn’t have a lot of complicated rules to follow,” Reau says.
The drug’s manufacturer, Gilead Sciences, also is claiming that the drug may eliminate the need for genotype testing in hepatitis C patients. (Reau consults with and performs research for various pharmaceutical companies, including Gilead, on hepatitis C drugs.)
Reau cautions, however, that there always will be some hepatitis C patients who require more specialized treatment. “Specialists will still be challenged by patients who have significant comorbidities or advanced liver disease and by patients who have failed the newer treatment regimens,” she says. “A one-size-fits-all approach would not be appropriate in these cases. But that’s a minority of patients.”
Easier, but not necessarily affordable
The new drug, sofosbuvir-velpatasvir, has not yet been approved by the U.S. Food and Drug Administration. The FDA has assigned the drug a Breakthrough Therapy Designation, which means the agency will expedite its review.
Assuming the FDA approves sofosbuvir-velpatasvir, the next hurdle will be insurance coverage. Similar hepatitis C drugs are very expensive. For instance, Harvoni costs around $94,000 for a 12-week course, according to various news reports.
To help cover the costs, some payers and/or pharmacy benefit managers have negotiated steep discounts with drug companies in exchange for preferred drug status on their formularies. “The ability to use this drug will depend on whether a payer picks this regimen over another regimen,” Reau observes.
She stresses that all the direct-acting anti-viral drugs for hepatitis C work well and are well tolerated. “I see sofosbuvir-velpatasvir as being a really good option. It’s an easier-to-apply regimen. But that doesn’t mean it is significantly better than similar drugs.”