The direct-acting antiviral drugs have revolutionized the treatment of hepatitis C and even have some enthusiastic experts contemplating eradication of the disease.
Before Sovaldi (sofosbuvir), Harvoni (ledipasvir and sofosbuvir), and Viekira Pak (ombitasvir, paritaprevir, ritonavir, dasabuvir) came on the market in the early 2010s, interferon-based HCV therapies were inconvenient (interferon is injected), prolonged (48 weeks), and had less-than-stellar outcomes (40% of people infected with the most common genotype of the virus, genotype 1, were cured). By contrast, Sovaldi and the others in the new wave of antivirals are oral drugs and taken over a period of 12 weeks. The cure rates—usually defined as the sustained virologic response, which means undetectable levels of hepatitis C RNA 12 weeks after the end of therapy—are 90% or better. Concern that the direct-acting antivirals would be problematic or ineffective in various subgroups of hepatitis C patients (those who are also infected with HIV, those with liver or kidney problems) have faded as evidence from clinical trials showed that, by and large, they were just as effective in those circumstances.
|Approved treatment regimens for chronic hepatitis C virus infection|
|Direct-acting antiviral (DAA) approved as part of an antiviral combination||Brand name||FDA approval||SVR12 for treatment-naive HCV|
|Simeprevira||Olysio||2013||GT 1: 97%|
|Sofosbuvir+P/R||Sovaldi||2013||GT 1: 89%|
|Ledipasvir/sofosbuvir||Harvoni||2014||GT 1: 99%
GT 4: 94%
GT 5: 93%
GT 6: 96%
|Paritaprevir/r/ombitasvir+dasabuvir||Viekira Pak||2014||GT 1: 96%|
|Paritaprevir/r/ombitasvir+ribavirin||Technivie||2015||GT 4: 100%|
|Daclatasvira||Daklinza||2015||GT 1: 96%
GT 3: 90%
|Elbasvir/grazoprevir||Zepatier||2016||GT 1: 95%
GT 4: 97%
|Sofosbuvir/velpatasvir||Epclusa||2016||GT 1: 99%
GT 2: 100%
GT 3: 97%
GT 4: 100%
GT 5: 97%
GT 6: 100%
|GT=genotype, P/R=pegylated interferon/ribavirin, r=ritonavir boosting, SVR12=sustained virologic response 12 weeks after end of treatment.
aResponse rates provided are for the oral combination of the DAA+sofosbuvir as per the label
The dark cloud in this otherwise rosy picture has been the price tags affixed to these drugs, starting with the $1,000-per-pill price (which worked out to $84,000 per treatment) that Gilead put on Sovaldi.
A study published earlier this year by University of Pennsylvania researchers found that between January 2016 and April 2017, more than half of private insurers declined to pay for the medications. Medicaid turned down more than a third of requests while Medicare denied almost 15%. The Penn researchers found that insurers are more apt to OK the new hepatitis C drugs for members who abstain from alcohol and illegal drugs and for those with advanced liver fibrosis. Their findings were based on an analysis of more than 9,000 prescriptions for hepatitis C therapy submitted to Diplomat Pharmacy, a national specialty pharmacy.
“Insurers continue to deny coverage at alarmingly high rates, particularly in the private sector,” Vincent Lo Re III, an associate professor of infectious disease and epidemiology and senior author of the study, said in a statement. “It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions.”
Meanwhile, a number of states have lost lawsuits involving Medicaid beneficiaries while settlements have been reached in Florida, Pennsylvania, and Massachusetts. People who are incarcerated have also sued to get access to the expensive antivirals. An Indiana court ruled in September that withholding or delaying treatment for inmates with hepatitis C was unconstitutional. Lawsuits are pending or have been settled in other states.
The outrage and bad press, the legal action, and the increased competition have put some downward pressure on prices. For example, last year AbbVie launched Mavyret (glecaprevir and pibrentasvir) at a price of $26,400 for a round of treatment. In July, Merck said it was lowering the price of its hepatitis C drug Zepatier (elbasvir and grazoprevir) by 60%. The list price had been almost $55,000 for a course of treatment.
A few months later, Gilead announced it was launching authorized generic versions of its medications. The list price would be $24,000, and the generics are scheduled to be available in January.