While the $84,000 price of Gilead Sciences Inc.’s Sovaldi has riled lawmakers and public health advocates, doctors say this new generation of hepatitis C drugs may actually help cut costs.
In studies presented at the International Liver Congress in London this weekend, drugmakers including Gilead, AbbVie Inc., Merck & Co. and Bristol-Myers Squibb Co. showed that their latest medicines can achieve sustained cure rates approaching 100 percent, rendering obsolete an older generation of products with daunting side effects. That will mean shorter treatment, and fewer follow-up medicines and hospital visits, doctors said.
“These treatments have a high degree of tolerability and effectiveness, and the follow-up care and monitoring they require is almost nothing,” said Greg Everson, a professor of medicine at the University of Colorado who helped conduct trials for Gilead, Bristol-Myers and AbbVie, among others. “The cost per cure will come down.”
Hepatitis C, an infectious disease that can scar the liver and afflicts about 150 million people worldwide, is transmitted via blood, most commonly among drug users who share contaminated needles. Recently approved drugs to fight the virus, and many medications that are close to market, are effective with 12 weeks of treatment or possibly less.
Older approaches required injections of two medicines, the immune-system booster interferon and the antiviral ribavirin, for as long as a year, causing side effects including flu-like symptoms and anemia. Combined with Vertex Pharmaceuticals Inc.’s Incivek, those treatments cost almost $200,000 per cure, Everson said in an interview, citing research at New York’s Mount Sinai Hospital. Anemia in turn can require more drugs such as epoetin and GCS-F or even blood transfusions.
While earlier studies established that interferon can be avoided in the new regimens, studies presented at the liver meeting show that ribavirin may now also be unnecessary, especially for the most common strain of the virus. Merck’s “C-Worthy” study showed that its combination therapy can yield cure rates higher than 90 percent with or without ribavirin in both new patients and those who failed earlier treatment. Similar cure rates were found in a study of patients who took Gilead’s Sovaldi-ledipasvir combination, with or without ribavirin.
The effectiveness of the experimental drugs also suggests that treatment duration may go even shorter than 12 weeks. In a study that only enrolled patients with deadly liver cirrhosis, a particularly difficult treatment population, AbbVie showed that its triple combination cured 92 percent after 12 weeks and 96 percent after 24 weeks. The majority of patients had undetectable levels of the virus by the second week of the study, said Fred Poordad, the study’s lead investigator.
“We expect a competitive situation in cirrhotic patients, a key population due its size -- 25 percent of U.S. patients -- and unmet need,” Jeffrey Holford and colleagues at Jefferies LLC wrote in a note to clients today. AbbVie “presented impressive data.”
More studies are needed to ensure patients don’t relapse after ending treatment, according to Poordad, vice president of academic and clinical affairs at the Texas Liver Institute in San Antonio.
AbbVie would prefer overtreating to be safe, Scott Brun, the company’s head of research and development, said in an interview at the conference. “We don’t want to sacrifice rates of cure for convenience.”
Gilead also presented results this weekend from a mid-stage study for a new combination of Sovaldi with its experimental medicine GS-5816, which showed cure rates of more than 90 percent across all six genotypes -- or subtypes -- of the hepatitis C virus.
Another experimental combination, of the Merck drugs MK-5172 and MK-8742, also has potential as a so-called pan-genotypic treatment, according to Eliav Barr, vice president of infectious disease for the Whitehouse Station, New Jersey-based drugmaker. AbbVie is also in mid-stage testing of combining its ABT-493 and ABT-530 products across genotypes, Brun said.
Those treatments have the potential to simplify prescribing practice and eventually take hepatitis C out of speciality care and into primary care, according to Jordan Feld, assistant professor of medicine at the Toronto Western Hospital Liver Clinic.
“If you only treat 10 hepatitis C patients a year, you don’t want to have to be slicing and dicing; it’s much easier if it’s just one combination for everyone,” Feld said in an interview.
A pan-genotypic option would also be useful in remote areas or in developing countries with a dearth of diagnostic resources, said Graham Cooke, clinical senior lecturer in infectious diseases at Imperial College London.
“Models of care will get simpler,” Cooke said. “It’s a whole new world.”
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