Hepatitis C- AbbVie to Present Late-breaker PEARL-III Study at the 21st Conference on Retroviruses and Opportunistic Infections
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New Interferon-Free Drugs for Hep C Show High Cure Rates
BOSTON — A revolution is happening in the treatment of hepatitis C virus, with new interferon-free drugs bringing cure rates of more than 90%.
Results from several trials were presented on opening day here at the 2014 Conference on Retroviruses and Opportunistic Infections.
In the PEARL-III trial, treatment-naïve noncirrhotic adults with chronic genotype 1b (GT1b) hepatitis C were treated with an investigational all-oral interferon-free treatment from AbbVie plus ribavirin. After 12 weeks of treatment, sustained virologic response rates reached 99.5%. Even in difficult-to-treat cirrhotic patients, response rates reached 92% to 96%.
"Therapies currently being developed for the treatment of hepatitis C offer patients new options with shorter durations of treatment," said Javier Boix, a spokesperson for AbbVie.
This investigational regimen is appropriate for broad use in all genotype 1 patient populations, and in subgroups with GT1a or GT1b disease, in both treatment-naïve and treatment-experienced patients, Boix told Medscape Medical News. It's also appropriate for "those who typically do not respond well to treatment, such as previous nonresponders to interferon-based therapy and patients with advanced liver fibrosis or cirrhosis," he added.
This National Institutes of Health (NIH) SYNERGY study looked at 3 different regimens of interferon-free therapy in a difficult-to-treat hepatitis C patient population, 88% of whom were black. After 6 and 12 weeks of treatment, sustained virologic response rates reached 95% to 100%.
"One of the things we learned from this trial is that we can treat people with short durations of therapy," said Anita Kohli, MD, from the NIH in Bethesda, Maryland. "Also, these regimens are very simple. They are 1, 2, or 3 pills once a day," she explained.
The phase 3 PHOTON-1 study is the first study of an interferon-free agent in the treatment of patients coinfected with HIV and hepatitis C. After 24 weeks of the once-a-day nucleotide analog polymerase inhibitor sofosbuvir ( Sovaldi), from Gilead, overall sustained virologic response was 76% in patients with genotype 1 hepatitis C, 88% in those with genotype 2 disease, and 90% in those with genotype 3 disease.
In December 2013, the US Food and Drug Administration approved sofosbuvir for the treatment of chronic hepatitis C infection.
Reaching Those in Need
The development of hepatitis C drugs "in the past few years is unprecedented," said Lynn Taylor, MD, from the division of infectious diseases at Miriam Hospital, Brown Medical School, in Providence, Rhode Island.
In the United States, the next step is to build the infrastructure to get the new drugs to the people who need them, she told Medscape Medical News. This will include building up a workforce of people who treat hepatitis C and providing financial incentives and reimbursement reforms.
"Medicare and Medicaid are going to have to pick up the tab for these drugs," because hepatitis C most often occurs in low-income populations. "It's going to be a crisis," she said. "But it will also force people into a rational, deliberate, thoughtful discussion about what we are going to do about hepatitis C."
2014 Conference on Retroviruses and Opportunistic Infections (CROI). Presented March 3, 2014.