End of Hepatitis C by 2030?

[Guest StevenDraker]

Hepatitis C , eradicated by 2030?

New combination drug therapy proves very effective in hepatitis C treatments

Date:

April 12, 2014

Source:

Beth Israel Deaconess Medical Center

Summary:

Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

A new 12-week single tablet regimen of ledipasvir and sofosbuvir have proven to be highly effective in treating a broad range of patients with HCV genotype 1, a form of the virus found in up to 75 percent of infections, according to results unveiled today at the European Association for the Study of the Liver and published simultaneously online by the New England Journal of Medicine.

Between 94 percent and 99 percent of patients were cured of hepatitis C and results were similar in patients who have never been treated and for those who had previously been treated with a combination of peginterferon and ribavirin, the current course that carries sometimes significant side effects.

“Eliminating interferon and ribavirin from treatment regimens is expected to reduce the incidence and severity of adverse events, to simplify the treatment of patients with HCV infection and to provide an option for patients who are ineligible for the current interferon-based treatments,” said Nezam Afdhal, MD, the senior author of the studies, Director of the Liver Center at Beth Israel Deaconess Medical Center and a Professor of Medicine at Harvard Medical School.

Hepatitis C is an infectious disease primarily affecting the liver and which can lead to scarring and cirrhosis and is transmitted primarily through blood transfusions (prior to 1991), intravenous drug use, poorly sterilized medical equipment and sexual transmission.. After exposure 80 percent of patients develop a chronic hepatitis which can lead to cirrhosis, liver failure and liver cancer and hepatitis C is the most common cause for liver transplantation in the US.

Prior treatments have been with interferon which is an injectable cytokine released in response to viral infections. Interferon is combined with other antiviral agents and needs to be used for up to 48 weeks to cure hepatitis C. but is associated with number of side effects, including influenza-like symptoms depression and anemia. Many patients are ineligible for these interferon-based therapies.

“The real advances seen in the Ion trials is that the sofosbuvir-ledipasvir combination tablet enables us to treat almost all genotype 1 patients with a short duration of 8-12 weeks of treatment expanding the treatment pool and increasing the overall cure rate,” said Afdhal.

Recent recommendations by the CDC and endorsed by the USPHS Task force have recommended screening of baby boomers (persons born between 1945 and 1965) for hepatitis C since up to3 percent may have silent infection without symptoms.

“Screening for HCV needs to be associated with a safe and effective treatment for these “baby boomers” with newly identified HCV and the ION trials clearly give an exciting new option for these patients” stated Afdhal.

ION-1 (865 patients) and ION-2 (440 patients) evaluated 12 and 24 weeks of sofosbuvir-ledipasvir single dose treatment for 12 versus 24 weeks either with or without ribavirin in patients who had never been treated (ion 1) and in prior treatment failures (Ion 2). Both studies showed that 12 weeks of sofosbuvir and ledipasvir without ribavirin was adequate to cure over 95 percent of patient with hepatitis C.

The trials were funded by Gilead Sciences and were multicenter and multinational trials (see published addendum of sites and principal investigators).

source: http://www.sciencedaily.com/releases/2014/04/140412145859.htm

[Guest StevenDraker]

A new pill to treat Hepatitis C raises difficult questions about fair pricing, not only in the United States and other affluent nations but in developing countries around the world. Hepatitis C, which afflicts some 150 million people globally, often without symptoms for years, can cause fatigue and fever, cirrhosis or liver cancer.

The pill, known as Sovaldi, or generically as sofosbuvir, costs $84,000 for a standard 12-week course of treatment. That breaks down to $1,000 for each pill, taken daily. The manufacturer, California-based Gilead Sciences, says private insurers are already covering Sovaldi. The question is whether insurers and public programs like Medicare and Medicaid should have to pay so much for this drug, driving up costs for taxpayers and private policyholders.

more: http://www.nytimes.com/2014/03/16/opinion/sunday/how-much-should-hepatitis-c-treatment-cost.html?_r=0

[Guest PasadenaCA]

It's a tough issue. It turns out that the news on Hep C continues to get better. The drug from Vertex approved a few years ago, cleared the virus out of the system in some patients. Merck recently release good news on an investigational new drug.

The treatments are expensive and likely will remain so. For what its worth, even at $80k, it's likely less expensive than the alternative--the care that has to be afforded to a patient as the liver function starts to deteriorate.

The bigger issue in the pharmaceutical industry is where the R&D programs are headed. Cardiovascular used to be the big area, now it's oncology. Companies can develop drugs based on the response of a marker, survivability is still a focus, but it's less than a cure. Side effects, adverse events, aren't viewed as critically in the oncology market by many agencies, so companies have more leeway.

Many programs now target orphan indications. Here the course of treatment can be very costly, but the patient population is low. While there is ongoing research in all the traditional areas, the dollars spent, worldwide, has declined in the last decades. Pharma has moved from targeting life-threatening illnesses to life-style threatening conditions. The joke ten years ago, is that pharma is focused on the three H's: they want to make people happy, hairy and horny.

The bottom line is that if you chance the regulatory landscape, pharmaceutical companies follow; hence, the move into oncology and orphan indications over the past ten years. It wouldn't surprise me to see companies try to slice and dice diseases--have certain types of patients, based on genetic markers, reclassified, in an effort to convert a subgroup into an orphan population.

There is good news in that research on antibiotics has gained traction in the past few years. Antibiotic research was largely abandoned by big pharma and relegated to a backwater. Things have changed. The FDA is now much more interested in the development of new treatments. There are now about a dozen, serious emerging pharmaceutical companies working on novel antibiotics. They're not a as lucrative as other franchises: antibiotics cures something; almost all other drugs treat a condition.

Drugs will continue to be expensive, but in the US just under 10% (and dropping) of the total healthcare spend is on pharmaceuticals. It's not a bad bang for the buck.