A new drug to treat hepatitis C that’s been hailed as a major breakthrough received FDA approval on Friday, just two weeks after another much-anticipated hepatitis C drug was approved. Sofosbuvir (brand name Sovaldi) is a nucleotide analog inhibitor that blocks a protein the hepatitis C virus needs to replicate.
Sovaldi, made by Northern California-based Gilead Sciences, is the first drug the FDA has approved to treat hepatitis C without the addition of interferon, a drug that must be injected and can cause debilitating side effects. For the many patients who can’t tolerate interferon treatment, Sovaldi – taken as a once-a-day pill – is the breakthrough they’ve been waiting for. Sovaldi is also approved to treat four different genotypes, or strains, of hepatitis C.
Calling it a “landmark advance in the treatment of hepatitis C,” the CDC ‘s director of the Division of Viral Hepatitis, John Ward, MD, said the FDA’s approval of Sovaldi opened up “new opportunities to stop the spread of this virus and the ravages of this disease.”
The FDA approved Sovaldi as part of combination antiviral therapy with either ribavarin alone, or ribavarin and interferon. In the FDA’s announcement, Edward Cox, MD, director of the Office of Antimicrobial Products, called sofosbuvir “a significant shift in the treatment paradigm.”
Without interferon, the only common side effects reported for Sovaldi (with ribavarin) were fatigue and headache. Combination antiviral treatment including peginterferon-alfa caused the typical more serious side effects including nausea, anemia, insomnia, and flu-like symptoms.
Drugs Needed By Millions
The market for Sovaldi and other hepatitis C (also called HCV) treatments is enormous and expected to grow rapidly. More than 3.2 million people are estimated to have chronic hepatitis C and another 17,000 are identified each year, according to the CDC.
In August, 2012, the agency called on all adults between 48 and 68 to get tested for hepatitis C, citing research showing that hepatitis C is rampant among baby boomers, many of whom don’t know they have the disease. The CDC believes such testing could reveal another 800,000 people with the disease and alert them to get treatment. The availability of these new treatments makes this campaign that much more urgent.
Two Weeks, Two Breakthrough Treatments
Two weeks ago, the FDA approved simeprevir (brand name Olysio), another important new treatment option. The difference – at least so far – and the reason sofosbuvir is receiving more attention is that simeprevir was approved for use only in combination with interferon while sofosbuvir can be used without it. The side effects of interferon treatment can be so extreme that many hepatitis C patients have to halt treatment regimens.
Two weeks ago, the FDA approved simeprevir (brand name Olysio), another important new treatment option. The difference – at least so far – and the reason sofosbuvir is receiving more attention is that simeprevir was approved for use only in combination with interferon while sofosbuvir can be used without it. The side effects of interferon treatment can be so extreme that many hepatitis C patients have to halt treatment regimens.
Simeprevir is a protease inhibitor that works by blocking a protein that the virus needs in order to replicate. In clinical trials it was tested in combination with peginterferon-alfa and ribavirin in a combination antiviral regimen.
Simeprevir is now the third protease inhibitor available to treat Hep C; two others, boceprevir (brand name Victrelis, made by Merck) and telaprevir (brand name Incivek, made by Vertex) came on the market in 2011.
Olysio’s maker, Janssen Pharmaceuticals (owned by Johnson & Johnson), announced the drug for treatment of genotype 1 (the most common strain of hepatitis C) with a support page offering tools and resources for patients. Olysio and Solvaldi were actually tested together – without interferon – in a phase 2 clinical trial that showed promising results, but this combination hasn’t been approved by the FDA.
With the two new drug approvals comes a brave new world of Hep C treatment in which the possibility of a cure becomes a reality for patients who’d resigned themselves to a life of chronic disease. “HCV cure just got a whole lot easier,” noted expert Paul Sax, MD, in the journal HIV and ID Observation. “Both have far fewer side effects than any existing HCV drug. Sofosbuvir adds the benefit of having almost zero important drug-drug interactions.”
And there’s more on the way. A five-drug all-oral antiviral “cocktail” from AbbVie is currently in phase 3 clinical trials, and showing promising results, according to HepMag. And all of the new drugs are being tested in multiple combinations in a number of trials.
A Battle Over Cost?
There’s one major problem, though: Many patients won’t be able to afford the new drugs at current prices. A 12-week course of sofosbuvir will cost $80,000. And patients who need 24 weeks of treatment, required for one strain of the virus, will pay $168,000. Simeprevir will also be crazy expensive, with 12 weeks of treatment running $65,000. Pharma watchers like Forbes contributor Ed Silverman have speculated that the high cost of these drugs combined with the number of people who need them could trigger a battle over cost.
There’s one major problem, though: Many patients won’t be able to afford the new drugs at current prices. A 12-week course of sofosbuvir will cost $80,000. And patients who need 24 weeks of treatment, required for one strain of the virus, will pay $168,000. Simeprevir will also be crazy expensive, with 12 weeks of treatment running $65,000. Pharma watchers like Forbes contributor Ed Silverman have speculated that the high cost of these drugs combined with the number of people who need them could trigger a battle over cost.
Sovaldi’s maker, Gilead Sciences, is an independent biotech company that prides itself on its commitment to corporate responsibility to make its drugs accessible to patients who can’t afford them. The company’s page on Sovaldi promises help for patients who can’t afford the drug. Let’s hope this proves true, and that Johnson & Johnson follows their lead.
Source: Forbes - Business
Source: Forbes - Business
