It is Hard to Keep Track…

of all the new Hepatitis C virus (HCV) studies that are being published.  A recent study shows that the combination of sofusbuvir with either ledipasvir or GS-9669 was effective for HCV genotype 1 infections (Gastroenterol 2014; 146: 736-43).

Two years ago publication of this study would have been met with incredible enthusiasm.  However, now this study, while important, is part of a big trend showing that oral HCV therapies are going to make the treatment of HCV easier, safer, and expensive.  Ledipasvir (LDV) is a NS5A inhibitor and  GS-9669 is a NS5B non-nucleoside inhibitor.

The particulars of this study:  113 patients were enrolled.  All patients received sofusbuvir (400 mg daily).  LDV was dosed at 90 mg daily and GS-9669 at 500 mg daily.  Three of the four treatment arms used ribavirin (RBV) with 1000 mg for those patients <75 kg and 1200 mg for those patients >75 kg.

Four arms:

  1. SOF/LDV/RBV 12 weeks–n=25 treatment-naive (TN)/n=9 null responders (NR)
  2. SOF/GS-9669/RBV 12 weeks –n=25 TN/10 NR
  3. SOF/LDV or SOF/LDV/RBV 12 weeks–n=19 NR with cirrhosis
  4. SOF/LDV/RBV for 6 weeks –n=25 TN (noncirrhotic)

Key Results:

  • Group 1 had SVR12 of 100%, group 2 had SVR 12 of 92%, and group 4 (6 week Rx) had SVR12 of 68%.
  • Among cirrhotic NR, SVR12 was achieved in 9 (100%) of those with triple therapy (SOF/LDV/RBV) and 7 (70%) of those with SOF/LDV dual therapy.

Take home message: Oral direct-acting agents in combination are effective in all groups of patients affected by HCV, included those with cirrhosis and prior null responders.

An editorial (Clin Gastroenterol Hepatol 2014; 12: 533-36) titled “The End of Hepatitis C” indicates that “interferon-free treatment is likely to become the new standard of care within the next 12-18 months.”  However, the potential price tag for treating 3.2 million infected individuals in the U.S. would be about $270 billion in drug costs alone.

A related NEJM article: (link) “Curing Chronic Hepatitis C –The Arc of a Medical Triumph.”  And another study, (link) Sapphire II, showed the effectiveness of other oral agents for HCV.  This study examined ombitasvir, ritonavir, and dasabuvir in 394 patients.

More HCV study results will be reviewed later this week on this blog.

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2 thoughts on “It is Hard to Keep Track…

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