Μια νέα εποχή ανοίγει στην θεραπεία της HCV.

[Argirios Argiriou]

December 30, 2014

Abigail Zuger, MD
The newest drugs to combat hepatitis C virus infections are very effective … and very expensive.

Just as 1996 was a watershed year in treating HIV infections, so 2014 has seen a sea change in treating hepatitis C virus (HCV) infections, with unwieldy, often ineffective treatments suddenly giving way to convenient, well-tolerated, remarkably effective alternatives.

Two components of these new regimens were approved late in 2013: simeprevir (Olysio), a second-generation protease inhibitor; and sofosbuvir (Sovaldi), a polymerase inhibitor. Although both were released only for use in combination with interferon alfa and ribavirin, several industry-sponsored studies published this year suggest that both of these toxic old drugs are now happily obsolete.

In a trial in which researchers enrolled only patients with genotype 1 infections (the most common genotype in the U.S. and the most difficult to treat), 167 patients were randomized to receive the combination of simeprevir and sofosbuvir with or without ribavirin. More than 90% of patients achieved sustained virologic responses, regardless of prior treatment experience, subtype of virus, presence of cirrhosis, or receipt of ribavirin. Serious adverse events were seen in only 2% of patients (NEJM JW Gastroenterol Aug 11 2014).

In three other studies, about 2000 patients with genotype 1 infections received sofosbuvir in combination with ledipasvir, an oral drug that inhibits a different viral protein. Again, response rates exceeded 90% even for treatment-naive patients randomized to only 8 weeks of therapy. Neither history of treatment failure nor presence of cirrhosis significantly affected treatment results, and side effects of the drugs were uniformly tolerable (NEJM JW Gen Med Apr 24 2014).

The combination of ledipasvir and sofosbuvir was approved by the FDA at the end of 2014 as a single daily pill (Harvoni). Additional oral, well-tolerated, effective drugs are still in the pipeline.

Despite these triumphs, serious questions about treating patients with HCV infections remain. Most stem from treatment cost: Complete courses of the new combinations can cost US$100,000 or more (NEJM JW Gen Med Apr 24 2014). These charges fuel an ongoing debate about who should prescribe the drugs, who should receive them, and the optimal duration of treatment. At present, many insurers are releasing the new drugs only to physicians with documented experience in treating HCV and, even then, only for patients with clear HCV-related liver damage. Whether market competition will ease these constraints in coming years remains to be seen.

EDITOR DISCLOSURES AT TIME OF PUBLICATION

Disclosures for Abigail Zuger, MD at time of publication
Editorial boardsNew York Times; Clinical Infectious Diseases

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