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Though labeled hepatotoxic (liver-damaging), the FDA has approved a very limited use of a drug, eltrombopag, for low platelets in chronic hepatitis C. GlaxoSmithKline (GSK) announced on Nov. 19 that ‘Promacta’, marketed internationally as ‘Revolade’, had been approved by the FDA “for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.” The use is very limited, however, as the drug ” should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy.” The trials involved 1521 patients with platelet counts under 75,000 (or 75 giga/L).
While the two Phase III trials on which this decision was based used ribavarin in addition to peginterferon (both alfa2a and alfa2b), safety and efficacy has not yet been established for treatment with Direct-Acting Antivirals (such as telaprevir and boceprevir).
There are more side-effects and more rules for patients to follow (such as not taking the medication within 4 hours of dairy products or antacids). There is also greater risk for those with cirrhosis or heart problems. Consequently more patient monitoring is required.
However this is really great news for the 3.5% of hepatitis C patients who have been unable to consider treatment due to low platelets. For more information, click HERE (http://www.gsk.com/media/press-releases/2012/FDA-approves-new-indication-for-PROMACTA-eltrombopag.html).