Epclusa® received Pharmaceutical Benefits Scheme (PBS) listing on 1st August 2017. Epclusa®, a combination of sofosbuvir and velpatasvir, is the first pan-genotypic interferon-free treatment for hepatitis C.

There are six main genotypes of the hepatitis C virus, all of which respond differently to treatment. The introduction of a pan-genotypic therapy is a welcome development for patients with genotypes that are more difficult to treat and for those with mixed genotype infection. It is also expected to simplify prescribing which may increase uptake, particularly in rural and remote areas.

The efficacy of Epclusa® across genotypes 1, 2, 4, 5, and 6 was investigated in the ASTRAL-1 trial. The results reveal a sustained virologic response (SVR) of between 97% and 100%. The ASTRAL-3 trial went on to demonstrate an SVR of 95% for patients with genotype 3 infection. In patients with decompensated cirrhosis, ribavirin was shown to increase the SVR from 83% to 94% overall. This effect was particularly marked for patients with genotype 3 infection.

Epclusa® was well tolerated during clinical trials, with only 0.2% of patients permanently discontinuing treatment due to adverse events. The most common adverse events reported were headache, fatigue, nausea, and nasopharyngitis. As with other direct-acting antivirals, appropriate monitoring should be performed for all patients co-infected with hepatitis B.

Almost 40,000 Australians have begun therapy for hepatitis C since the introduction of highly-effective antivirals to the PBS in March 2016. A report released by the Kirby Institute suggests that Australia is now on track to eliminate hepatitis C by 2026.

References:

  1. Curry MP, O’Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. New Engl J Med. 2015; 373(27): 2618-28.
  2. Epclus® (sofosbuvir/velpatasvir) Australian approved product information. Melbourne: Gilead Sciences. Approved December 2016.
  3. Feld JJ, Jacobson IM, Hézode C, Asselah T, Ruane PJ, Gruener N, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. New Engl J Med. 2015; 373(27): 2599-607.
  4. Foster GR, Afdhal N, Roberts SK, Bräu N, Gane EJ, Pianko S, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. New Engl J Med. 2015; 373(27): 2608-17.
  5. Kirby Institute, Hepatitis Australia, Doherty Institute. Australia leads the world in curing hepatitis C as record numbers treated. Kensington: Kirby Institute; 2016.

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