Hep C News

ANOTHER NEW TREATMENT RECOMMENDED

In July 2016 the Pharmaceutical Benefits Advisory Committee (PBAC) recommended that another new Direct Acting Antiviral (DAA) combination hepatitis C treatment be made available on the Pharmaceutical Benefits Schedule (PBS): Zepatier® (grazoprevir/elbasvir).

Zepatier has completed trials in people with HIV/HCV co-infection and in a cohort of people with bleeding disorders, with high cure rates, few side effects and good safety in people with bleeding disorders. (1,2) An important difference is that Zepatier is effective in genotypes 4 and 6 as well. The PBAC took this into account in its recommendation, saying that there is “a clinical need for treatment regimens that do not contain peg-interferon” and recommended Zepatier as an interferon-free treatment for these genotypes. However, the PBAC did not recommend listing Zepatier to treat genotype 3 due to “insufficient data.”

This recommendation will now go to the Australian Government Minister for Health to consider pricing matters and make a decision about funding for the new medications to go on the PBS.

There are now several new hepatitis C treatments listed on the PBS in Australia. Some are used in combination with each other:

• Harvoni® (sofosbuvir with ledipasvir)
• Sovaldi® (sofosbuvir)
• Daklinza® (daclatasvir)
• Viekira Pak® (ombitasvir, paritaprevir, ritonavir, dasabuvir – tablets with or without ribavirin)
• Ibavyr® (ribavirin).

Treating people with HCV genotype 3 is still an area where clinicians think there could be some improvement. With the current treatments available in Australia cure rates for genotype 3 are slightly lower than those for genotype 1.

Presentations on hepatitis C treatment at the WFH World Congress spoke of the impressive cure rates of the new DAA treatments across all genotypes, and also mentioned another new combination treatment velpatasvir/sofosbuvir (Epclusa®) that is highly effective for all genotypes, and also demonstrates increased cure rates in genotype 3.(3,4) Epclusa was approved by the FDA for the treatment of all HCV genotypes in June 2016 and has been prescribed for treatment in the USA. Epclusa is due to go to PBAC for approval in November 2016. HFA will be making a submission to support this.

REFERENCES

1.Rockstroh JK, Nelson M, Katlama C, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV 2015;2(8):e319–e327. doi:10.1016/S2352-3018(15)00114-9

2.Hezode C, Colombo M, Spengler U, et al. C-EDGE IBLD: Efficacy and safety of elbasvir/grazoprevir in patients with chronic hepatitis c virus infection and inherited blood disorders. Presentation at The International Liver Congress™, EASL – European Association for the Study of the Liver, Barcelona, Spain, 13-17 April 2016.

3.Luxon BA. Hepatitis C: what is new in the last several months? Presentation at the WFH World Congress 2016, Orlando, Florida, USA, 24-28 July 2016.

4.Moonka, D. Hepatitis C: History/Overview of disease, available new treatment, and early diagnosis. Presentation at the WFH World Congress 2016, Orlando, Florida, USA, 24-28 July 2016.