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Harvoni: why hep c focus is a plus for benitec

Harvoni: Why hepatitis C focus is a plus for Benitec
With Gilead's announcement in October of FDA approval for Harvoni, Benitec's
Senior Vice President of Research & Development, Dr David Suhy, explains why
putting Hepatitis C in the spotlight is good for Benitec.
Hepatitis C: snapshot
When considering the Hepatitis C is a liver disease caused by the hepatitis impact of Harvoni on the C virus (HCV). According to the World Health potential hepatitis C Organisation, 130-150 million people suffer from market for TT-034, the disease worldwide with 350,000 to 500,000 factors such as cost, dying each year1. compliance, re-infection and mode of action need There are about 13 million sufferers in the Americas and Europe, with the highest disease prevalence in the Middle East, Africa and Asia2. In the USA, over A sizeable price tag
50% of intravenous drug users suffer hepatitis C3, In the USA, a 12-week which is spread via the blood. course of Harvoni will ".present focus on
Harvoni: what Gilead says
cost US $94,500 or US hepatitis C serves to hint
$1,125 per day10 Harvoni is a once-a-day tablet treatment for at the scale of the
compared to Gilead's Hepatitis C Genotype 1, which was approved by the opportunity for Benitec"
predecessor Sovaldi (US US FDA in October 20144. Harvoni combines ledipasvir and sofosbuvir (trade name Sovaldi) to block replication of the virus. For those with private health insurance, the Journal of the American Medical Association Harvoni eliminates the need to also take Ribavirin estimates that the cost of new HCV therapeutics and Interferon, previously part of double or triple could increase each person's premium by up to US therapies with Sovaldi, and is currently prescribed to $300 per year over the next five years11. be taken over 12-24 weeks5. Treatment combinations containing Ribavirin and Interferon For the uninsured in the United States, about have been noted to cause fatigue, headache, 750,000 hepatitis C sufferers receive state-funded nausea, insomnia and anemia6 which increased healthcare through Medicaid or the prison patient withdrawal and decreased cure rates. system. Based on Sovaldi pricing, earlier this year Express Scripts estimated that the USA would foot Harvoni has cure rates of between 99.1% and 94%7 a bill of US $55.2 billion if all States made that and a treatment period of eight, 12 or 24 weeks. The regimen available12. Given the higher price for duration of prescribed treatment depends on the Harvoni, one would assume the bill for the newer patients' treatment history, cirrhosis status and viral treatment would also be higher. load; the eight week period could be applied to treatment-naïve patients without cirrhosis and with a low baseline HCV viral load8. While the side effects of Harvoni are said to be less severe than the Ribavirin, Interferon and Sovaldi Gilead; Oct 10, 2014 5.Ibid treatment, the Prescribing Information confirms 6.Patient Information; Sovaldi; Gilead Sciences; Dec 2013 they still include fatigue, headache, nausea, diarrhea 7.Gilead; Op Cit 8.Gilead; Op Cit 9.Prescribing Information for Harvoni; Gilead; Oct 2014 New York Times; Oct 10, 2014 reported by Seattle Contact us: (02) 9555 6986
Post-Intelligencer Express Scripts; Jul 17 2014.

Harvoni: Why hepatitis C focus
is a plus for Benitec
Because it has only recently gained regulatory With Harvoni and other multiple-dose treatments, approval, it's not clear how many US insurance if patients become re-infected, they will have to companies will offer reimbursement for the Harvoni commence a new course. This obviously increases treatments. With Sovaldi, some insurers offer the cost and duration of treatment. cheaper alternatives that have more side effects and The mode of action of Benitec's TT-034 is quite less efficacy, and offer the more expensive drug only different and overcomes the problem of patient to the most severe cases13. re-infection. TT-034 directs patients' liver cells to Benitec's intention has always been to develop continuously produce their own molecules to ‘turn effective drugs that will be accessible in target off' replication of HCV, for as long as the liver cells markets. Whilst it is far too early to be specific, we live. Thus, TT-034 is designed not only to clear the expect a single dose of TT-034 to be priced infection from the liver, but to provide prophylaxis competitively to 56-168 doses, the number of pills and protect the patient's liver from re-infection by required for a 8-week or 24-week course of Harvoni. HCV for months or even years, from a single dose. Compliance: reality bites
Hep C: a hint of things to come
A key factor in treatment efficacy is compliance Approval of Harvoni has moved hepatitis C, its (continuing to take the drug) and it has to be quite prevalence and significant cost of cure into the high; for instance, with anti-retroviral drugs for HIV, spotlight. However, when compliance and cure compliance needs to be 95% or above for the drugs rates are put into perspective, the benefits of a to be effective at suppressing AIDS14. During all lower cost, single dose alternative therapeutic like clinical trials, patients are very closely monitored, so TT-034 become clearer. The added benefit of compliance rates and therefore cure rates are protection against re-infection is compelling. usually very high. It is accepted that once drugs reach the market, compliance tends to drop. The implications for Benitec of a successful TT-034 clinical trial are far broader than hepatitis C. Small Once drugs are approved and out in the community, molecule drugs like Harvoni are designed to treat a wide variety of other factors may come into play one disease. TT-034 is too, but it's based on that effect compliance: forgetting, being away from ddRNAi, Benitec's broad platform for gene- home, being busy, changes in daily routine, silencing. Once ddRNAi technology is proven safe in psychiatric disorders and substance use/abuse15. If man via the TT-034 clinical trial, it can be applied to patients fail to comply yet wish to be cured, they many more disease-causing genes, through a must wait a period and start the treatment again, simple sequence change. thereby potentially doubling the cost, increasing the Clearly, ddRNAi has sizable potential beyond treatment period and, presumably, skewing the cure rates. hepatitis C. In fact, present focus on that disease serves to hint at the scale of the opportunity for For Harvoni, patients must take multiple doses (56, Benitec. This is already occurring: our other in- 84 or 168 over eight, 12 or 24 weeks) and maintain house programs based on ddRNAi - hepatitis B, high compliance to achieve cure. By contrast, drug resistant lung cancer, age-related macular Benitec's TT-034 for hepatitis C is administered in a degeneration - are progressing towards the clinic, single infusion, thus compliance or lack thereof will by leveraging off the knowledge gained with not be a factor in treatment success. TT-034, the first in man Hepatitis C therapeutic. Re-infection: <25% in some populations
David Suhy PhD
Another factor for success is patient re-infection. With Hepatitis C in gay men, the re-infection rate is up to 25%16with secondary re-infection 13.New York Times; Op Cit. reported at 23%17. JBI Library of Systematic Reviews 16 Medscape Medi Contact us: (02) 9555 6986 cal News, Jul 11, 2013
17 PubMed. Oct 2013

Source: http://benitec.blackroom.com.au/documents/short-insights/1411_Harvoni_Why_Hep_C_Focus_is_a_Plus_for_Benitec.pdf