Monitoring hepatitis C treatment uptake in Australia Issue #8 December 20171 An estimated 43,360 individuals initiated direct acting Initiations of new antiviral (DAA) treatment for chronic hepatitis C virus (HCV) infection through Pharmaceutical Benefits Scheme (PBS) between March 2016 and June 2017, equating to 19% of treatment for the people living with chronic HCV infection in Australia. Of individuals initiating DAA treatment in this period, 66% chronic hepatitis were men, 54% were >50 years old, and 27% had cirrhosis. The most commonly prescribed regimen was sofosbuvir/ ledipasvir for 53%, followed by sofosbuvir+daclatasvir C from March for 39%. Of individuals initiated on sofosbuvir/ledipasvir, 16% were prescribed an 8-week course, 75% a 12-week course, and 10% a 24-week course. Of individuals initiated 2016 to June on sofosbuvir+daclatasvir, 67% were prescribed a 12-week course, and 33% a 24-week course. Overall, 57% of individuals 2017 were prescribed DAA treatment by specialists (46% by gastroenterologist, 7% by infectious diseases physicians, and 4% by other specialist), while 22% of individuals were prescribed DAA treatment by general practitioners (GPs). The proportion of individuals prescribed DAA treatment by GPs increased from 8% in March 2016 to 39% in June 2017. Of individuals initiated on 8 weeks sofosbuvir/ledipasvir, 40% were prescribed treatment by specialists while 60% were prescribed treatment by non-specialists (34% by GPs). Of individuals prescribed on 24 weeks sofosbuvir/ledipasvir or 24 weeks sofosbuvir+daclatasvir, 69% were prescribed treatment by specialists while 31% were prescribed treatment by non-specialists (10% by GPs). 1. The Kirby Institute. Monitoring hepatitis C treatment uptake in Australia (Issue 8). The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia, December 2017 (available online at: https://kirby.unsw.edu.au/report/monitoring-hepatitis-c-treatment-uptake-australia-issue-8-december-2017). For more information, contact Professor Greg Dore ([email protected]) or Dr Behzad Hajari ([email protected]). Issue #8 1 New treatments for chronic hepatitis C virus (HCV) Issue #8 newsletter provides data on: infection, named direct acting antiviral (DAA) • Uptake of DAA treatment through PBS-listing treatment, were listed on the Pharmaceutical Benefits between March 2016 and June 2017 by jurisdiction, Scheme (PBS): patients’ gender and age, treatment regimen, and • March 2016: Sofosbuvir/ledipasvir (Harvoni®), prescriber type sofosbuvir+daclatasvir (Sovaldi®+Daklinza®), • Proportion of individuals living with chronic HCV sofosbuvir+ribavirin (Sovaldi®+Ibavyr®), and infection and those with cirrhosis initiating DAA sofosbuvir+pegylated interferon-alfa-2a+ribavirin treatment between 2014 and June 2017 through PBS-listing (2016-17) and early DAA access (Sovaldi®+Pegasys®+ribavirin) avenues (2014-15). • May 2016: Paritaprevir/ritonavir/ ombitasvir+dasabuvir (Viekira PAK®) • January 2017: Elbasvir/grazoprevir (Zepatier®) • August 2017: Sofosbuvir/velpatasvir (Epclusa®)2 Figure 1: The estimated number of individuals initiating DAA treatment (bar charts) and the proportion of individuals living with chronic HCV infection who initiated DAA treatment (pie charts) during March 2016 to June 2017, by jurisdiction. 19% 19% 18% 24% 16% 30% 25% 12% 16000 15000 14000 13000 12000 11000 10000 9000 8000 7000 6000 initiating treatment 5000 4000 3000 Estimated number of individuals 2000 1000 0 NSW VIC QLD SA WA ACT TAS NT NSW: New South Wales; VIC: Victoria; QLD: Queensland; SA: South Australia; WA: Western Australia; ATC: Australian Capital Territory; TAS: Tasmania; NT: Northern Territory 2. Data on sofosbuvir/velpatasvir were not included in this issue. Issue #8 2 DAA treatment uptake Figure 2: Estimated proportion of individuals living with An estimated 43,360 individuals initiated DAA chronic HCV infection in Australia who initiated DAA treatment through PBS-listing between March 2016 treatment between 2014 and mid-2017, by liver fibrosis stage and June 2017 in Australia, including 15,470 in New 100% South Wales, 10,770 in Victoria, 8,400 in Queensland, Not-treated 2,780 in South Australia, 3,320 in Western Australia, 90% PBS (March 16 1,070 in Australian Capital Territory, 1,130 in - June 17) 80% Tasmania, and 430 in Northern Territory (Figure 1)3 Generic (2015) 70% Clinical Trials In 2015, an estimated 227,310 individuals were living (2014-15) with chronic HCV infection in Australia4, among whom 60% Pharmaceutical 19% initiated DAA treatment through PBS-listing company 50% between March 2016 and June 2017. This proportion compassionate access varied between 12% and 30% across jurisdictions 40% programs (Figure 1). (2014-15) 30% Between 2014 and mid-2017, an estimated 47,700 20% individuals, equating to 21% of the people living with chronic HCV infection in Australia, received DAA 10% treatment through PBS-listing, and early DAA access 0% avenues, including clinical trials, pharmaceutical F0-F3 F4 company compassionate access programs, and (n=207,130) (n=20,180) generic importation. Among total population living with chronic HCV infection in Australia in 2015, an estimated 69% of those with cirrhosis (n=14,020) and 16% of those without cirrhosis (n=33,680) initiated DAA treatment up to June 2017 (Figure 2). The monthly trends of DAA treatment uptake in Australia and in each jurisdiction are illustrated in Figure 3. After an initial decreasing trend, the monthly number of DAA initiation reached a relatively steady pattern from October 2016. The initial decline in treatment uptake was consistent with a “warehouse” effect with a large number of patients in specialist clinics awaiting DAA treatment access initiating treatment in the early months. 3. For an estimated 10 individuals, more than one jurisdiction was recorded. 4. The Kirby Institute. Hepatitis B and C in Australia Annual Surveillance Report Supplement 2016. The Kirby Institute, UNSW Sydney, Sydney NSW 2052 Issue #8 3 Figure 3: Estimated number of individuals initiating DAA treatment in each month during March 2016 to June 2017 in Australia (A), and by Jurisdiction (B and C) 5500 Figure 3A 5000 4500 4000 3500 3000 2500 2000 initiating treatment 1500 Estimated number of individuals 1000 500 0 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16 Jan 17 Feb 17 Mar 17 Apr 17 May 17 Jun 17 1800 Figure 3B NSW VIC 1600 QLD 1400 1200 1000 800 initiating treatment 600 400 Estimated number of individuals 200 0 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16 Jan 17 Feb 17 Mar 17 Apr 17 May 17 Jun 17 350 Figure 3C SA WA ACT 300 TAS NT 250 200 150 initiating treatment 100 Estimated number of individuals 50 0 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16 Jan 17 Feb 17 Mar 17 Apr 17 May 17 Jun 17 NSW: New South Wales; VIC: Victoria; QLD: Queensland; SA: South Australia; WA: Western Australia; ATC: Australian Capital Territory; TAS: Tasmania; NT: Northern Territory Issue #8 4 Gender and age distribution living with chronic HCV infection in Australia, a shift of individuals initiating DAA treatment towards older age groups was observed among those initiating DAA treatment (Figure 4). Of individuals initiating DAA treatment between March 2016 and June 2017, 66% were men and The age distribution of individuals initiating DAA 34% were women. treatment in each month showed a trend towards younger age groups from March to September 2016, Age distribution of individuals initiating DAA treatment while a relatively constant age distribution has been was similar between men and women (Figure 4). observed since then (Figure 5). An estimated 28% The highest proportion of total individuals were 51-60 of individuals initiating DAA treatment in March 2016 years old (37%), followed by 41-50 years old (25%). as opposed to 55% of those initiating DAA treatment Compared to the age distribution of the total population in June 2017 were ≤50 years old. Figure 4: Age distribution of individuals living with chronic HCV infection in 2015 (dotted line) and those initiating DAA treatment during March 2016 to June 2017 (bars) 40% Men 35% Women 30% Estimated age 25% distribution of people living with chronic HCV infection in Australia 20% 15% 10% 5% 0% <21 21-30 31-40 41-50 51-60 61-70 >70 Age group Issue #8 5 Figure 5: Absolute frequency (A) and relative frequency (B) of age groups of individuals initiating DAA treatment in each month during March 2016 to June 2017 5500 Figure 5A ≤30 5000 31-40 4500 4000 41-50 3500 51-60 3000 ≥61 2500 2000 initiating treatment 1500 Estimated number of individuals 1000 500 0 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16 Jan 17 Feb 17 Mar 17 Apr 17 May 17 Jun 17 Figure 5B 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16 Jan 17 Feb 17 Mar 17 Apr 17 May 17 Jun 17 Distribution of DAA regimens prescribed Figure 6: Distribution of DAA regimens prescribed during for individuals initiating DAA treatment March 2016 to June 2017 The most commonly prescribed regimen was 3% 1% 4% sofosbuvir/ledipasvir±ribavirin for 53%, followed by SOF/LDV±RBV sofosbuvir+daclatasvir±ribavirin for 39%, elbasvir/ grazoprevir±ribavirin for 3%, and paritaprevir/ritonavir/ SOF+DCV±RBV ombitasvir+dasabuvir±ribavirin for 1%. For 4% of 39% EBR/GZR±RBV individuals, other DAA treatment regimens were prescribed (Figure 6). PrOD±RBV 53% Other regimens SOF: Sofosbuvir; LDV: Ledipasvir; DCV: Daclatasvir; EBR: Elbasvir; GZR: Grazoprevir; PrOD: Paritaprevir/ritonavir/Ombitasvir+Dasabuvir; RBV: Ribavirin Issue #8 6 The breakdown of treatment initiation numbers by treatment regimen and treatment course duration Figure 7: Distribution of DAA regimens prescribed is shown in Figure 7.