HCV UPDATE Treatment: The Next Wave Access: Myths & Facts NASTAD National Technical Assistance Meeting October 2015 Tracy Swan

Transcription

1 HCV UPDATE Treatment: The Next Wave Access: Myths & Facts NASTAD National Technical Assistance Meeting October 2015 Tracy Swan

2 HCV Treatment Characteristics of DAA Classes Next-generation: FDCs Trends: 3somes and Quickies HCV Treatment in HIV/HCV

3 DAA CLASSES NON-NUCLEOSIDE POLYMERASE INHIBITORS (Dasabuvir): G1 only, further development/need?? PROTEASE INHIBITORS (Paritaprevir/r, Olysio): Usually G1 and G4, tendency for DDIs, possibly more side effects, resistance may not always be persistent next generation might be pan-genotypic

4 DAA CLASSES NS5A INHIBITORS (Daclatasvir, Ledipasvir, Ombitasvir, Velpatasvir) : pan/multi-genotypic (less information in G4, G5 and G6) some DDIs, resistance can persist for >2 years stop them from working--next generation more potent, active against resistance? NUCLEOSIDE/TIDE POLYMERASE INHIBITORS (Sofosbuvir): pan/multi-genotypic (less information in G4, G5 and G6), few DDIs, resistance does not seem to be a major problem; a few more are finally in development

5 Fixed-Dose Combinations (FDCs) WHAT S HERE NOW. Sofosbuvir + Ledipasvir Paritaprevir/r + Ombitasvir, w/ Dasabuvir WHAT S COMING in Grazoprevir + Elbasvir Sofosbuvir+ Velpatasvir

6 What s Coming in 2016 once daily DAA fixed-dose combinations, 12 weeks* Grazoprevir/Elbasvir adults w/ G 1,4 and 6 (TXnaive or -experienced, HIV/HCV; in people w/ cirrhosis or ESRD, and w/ost) ---cure rates generally >90% Sofosbuvir/Velpatasvir adults with all HCV genotypes (TX-naive or -experienced, people with cirrhosis) ---cure rates generally >90% *some people may need longer treatment and/or ribavirin

7 Trend: Couples and 3somes ABT ABT-493 Sofosbuvir/Velpatasvir + GS-9857 Grazoprevir + MK Elbasvir or MK-8408 Odalasvir + AL Olysio

8 Trend: Quickies Sofosbuvir/Velpatasvir + GS-9857 for 4 or 6 weeks Grazoprevir/Elbasvir + Sofosbuvir for 4, 6 or 8 weeks Sofosbuvir + Odalasvir for 6 or 8 weeks

9 G1: Sofosbuvir/Velpatasvir + GS weeks 6 weeks 6 weeks 6 weeks Gane et al;.easl 2015

10 G1: Grazoprevir/Elbasvir + Sofosbuvir Poordad et al; EASL 2015

11 G3: Grazoprevir/Elbasvir + SOF 8 weeks 12 weeks 12 weeks Poordad et al; EASL 2015

12 G1: Sofosbuvir + Odalasvir: for 6 or 8 weeks Patel et al; EASL 2015

13 Treating HCV in HIV/HCV Cure rates are the same-- sometimes even better Drug-drug interactions between ARVs and DAAs can complicate HCV treatment extra monitoring may be needed; some drugs need to be switched

14 Sofosbuvir/Ledipasvir (Harvoni) in HIV/HCV, G1 or G4, TX-naive or -experienced ARVs: Atripla or Edurant/ Isentress + Truvada Cooper et al; IAS 2015

15 ALLY-2: Sofosbuvir/Daclatasvir in TX-naive or -experienced, HIV/HCV G1, 2, 3,4 ARVs: all, except Aptivus Wyles et al; CROI 2015

16 Grazoprevir/Elbasvir in HIV/HCV G1 or G4, TX-naive ARVs: Edurant, Tivicay, Isentress + nucleosides/tides Rockstroh et al; EASL 2015

17 ACCESS OVERVIEW Benefits of HCV cure US HCV treatment guidelines HCV Treatment Access: Myths and Facts DAAs: pricing versus cost

18 WHY being cured matters People feel better (duh) Uncured HCV can cause systemic health problems Being cured lowers: risk of liver-related illness or death also true for people w/ cirrhosis, HIV/HCV risk of death from all causes also true for people w/ cirrhosis, HIV/HCV risk of AIDS-related illness or death for HIV+ people Adiolfi, et al; W J Gast 2015; Berenguer, et al; JAIDS 2012; Berenguer, et al; CID 2012; Branch, et al; CID 2012; Cacoub et al; Dig Liver Dis 2014 Mira et al; CID 2013

19 WHY being cured matters Hepatitis C increases health care costs and hospitalization rates even in people who do not have serious liver damage Being cured lowers health care utilization and costs Mc Adam-Marx et al; J Mang Care Pharm; Manos et al; J Mang Care Pharm 2013; McCombs et al; Clin Ther 2011

20 HCV Treatment Guidelines "The goal of treatment is to reduce allcause mortality and liver-related health adverse consequence by the achievement of virologic cure. Treatment is recommended for patients with chronic HCV infection. AASLD/IDSA Recommendations for Testing, Managing and Treating HCV

21 HCV Treatment Access Myths and Facts

22 Trouble started with.. Based on available resources, immediate treatment should be prioritized as necessary so that patients at high risk for liver-related complications and severe extrahepatic hepatitis C complications are given high priority. AASLD/IDSA Recommendations for Testing, Managing and Treating HCV 2014

23 State Medicaid Programs: Sofosbuvir Access, by Fibrosis Stage F3 and F4 ONLY: 30/42 NO FIBROSIS-BASED RESTRICTION: 8 /42 (Alabama, Massachusetts, Minnesota, Mississippi, North Carolina, Nevada, Utah, and Wyoming) Barua et al; Ann Inter Med 2015

24 Sofosbuvir: State Medicaid Eligibility, by Fibrosis Stage Barua et al; Ann Inter Med 2015

25 Myth: Prioritizing Fact: Rationing We are waiting too long to treat people Health, QoL compromised A cure is less likely Risk for HCC remains Early treatment > effective Doctors deserve a chance to cure people!

26 What message are we sending? Would we tell an HIV+ person that they had to wait to develop AIDS before they could be treated?

27 MYTH: STAMPEDE! Everyone w/ HCV in the US will storm health care systems, demanding immediate treatment

28 FACT: First, You Need to Know if You Have HCV In the US, 45% to 85% of people with hepatitis C have not been diagnosed Smith et al; Ann Intern Med 2012

29 Myth: People who inject drugs should not be treated for HCV unless they have already stopped doing so for a while bias about adherence lack of data from DAA clinical trials creates vicious cycle concerns about reinfection

30 80% OF NEW INFECTIONS OCCUR AMONG CURRENT PWID PEOPLE LIVING WITH HCV INFECTION Slide Courtesy of Dr Greg Dore, Kirby Institute NSW

31 60% OF EXISTING INFECTIONS ARE AMONG CURRENT & FORMER PWID PEOPLE LIVING WITH HCV INFECTION Slide Courtesy of Dr Greg Dore, Kirby Institute NSW

32 Fact: Most HCV cases in the US are from injection drug use Injection drug use is becoming more common among young people Not everyone wants to or can stop using drugs.and why do they have to? Do we tell people to quit smoking for 3, 6, or 12 months before they can start chemo?

33 Sofosbuvir: State Medicaid Restrictions for Drug/Alcohol Use 88% (37/42) ask about/ restrict access for drug/alcohol use 21 require drug/alcohol testing as a prerequisite for treatment, for all patients, regardless of history 21 require abstinence (1-12 months) for all patients, regardless of history 17 ask about, or require treatment for SUDs 9 require 3 6 months of abstinence for people with a history of SUDs Barua et al; Ann Inter Med 2015

34 Sofosbuvir: State Medicaid Restrictions for Drug/Alcohol Use Barua et al; Ann Inter Med 2015

35 Fact: People who inject drugs can be cured if they are treated Who understands consequences of missed doses more? There is no evidence base for a specifc duration of abstinence (or one that suggests it should be required) People who inject drugs want to be cured Cure rates w/ PEG-IFN are similar, whether people inject drugs during TX or not Aspinall et al; CID 2013; Martin et al; J Viral Hep 2015

36 Myth: Heavy Drinkers Should not be Treated for HCV Until They are Sober Fact: there is no evidence to support this Fact: alcohol use during interferon-based treatment did not lower cure rates Fact: alcohol accelerates liver damage from HCV --- why force drinkers into developing serious liver disease when it could be prevented? Anand et al; Gastroenterol 2006; Shoreibah et al; World J Gastroenterol 2014

37 Sexually Transmitted HCV: The New Epidemic Is not new: Outbreaks of sexually transmitted HCV have been reported among non-idu, HIV+ MSM since 2000 in the UK, Europe, Asia, Australia & the US A cluster of risk factors are associated with HCV among HIV+ MSM Bradshaw et al; Curr Opin Infect Dis 2013; van der Lar et al; Gastroenterology 2009

38 Myth: reinfection risk justifies withholding HCV treatment Myth: No point in treating PWID and HIV + MSM, because they will just keep getting infected Fact: Reinfection rates are not high (13% at 5 years for PWID; 1% to 25% for HIV+ MSM) Fact: Access to prevention (and MSM risk/transmission info) not adequate leading to reinfection Fact: curing people is prevention-- the problem is not what people are doing, it s that we are not treating enough of the people who are at risk How can we stop this epidemic if we don t treat and cure people? Hill et al; CROI 2015

39 Prevention (and Cure) HCV prevention remains important ---and we need more of it More information about HIV + MSM and HCV PaP: prevention as prevention CasP: Cure as prevention: if you treat enough people, the epidemic will shrink

40 DAAs: pricing versus cost

41 What is excessive? If you are making $3 billion/year on (cancer drug) Gleevec, could you get by with $2 billion? When do you cross the line from essential profits to profiteering? Brian Drucker, MD Director, Knight Cancer Institute

42 Myth: HCV treatment is unaffordable Fact: generic DAAs can be massproduced profitably and sold for a few hundred dollars Price vs. cost what factors in? Hill et al. 20th International AIDS Conference 2014

43 5g of diamonds 25 1-carat ($1900 each) Cost = $48,000 5g of daclatasvir 12 weeks of treatment, 60mg/day Cost = $63,000 (US price) Slide: Courtesy of Dr. Andrew Hill

44 Daclatasvir: generic prices Cost of API = $2,000/kg API needed per person = 5g (60mg x 84 days) API per 12 weeks = $10 Formulation = 40% Formulated drug = $14 Packaged drug = $15 Packaging = $0.35/month Profit margin = 50% Slide: Courtesy of Dr. Andrew Hill Final generic Price = $22 For end 2015, Prices falling rapidly

45 Cost (US $) Current costs of sofosbuvir, Per person (12 weeks) $84, $56,000 $53, $27, $7,000 $900 $750 $344 USA USA* UK Spain Brazil LMICs Generic Mini *discount Slide: Courtesy of Dr. Andrew Hill

46 US drug pricing.. Not the right benchmark, anymore, anywhere..for anyone. Myth: AWP is what payers actually spend Fact: Federal law mandates rebates of at least 23%-- to State Medicaid programs They are not paying $84,000

47 Negotiate! After 20 years in the industry the President of Prime Therapeutics ( >25 million members) had never seen prices for a brand-name drug category plummet so quickly after a competing drug was introduced Gilead is telling investors that the increased number of hepatitis C patients treated can make up any shortfalls from lower net prices, since.discounts for the treatments.. will more than double this year to 46%, on average. AbbVie has offered huge discounts in return for exclusivity; signed 25 state deal + 25% to 30% rebate FINAL 1pm.pdf; ;

48 DON T GIVE UP