TREATMENT ACTION GROUP POLICY BRIEF 2021 www.treatmentactiongroup.org Hepatitis C and COVID-19 Global Concerns: Sustained Financing and Expanded Access to Testing and Pangenotypic Treatments Needed to Recover the Path to Elimination By Bryn Gay, Suraj Madoori, Annette Gaudino, and Elizabeth Lovinger Edited by Candida Hadley INTRODUCTION Enormous amounts of public funding and health be leveraged to inform COVID-19 R&D, clinical resources have been reallocated from address- trials, and equitable and affordable access strat- ing the blood-borne hepatitis C virus (HCV) egies. Investments in COVID-19 can also aid with to respond to the novel SARS-CoV-2 virus/ rolling out the HCV response and strengthening COVID-19 pandemic. This has complicated the the capacity and infrastructure needed for both delivery of essential services and made scale-up epidemics. of HCV testing and treatment even less likely. As governments and donors send emergency COVID-19 relief aid to countries and jurisdictions, COVID-19 IS THREATENING THE sustained financing and expanded access to pre- vention, testing, and pangenotypic treatments INCREMENTAL HEPATITIS C PROGRESS for HCV (that treat all genetic variations of the NEARLY EVERYWHERE virus) need to be included to recover the path to Global HCV Diagnosis and Treatment Gaps elimination. We can expect COVID-19 to worsen HCV1 and Investments in research and development of overdose-related2 death tolls because people HCV treatments, diagnostic tools, and lab in- who are disproportionately affected by HCV, frastructure have directly led to the creation of particularly people who use drugs, are more goods that are being put to use for COVID-19. likely to be isolated, miss medical appointments, and lack access to essential support systems. As governments and donors send The pandemic has also interrupted outreach and emergency COVID-19 relief aid to prevention programs, including harm reduction countries and jurisdictions, sustained services, screening campaigns, and routine health visits that confirm HCV diagnoses and identify financing and expanded access to new cases. Interruptions to essential health pro- prevention, testing, and pangenotypic grams are part of efforts to reduce people’s risk treatments for HCV (that treat all of exposure to the SARS-CoV-2 virus. genetic variations of the virus) need Before COVID-19, global treatment uptake to be included to recover the path to among the general population was already elimination. dismal, with a few exceptions, namely Australia, France, Georgia, and Italy (see Figure 1). Since Lessons from HCV on how to address a largely the groundbreaking, highly effective direct-act- undiagnosed and untreated infection that in- ing antiviral (DAA) sofosbuvir (Sovaldi) for HCV cludes numerous barriers between patients and became available in 2013, more than 90%3 (or effective cures can inform policies on accessing 67 million people) of the world’s estimated 71 COVID-19 technologies, such as vaccines. Com- million people living with chronic HCV remain munity engagement and advocacy networks can untreated. 2 TREATMENT ACTION GROUP POLICY BRIEF In the U.S., an estimated 63% of Americans re- generic competition has reduced prices to less main untreated,4 in large part due to high pre- than US$100 per treatment course, with costs scription drug prices, prior authorization require- significantly lower in Egypt, India, and Pakistan. ments by payors, and restrictions against treating High drug prices should no longer be a barrier to individuals who are actively using drugs or alco- treatment; diversifying generic competition and hol or experiencing early stage liver disease. Ge- lifting treatment restrictions in all countries will neric HCV treatments are not as widely available help more people start treatment earlier. Further- and accessible in high-income settings, including more, the lack of international donor funding and in the U.S., due to patent monopolies. Outside national scale-up remain major challenges. high-income countries, within seven years, global Figure 1. Treatment Uptake in 20 Select Countries in 20185,6 Indonesia 0.15% Burundi 0.37% Malaysia 0.68% Russian Federation 0.73% Argentina 0.95% Thailand 1.69% Chile 1.78% Bulgaria 3.37% Tunisia 4.04% Romania 4.20% Lebanon 7.50% Iran, Islamic Rep. 8.58% Rwanda 11.42% Brazil 11.67% Poland 13.17% Pakistan 14.43% United Kingdom 14.55% Italy 19.76% Georgia 25.73% Australia 32.17% France 33.14% 0 5 10 15 20 25 30 35 Interim progress reports by the Coalition for Few or virtually no people who inject Global Hepatitis Elimination focus on the 20 drugs have been treated in the countries with the highest HCV burdens. That majority of countries. According to is, if these 20 countries meet the WHO targets by 2030, HCV could effectively be eliminated. the mapCrowd database, less than However, other than Europe, most regions did 2% of people who inject drugs have not see a major decline in HCV-related mortal- been treated even in countries where ity in the years 2015–2019.7 The progress reports elimination plans have been launched. highlight the expansion of generic treatment access, mostly in low- and middle-income coun- The availability of the cure in countries has little tries. However, other than in Europe, the majority impact if harm reduction coverage is lacking and of countries do not have more than one needle the people who are most in need and dispropor- and syringe program (NSP).8 tionately affected by hepatitis C do not access 3 TREATMENT ACTION GROUP POLICY BRIEF treatment and care.9 Few or virtually no people We need to treat 5 million people every who inject drugs have been treated in the ma- year worldwide to achieve hepatitis C jority of countries. According to the mapCrowd database, less than 2% of people who inject drugs elimination by 2030 have been treated,10 even in countries where and sobriety—in more than half of U.S. states,13,14 elimination plans have been launched. the U.S. is failing in its HCV response and will We need to treat 5 million people every year miss the 2030 WHO global targets (see Figure 15 worldwide to achieve hepatitis C elimination by 2). Recent modeling shows only three states (6%; Connecticut, South Carolina, and Wash- 2030.11 ington) are on track to reduce new HCV cases In the U.S., we need to treat an estimated by 80%, and only 16 states (31%) are on track 16 173,514 people each year to reach the 2030 to treat 80% of patients with HCV by 2030. treatment target.12 Some progress has been made, however, with 45 states (87%) expected to diagnose 90% of their Despite lifting insurance barriers and treatment HCV infections and 46 states (88%) on track to restrictions—including levels of liver scarring reduce HCV-related mortality by 65% by 2030. Figure 2. Year of Elimination17 WA ME MT ND VT OR MN NH ID WI NY MA SD RI WY MI CT IA PA NE NV OH NJ IL IN DE UT MD CA CO WV VA DC KS MO KY YEAR: NC < 2030 AZ OK TN 2031-2035 NM AR SC 2036-2040 AL MS GA 2041-2049 > 2050 TX LA AK FL HI PR *The estimation may be less accurate owing to the small number of patients with HCV in the area. Increasing treatment initiation requires increasing HEALTH NEEDS FOR PEOPLE WITH the number of people who are tested and diag- HCV IN THE COVID-19 ERA nosed with HCV. An estimated 80% of people living with HCV remain undiagnosed worldwide People who recover from COVID-19 have been and, of those, more than 95% live in low- and mid- shown to have elevated liver enzymes;20 people liv- dle-income countries.18 COVID-19 has derailed ef- ing with viral hepatitis, liver scarring, liver disease, forts to screen, newly diagnose, and start people or other hepatic conditions will need to monitor on treatment. Modeling estimates19 of the global their liver function following their recovery from impact of COVID-19 predict that a one-year gap coronavirus. It is unclear if people with viral hepa- and delay in HCV services will result in 44,800 titis have worse health outcomes from COVID-19, additional cases of liver cancer and 72,300 addi- however, preliminary studies21 show that COVID-19 tional liver-related deaths, mostly in high-income has higher mortality rates for people with chronic countries, between 2020 and 2030. liver disease and cirrhosis: 63.2% of people with 4 TREATMENT ACTION GROUP POLICY BRIEF new decompensated liver disease died from CO- HCV PROGRAMMATIC IMPACTS VID-19 compared to 26.2% who did not have new OF COVID-19 decompensated liver disease. The pandemic has paused global hepatitis C test- Protecting lung health, in addition to liver health, ing and treatment and disrupted healthcare and is important for people living with HCV, particu- harm reduction services, including needle and sy- larly people who formerly or currently vape or ringe programs (NSP) and provision of opioid sub- smoke tobacco or cannabis or inject or use other stitution therapy (OST). The results of a 32-country substances. Taking opioids slows breathing, de- survey25 conducted by the World Hepatitis Alliance creases oxygen in the blood, and can decrease between March 30 and May 4, 2020 further dem- lung capacity. Methamphetamine use can tighten onstrate the severe impacts on global hepatitis blood vessels and contributes to pulmonary dam- programs: 94% (121 of 132 total respondents; 50% age and hypertension.22 Financing and sustaining from the U.S.) responded that their viral hepatitis peer-driven harm reduction and counseling ser- services were affected by COVID-19. Lack of test- vices can assist with strategies to better protect ing was reported by 66 (or 65%) of 101 respon- dents; this was attributed to avoiding healthcare lung and liver health.