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Experts Tackle Misunderstandings About Hep C Treatment

In 2016, Maia Hughes decided to begin recovery after 13 years of substance abuse. But it wasn't only substance use disorder she needed to address. She had also tested positive for hepatitis C, a virus that spreads through blood.

"I know some people that use drugs [intravenously] that are very careful — only use clean syringes, new supplies," Hughes says. "I didn't. I was so far into my addiction that I didn't really care. If I was sick, it didn't matter. I would use whatever syringe because I didn't want to be sick." She believes she knows the occasion when she contracted the virus.

Hughes waited until two years into her recovery to start treatment for the virus. "I already felt enough guilt and shame around using and still struggling with a lot of self-worth and embarrassment from 13 years of all that I had done," she explains. "So having hep C just kind of tacked on to that [was hard]."

Hughes participated in the Buncombe County Sobriety/DWI Treatment Court and then started HCV treatment in 2018 because she "figured it was the responsible thing to do to make sure I was in the clear."

After two months of taking a pill, Harvoni, daily, she had cleared the virus from her body. "It was a supersimple process," she recalls.

Hughes is now cured.

Better treatments

HCV primarily infects the liver. Symptoms, such as jaundice, sometimes don't show for years or even decades — after which point, the liver is already damaged. (Hughes didn't experience any symptoms.) When HCV becomes a chronic infection, it can cause liver inflammation, cirrhosis (scar tissue developing on the liver), an increased risk of developing liver cancer and liver failure, leading to death. A vaccine for the virus doesn't exist.

HCV can be transmitted through infected blood from a mother to her baby, or via tattoos or piercings with unsterilized equipment, blood transfusions or sharing syringes for injectable drugs.

As HCV is an infectious disease linked to the opioid crisis, a patient's current drug use can lead to stigma in health care settings, says Raymond Velazquez, director of prevention services at Western North Carolina AIDS Project. "A lot of providers in this area will not treat people for hep C while they're using drugs," he says. "It's very important to treat the virus in this case — versus the person's drug use — because that's not why they're there."

WNCAP sends patients with HCV to providers who are capable of "respecting the individual as they are," he explains, such as Dale Fell Health Center, the Asheville location of Appalachian Mountain Community Health Centers. These are federally qualified health centers that serve patients regardless of their ability to pay.

It's a misunderstanding that individuals experiencing addiction cannot begin treatment for HCV unless they're in recovery. In 2020, North Carolina Medicaid lifted requirements that individuals getting treatment for HCV must engage in treatment programs if they have a history of alcohol abuse or abstain from high-risk behavior. CareReach HCV bridge counselor Christine Sipe says she's had clients who "seem to believe that you can't do the treatment if you're still drinking or if you're still using, and that's not true."

CareReach is a nonprofit helping individuals navigate medical care, including HCV care in Buncombe County; clients are referred through the Buncombe County Department of Health and Human Services.

Another misconception is that current treatment for HCV causes unbearable side effects. Velazquez acknowledges that previous treatments "made individuals feel very sick … [it] was very hard on the body." According to Healthline, the first treatment for HCV, called IFNa, debuted in the 1980s and led to side effects including nausea, vomiting, hair loss, depression and suicidal thoughts. A more effective treatment, RBV, arrived in the 1990s, but side effects included thyroid issues, anemia and psychosis.

The current treatments are direct-acting antivirals, and according to Healthline, they have moderate side effects, like fatigue. Velazquez says he encounters people through WNCAP's harm reduction program who believe harsh medications are the only way to cure HCV. And Hughes believed that herself. "I thought it was going to be this whole big ordeal," she says. "And it wasn't at all."

According to the Centers for Disease Control and Prevention's Division of Viral Hepatitis, HCV is curable in over 95% of cases.

Cost of treatment

According to a 2022 report on viral hepatitis in North Carolina from the N.C. Department of Health and Human Services, the state "observed a marked increase in acute hepatitis C cases" beginning in 2009. As of 2020, North Carolina had 72,552 individuals with chronic HCV. In 2016, Buncombe County was identified as one of the "vulnerable counties" for the virus and was permitted to send HCV screenings for uninsured individuals to the state Laboratory of Public Health. Currently, all local health departments are allowed to do so.

Data indicated "some real alarming upticks in the amount of hep C-positive individuals in the state, in particular in WNC," says CareReach Executive Director Joseph Jones. Recognizing that treatment navigation could be a barrier, in 2018, the N.C. Viral Hepatitis Program created a bridge counselor program. Buncombe welcomed a bridge counselor through CareReach that same year.

Most individuals come to CareReach already aware of their HCV diagnosis, says Sipe. But people who haven't been tested, and are being served by CareReach for another reason, are connected to local testing locations like Planned Parenthood South Atlantic Asheville Health Center, Mountain Area Health Education Center, Western North Carolina Community Health Services Minnie Jones Clinic and WNCAP. Often testing for HIV, another blood-borne virus, is also available.

Lab work gathers more information about the individual's genotype (the genetic makeup of their blood) and their viral load. Individuals generally also receive eight-12 weeks' worth of the daily medication, which is tailored to their genotype.

Paying for treatment is a concern for some clients. Jones wants prospective clients to know that "lack of insurance shouldn't be a barrier" to treatment and notes that "the vast majority" of his nonprofit's clients are uninsured. Many of their referrals come through Homeward Bound or Julian F. Keith Alcohol and Drug Treatment Center. Sipe can connect individuals to patient assistance programs at MAHEC and Blue Ridge Health, another federally qualified health center, which "will all treat for no or low cost," Jones says. Hughes says the costliest part of the process was a liver scan she had to undergo at a gastroenterologist prior to beginning treatment. She was able to pay in installments.

'Relief'

Hughes says the relief she felt after learning she was cured of the virus was "huge."

She continues, "I don't have to worry about [HCV] anymore or worry about it progressively getting worse and causing more significant damage in the future."

Now Hughes focuses on her career, maintaining her recovery and sharing her story at Narcotics Anonymous meetings. She is a certified peer support specialist with Sunrise Community for Recovery and Wellness, a community recovery organization, and she was previously the medication-assisted treatment coordinator at the Buncombe County Detention Center. Last year, alongside MAT services director Sarah Gayton, she received a 2022 Dogwood Award, which is awarded by the Buncombe County Board of Commissioners to individuals who help make their communities safer.

UPDATE, MAY 25: This article has been updated with the correct spelling of Christine Sipe's name. 

Chelsea Clinton: How To Eliminate Viral Hepatitis By 2030

Viral hepatitis affects almost 400 million people and kills more than 1 million each year.

Yet it was left off the agenda of the Millennium Development Goals. Now, 20 years later, we have a cure for hepatitis C and a highly effective vaccine and treatment for hepatitis B — but annual deaths from the two are projected to outnumber deaths from HIV, tuberculosis, and malaria combined by 2040. As is also the case with HIV, tuberculosis, and malaria, the vast majority of people with viral hepatitis live in low- and middle-income countries in sub-Saharan Africa, Asia, and the Eastern Mediterranean.

The World Health Organization estimates that almost 90% of people living with hepatitis are unaware that they have it. The testing rates for hepatitis C recall the early years of the HIV epidemic.

But it doesn't have to be this way.

Since 2016, all World Health Organization member states have committed to eliminate viral hepatitis by 2030, as part of the U.N. Sustainable Development Goals.

This goal is achievable. Countries including Egypt, Rwanda, Georgia, and Mongolia are well on the way to eliminating viral hepatitis. The U.S. Is striving to meet this goal, too; President Biden recently called for $5 billion to eliminate hepatitis C in the U.S. By 2030.

There are comparatively inexpensive, high-quality generic drugs to cure hepatitis C and treat hepatitis B that prevent liver disease — including liver cancer and cirrhosis — and death. There are tools to prevent new infections, including a cheap and effective vaccine for hepatitis B; a vaccine and antiviral prophylaxis for pregnant women to prevent hepatitis B transmission; and harm reduction interventions to prevent hepatitis C among people who use intravenous drugs.

Aside from the public health benefits, eliminating hepatitis also makes good economic sense. According to a recent global model, investment in hepatitis C would generate $46 billion in cumulative productivity gains and become cost-saving by 2027, with a net economic benefit of $22 billion by 2030.

The lack of progress in the response to viral hepatitis comes down to a lack of financial investment by donors and countries.

One hundred and twenty-four countries have developed plans to eliminate viral hepatitis, but without funding, it's impossible to get those plans off the ground, let alone scale them.

There are some promising signs that support may be increasing. Under its 2023-2028 strategy, the Global Fund to Fight AIDS, TB, and Malaria has recognized the importance of addressing HIV co-infections and has committed to funding viral hepatitis prevention, diagnosis, and treatment alongside its efforts to end AIDS and improve health outcomes for people living with HIV and at risk of HIV infection.

Unitaid has made strategic investments to help shape markets for the introduction of hepatitis C diagnosis and treatment resources, and to support innovative methods of harm reduction among populations that have a higher risk of hepatitis C infection, including people who are incarcerated and people who inject drugs.

Under its 2021-2025 Vaccine Investment Strategy, GAVI, the Vaccine Alliance, formally approved support for the introduction of a hepatitis B birth dose vaccine in 38 eligible countries, estimating that this could avert up to 1 million infection-related deaths and 1.5 million new cases in newborns between 2021 and 2035. Unfortunately, the Covid-19 pandemic has led to a delay in the rollout of these investments; Gavi's board will make a decision about the future of these investments in June.

The U.K. Foreign, Commonwealth and Development Office has also made investments to support efforts to reduce the cost of hepatitis drugs and diagnostics, and direct funding toward expanding access to testing, treatment and prevention.

Despite these efforts, eliminating hepatitis B and C by 2030 will be impossible if donor investments don't increase.

And we aren't just talking about billion-dollar investments. Small-scale investments — as little as $250,000 per country annually — in local organizations working on hepatitis elimination can galvanize governments to make the additional domestic investments necessary to put their countries on the path to elimination.

Our organizations — the Hepatitis Fund and the Clinton Health Access Initiative — have partnered to fund and deliver these kinds of catalytic interventions, and in a very small space of time they have yielded admirable results on the ground.

During the Covid-19 pandemic, the Hepatitis Fund issued first-round grants to organizations to scale up hepatitis programs in Pakistan, Vietnam, and Zambia. Those investments have created demonstrable change in lower out-of-pockets costs for individuals, increased human resources capacity to bring care closer to those in need, and helped governments unlock domestic resources for hepatitis elimination by supporting national strategic planning and investment cases.

For instance, in Vietnam, the government now reimburses hepatitis C confirmatory testing outside of hospitalization. In Pakistan, 461 primary care centers are now offering hepatitis C screening.

Egypt and Rwanda have also had success when it comes to reducing their viral hepatitis burdens.

Egypt once had the highest rate of hepatitis C in the world, and one in 10 people were living with viral hepatitis. But since 2014, the country has made huge progress toward eliminating the disease through a partnership approach that engaged civil society, the private sector, and philanthropic organizations to mobilize the community and increase rates of screening, diagnosis, and treatment.

Step one of its strategy was to get the buy-in of various government ministries, including and beyond the health ministries. The second was to integrate hepatitis C screening with noncommunicable disease screening in primary health care facilities. This approach reached some 60 million people, including 9 million schoolchildren.

Since implementing this strategy in 2014, the prevalence of hepatitis C in Egypt has dropped from just over 6% to 2%.

Likewise, Rwanda has historically battled significant levels of hepatitis B and C infections. When the viral hepatitis program started in 2011 an estimated 4% of the population were living with hepatitis C, while hepatitis B prevalence was around 2%, with the scale of infection higher among vulnerable populations, including individuals living with HIV. The 1994 genocide that claimed more than 1 million lives is also thought to have led to widespread hepatitis transmission due to mass casualties and injuries.

As part of rebuilding its health system guided by a policy implemented in February 1995, Rwanda increased activities around tackling its hepatitis epidemic. Catalytic Global Fund investments allowed the country to integrate a viral hepatitis control program into its robust HIV program. This momentum led to a political commitment by Rwanda in 2018 to eliminate hepatitis C ahead of the 2030 elimination target date and enabled the country to negotiate the lowest-ever price for WHO pre-qualified direct-acting antivirals, $60 per person, to cure hepatitis C. This program has contributed to the screening of more than 6 million Rwandans and treatment of more than 60,000 patients to date.

Now, as announced at Wednesday's inaugural Hepatitis Resource Mobilization Conference in Geneva, that same price will be available to low- and middle-income countries, as the Clinton Health Access Initiative and the Hepatitis Fund have signed access agreements with several generic manufacturers that will lower the cost of treatment by over 90%.

The global impact of the Hepatitis Fund's catalytic and targeted interventions tells a similar story: 580 health workers have been trained by its grantees, and more than 200,000 clients have been screened for hepatitis B and C with 15% positively diagnosed and around 60% of those diagnosed receiving treatment. And those numbers have been achieved in a tight and challenging time frame marked by the beginning of the Covid-19 pandemic through to today.

This approach could be the blueprint the world needs for reaching the goal of eliminating viral hepatitis by 2030 — if implemented on a wider scale with donor support, the right technical assistance, and strategic deployment of resources on the ground. What are we waiting for?

Chelsea Clinton is vice-chair of the Clinton Foundation and the Clinton Health Access Initiative. Finn Jarle Rode is executive director at the Hepatitis Fund. The Clinton Health Access Initiative and The Hepatitis Fund are hosting the inaugural Global Hepatitis Resource Mobilization Conference in Geneva, Switzerland, this week.

Gilead Remains Steadfast In Support For Hepatitis C Elimination Efforts

FOSTER CITY, CA / ACCESSWIRE / May 3, 2023 / The recent national conversation on hepatitis C (HCV) is an encouraging step towards viral hepatitis elimination in the U.S. With its long history of leadership in viral hepatitis, Gilead continues to support efforts that focus on HCV elimination. Gilead is proud that its medicines have treated over four million individuals living with HCV globally. Today, some 2.4 million people are living with HCV in the U.S., even though ~95% of those treated with direct-acting antivirals (DAAs) are cured. Prices of HCV medicines have dropped significantly, and many acknowledge that price is not a barrier for most payers and patients. Curative HCV drug therapies are just one part of an elimination strategy that needs to dedicate considerable resources and attention to screening and linkage to care so that all patients in need of HCV treatment can access it in a timely manner and achieve a cure.

Gilead believes that to make meaningful progress toward HCV elimination, the following three efforts are critical to success:

1. Additional public health resources that support screening and linking patients to care. A comprehensive HCV elimination strategy must include dedicated efforts to educate new providers in the treatment of HCV, greater community awareness, as well as better integration between diagnosis, treatment, and support services. Better point-of-care tests, robust disease monitoring, and surveillance are also needed. Without all these elements, the U.S. Will not be able to achieve its HCV elimination goals.

2. Ensuring patients can access a treatment that works for them and allows them to achieve a cure. The patient-provider relationship should drive treatment decisions to ensure that the regimen minimizes side effects, supports patient adherence, and ultimately achieves sustained virological response (SVR). Open access is also critical to reducing health-related inequities often experienced by individuals living with HCV, including the need to appeal for coverage of an excluded medicine. In the absence of an effective HCV vaccine, current HCV treatment regimens represent the most effective means to prevent disease transmission. A national procurement for HCV treatment that limits treatment choices is therefore not the solution for the needs of specific populations that have not yet been able to achieve HCV elimination.

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3. Removing all restrictions on who can receive treatment. Payers, including some state Medicaid programs, still maintain restrictions to curative care such as sobriety requirements, regulations on who can treat patients living with HCV, and unnecessary tests1 that do not inform treatment decisions for most patients. These barriers are not supported by medical guidance and national recommendations for managing the care of high-risk individuals2. In some cases, such as incarcerated individuals, HCV screening, linkage to care, and treatment are either limited or absent. Healthcare providers need all the tools available to adequately address and support a patient's health needs upon diagnosis, and restrictions to treatment options can have unintended negative consequences for the vulnerable patients they serve.

Gilead appreciates and supports a wide range of collaborative initiatives intended to eliminate HCV in the U.S. And welcomes the continued dialogue on a multipronged approach to meaningfully impact HCV elimination in the U.S.

About Gilead SciencesGilead Sciences, Inc. Is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

For more information about Gilead, please visit the company's website at www.Gilead.Com, follow Gilead on Twitter (@Gilead Sciences), or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

1 i.E. Fibrosis score measurements2https://www.Hcvguidelines.Org/unique-populations/pwid

Originally published by Gilead Sciences

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SOURCE: Gilead Sciences

View source version on accesswire.Com:https://www.Accesswire.Com/752679/Gilead-Remains-Steadfast-in-Support-for-Hepatitis-C-Elimination-Efforts

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