Tag Archives: Direct Acting Agents

Hepatitis C Therapies Added to WHO Essential Medicines List

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Since 1977, the World Health Organization (WHO) has published its Essential Medicines List containing the medications considered to be the most effective and safe to meet the important needs in a health system. This year, the organization has included the following Hepatitis C (HCV) Direct Acting Agents (DAAs) Sovaldi (Gilead), Olysio (Janssen), Harvoni (Gilead), Viekira/Viekira XR (AbbVie), Daklinza (Bristol-Myers Squibb), Technivie (AbbVie), and Epclusa (Gilead) (WHO, 2017). Notably absent from this list is Zepatier (Merck) – to date, the lowest priced HCV DAA with a Wholesale Acquisition Cost (WAC) of $54,600.

World Health Organization logo

Since the 2013 launch of Sovaldi and Olysio, new drugs to treat HCV have entered the market at a relatively rapid pace, from just two drugs in 2013, to nine drugs by 2016. That said, two or more new drugs hit the market in 2017:

AbbVie’s new next generation protease inhibitor & NS5A inhibitor known as G/P or GLECAPREVIR/PIBRENTASVIR; Gilead’s new triple [combination] of Sofosbuvir + Velpatasvir + Voxilaprevir which contains their new protease inhibitor (Vox.); [Merck’s new triple combination] (Uprifosbuvir) + Grazoprevir + Rusasvir; [Janssen’s] new triple AL-335 + Odalasvir + Simeprevir (Levin, 2017).

With so many treatment expensive options available to treat HCV, as well as the availability of reasonably priced generics in lower-income countries, there is little doubt that these medicinal cures for HCV should be included in every nation’s list of essential drugs. Furthermore, research shows that the generic versions of Sovaldi, Daklinza, and Rebetol (Ribavirin) are as effective as their brand name counterparts (Preidt, 2016).

Some concerns exist, however, that the high cost of treating HCV in nations who are forced to pay the high price for brand name drugs will prevent these cures from reaching the patients most in need. The Centers for Disease Control and Prevention (CDC) recently released a report detailing how restrictive state Medicaid policies – as well as state restrictions regard Syringe Exchange Services/Programs (SESs/SEPs) – are contributing to the vast increase in new HCV infections (CDC, 2017). Most states’ Medicaid programs require Prior Authorization (PA) standards for HCV drugs that are stricter than for most cancer-related treatments, in no small part because those prerequisites serve as cost containment tools – the more complicated and cumbersome the requirements, the less likely the program is to have to cover the cost of treatment.

While the inclusion of HCV DAAs to the WHO Essential Medicines List is an important step forward toward nations including them on their own lists, the high cost of the medications may prove prohibitive to some nations doing so. As the battle over “what the market will bear” soldiers on, HEAL Blog will continue to monitor the situation.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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U.S. Department of Veterans Affairs Requests Increase in HCV Funding

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Cover of the FY 2018 Budget Submission

Source: U.S. Department of Veterans Affairs

The United States Department of Veterans Affairs (VA) has laid out plans to continue their open treatment policy for eligible veterans living with Hepatitis C (HCV) into 2019 and beyond. The budget request sent to Congress – Fiscal Year (FY) 2018 and FY 2019 Advance Appropriations – highlights some of the successes the program has achieved in delivering comprehensive HCV treatment using Direct Acting Agents (DAAs) to cure HCV, as well as puts forth a request for an additional $751 million in funding specifically for HCV treatment. This is a $151.2 million increase from the 2018 Advance Appropriations requested in the previous year’s document.

The VA began offering treatment to all veterans in its health system regardless of their disease stage in March 2016 (Kime, 2016), a major step forward for the program, as the high cost of newer DAA drugs have proven prohibitive to decisively moving to eradicate HCV within other government healthcare programs enrollees. This also allowed veterans who were “…waiting on an appointment for community care through the Choice program [to] turn to their local VA facility for this treatment or elect to continue to receive treatment through Choice.” The Veterans Choice Program – introduced in 2015 – is a temporary benefit that allows veterans who were enrolled in VA health care prior to August 01, 2014, or who are eligible to enroll as a recently discharged combat veteran, to receive care in their communities, rather than waiting for a VA appointment or traveling to a VA facility (Peterson, 2015).

In the document recently sent to Congress, the VA also touted some of the successes of the program:

  • As of December 2016, 78.8% of Veterans in care in the 1945-1965 Birth Cohort – those most likely to have HCV in the U.S. – were screened for HCV, and the VA estimates that an additional 15,500 veterans in VA care remain undiagnosed.
  • From January 2014 through March 2017, the VA has treated over 84,000 veterans with cure rates over 90%.
  • As of February 2017, 61,000 veterans diagnosed with HCV were potentially eligible for treatment.
  • The VA estimates that approximately 80% of all veterans with HCV enrolled in VA care will be treated by 2020. Veterans remaining in the untreated pool at that time are estimated to be more difficult to engage in care due to issues like homelessness, mental health, and substance use comorbidities, or may be uninterested or unwilling to receive HCV treatment.
  • The number of total national HCV treatments increased from approximately 2,800/year in 2011-2013, to over 30,000 in 2016. This growth reflects the additional demand for HCV treatment with DAAs, beginning the second quarter of 2014 through the present.

The VA’s approach to treating veterans is a success story that CAN be repeated by other government-run healthcare programs, but doing so will require state and Federal governments to exponentially increase funding in order to eradicate HCV within the populations most likely to become infected. The Centers for Disease Control and Prevention (CDC) estimates that the vast majority of new HCV infections is a result of Injection Drug Use (IDU) among rural and suburban white men and women aged 18-35 (Dwyer, 2017). The populations are likely to also have lower incomes that may make them eligible for coverage under state Medicaid programs (in Medicaid Expansion states).

The full VA Budget Request can be viewed at the following link:

Department of Veterans Affairs – FY 2018 and FY 2019 Advance Appropriations

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Pennsylvania Medicaid Opens HCV Treatment to Virtually All HCV Patients

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

On May 16th, 2017, Pennsylvania’s Department of Human Services (DHS) announced changes to the state’s Medicaid policy that will expand coverage to treat virtually all enrolled clients living with Hepatitis C (HCV). Beginning July 1st, 2017, HCV-infected beneficiaries with liver scoring of F1 will become eligible for treatment coverage for the newer Direct Acting Agents (DAAs) that are highly effective, easily tolerate, and also very expensive. Beginning January 1st, 2018, clients with liver scoring of F0 will become eligible for treatment coverage. Prior to the July 1st policy change, treatment coverage will be available only to clients whose liver scoring ranges F2 to F4, unless other mitigating complications exist that warrant immediate treatment.

These changes come in response to a number of factors, most notably the 290% increase in new HCV infections between 2014 and 2015 reported by the CDC earlier this month. The deciding factor in this case, as in many other state Medicaid decisions, was the threat of a class action lawsuit. Attorneys from the Center for Health Law & Policy Innovation at Harvard Law School, the Pennsylvania Health Law Project, Community Legal Services, and Kairys, Rudovsky, Messing, & Feinberg, LLC sent a formal demand letter in late 2016 on behalf of their clients, Pennsylvania Medicaid recipients. This letter notified DHS that unless it agreed to remove “categorical coverage exclusions” of HCV medical cures from its Medicaid policy, the state could face a Federal class action law suit (Harvard Law School, 2017).

For the uninitiated, a little explanation is likely in order on the topic of “F scoring.” The “F” stands for fibrosis – the thickening and scarring of connective tissue, usually the result of injury. In relation to the liver, F scoring describes the length in expansion of fibrotic areas between portal tracts (also known as “portal triads”), and these changes are staged at F0 (No fibrosis) to F4 (Cirrhosis) (Hepatitis C Online, 2015). Patients with F4 Cirrhosis is characterized by a loss of liver cells and irreversible scarring of the liver. A healthy liver regulates the composition of blood, including the amounts of sugar (glucose), protein, and fat that enter the bloodstream. It also removes bilirubin, ammonia, and other toxins from the blood (WebMD, n.d.). A cirrhotic liver cannot properly perform these functions, leaving the patient susceptible to numerous painful and life threatening illnesses and side effects of failing or failed liver function.

The changes to Pennsylvania’s Medicaid program make it one of the first in the nation to adequately address the burgeoning HCV epidemic by treating patients early in the disease cycle. While the newer DAA drugs are all very expensive, the cost of curing patients outright, rather than continuing to pay for their long-term health degradation while waiting for their liver to become scarred enough to treat their HCV. Aside from being costly, it is also inhumane. While HIV patients underwent similar treatment in relation to the recommendation of when they begin Antiretroviral Therapies (ARTs), eventually we came to the realization that treating the disease early would result in fewer long-term complications for HIV patients. This way of thinking in terms of HCV patients is likelier to come more quickly, now that we have medically curative treatments.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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HCV Prescribing Lags While Prices Soar

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

An article in Newsweek in March 2017 talked about a “…crowded and confusing” landscape for treating Hepatitis C (HCV) that prevents many Primary Care Physicians (PCPs) from prescribing the new Direct Acting Agents (DAAs) to treat the disease (Wapner 2017). The argument posed is that, physicians are “…still too unfamiliar with the regimens to speak with confidence about them,” according to Ira Jacobson, a hepatologist who leads the department of medicine at Mount Sinai Beth Israel Hospital in New York. He posits that this discomfort leads them to send patients to liver specialists, or to delay treatment until more severe symptoms arise, the latter of which is a regular pre-requisite on virtually every Prior Authorization (PA) request form.

This argument caught my eye, as someone who writes about and researches coverage for these DAA drugs, as has done so since 2013. One of the most frequent conversations I heard when Sovaldi (Gilead) and Olysio (Janssen) were first released on the market was that there was confusion over which doctors could prescribe them. Unlike HIV, treatments for HCV largely lagged in the ‘completely intolerable’ realm, with patients dropping out of treatment like flies and a success rate of only around 50%. Things, however, have radically changed; the question, then, becomes, “Have doctors?”

Prescription Pad

Realistically, we have a considerable problem, in the United States, with aspiring doctors choosing to specialize, rather than going into general practice, in no small part because it guarantees them higher incomes. Higher incomes for them, however, means higher costs to consumers, in the same way that higher-priced drugs to treat chronic conditions get shunted into the highest pricing tiers. This gets passed along to consumers in the form of higher co-pays for visits ($25 for PCPs; $75 for Specialists), and higher co-pays for medications ($3 for blood pressure medication; $250 for HIV).

This problem extends, also, to prisons and jails – the high cost of treatment serves as a significant barrier to providing inmates with treatment, which presents a larger issue, because inmates have an exponentially higher incidence and prevalence of HCV than the general population (Gloucester Times, 2017). Testing prisoners is expensive, as well, as inmate populations swell, while prison healthcare budgets remain relatively stagnant. Once those prisoners are released back into the general population, if they’re unaware of being infected with HCV or whose infections have gone untreated, they can go on to infect those who are not part of the prison system, are also unlikely to be tested and treated.

Beyond just the cost of co-pays are the long-term costs of PCPs being reticent to screen or prescribe for HCV: failing to address HCV will lead to liver decompensation, liver cancer, kidney diseases and failure, higher HCV viral loads that make spreading the disease easier, jaundice, digestive illnesses, and thyroid issues, none of which are particularly cheap to treat. The host of accompanying side effects of leaving the disease untreated far outweigh the admittedly outlandish prices set by HCV drug manufacturers.

The reality is that any medical doctor who has prescribing privileges can prescribe these new treatment regimens. The vast majority of these doctors also have access to smartphones, all of which have any number of apps designed to compare new drug regimens with existing prescriptions to ferret out counter-indications; there is, in fact, an entire website specifically aimed at finding counter-indications (http://www.hep-druginteractions.org/) that also offers mobile apps. The argument that doctors are unsure of the counter-indications is really rendered moot by the existence of these easy-to-use tools.

With that, the biggest hurdle to overcome, for virtually every party involved, is the cost of treatment, and with the current administration’s funding priorities being…questionable, at best…it’s unapparent if even the existing treatment coverage landscape will exist. We’re hoping for more stable conditions, and less erratic proposals. Until then, we’ll just keep plugging to try and find a solution.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Hepatitis C and Medicare Part D

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

HEAL Blog has consistently covered the cost of new Direct Acting Agents (DAA) used to treat Hepatitis C (HCV), as well as the impact those prices have had on state Medicaid and AIDS Drug Assistance Programs (ADAPs). What we haven’t really covered is how those costs have impacted Medicare and the Medicare Part D program.

In addition to writing for HEAL Blog, I also serve as the Project Director for the HIV/HCV Co-Infection Watch. Last year, we looked into expanding our reporting of HCV drug coverage to include Medicare Part D markets, and what we found was that it was simply too much data to fit into an already then-76-page report. In June, I went ahead and looked at coverage for the Part D Standalone drug plans, and wound up scouring 923 different plans across the country and in five territories. What I discovered was that 922 plans covered the two most expensive HCV drugs on the market at that time – Sovaldi and Harvoni (Gilead).

That translates into staggering figures for Medicare Part D expenditures, as outline in reports from the Centers for Medicare and Medicaid Services (CMS). In 2014, spending on the three most-prescribed HCV drugs – Sovaldi, Harvoni, and Olysio (Janssen) – totaled $4.665 billion (CMS, 2016). Preliminary data obtained by the Associated Press (AP) from CMS estimate that the cost of HCV drugs to Medicare in 2015 nearly doubled, coming in at roughly $9.2 billion (Alonso-Zaldivar, 2015). This figure comes despite the introduction in 2015 of HCV therapies with lower Wholesale Acquisition Costs (WACs) than the $87,000 Sovaldi or $94,500 Harvoni.

Since the introduction of Sovaldi and Olysio in 2013, HCV drugs have consistently ranked in the top ten drug expenditures for Medicare Part D, as they have for Medicaid and the Veterans Administration (VA). The primary difference is that both Medicaid and the VA pay lower prices for the drugs as a result of state Medicaid negotiating power and the VA’s “Best-Price” rule that requires pharmaceutical companies to provide drugs at the lowest possible price. Medicare, however, is prohibited from negotiating drug prices as a result of the Medicaid Modernization Act (2003) that established Medicare Part D. One of the main provisions of the Act states that, “…in order to promote competition,” the Health and Human Services (HHS) Secretary “…may not interfere with the negotiations between drug manufacturers and pharmacies and prescription drug plans.”

President Donald J. Trump

Photo Source: UPI

Democrats have long attempted to pass legislation that would amend this provision, and may have found a new, not-so-secret weapon – President Donald Trump (Tribble, 2017). He has repeatedly stated that he believes Medicare should have this power, much to the consternation of Tom Price, Trump’s own Secretary of Health and Human Services, and Republicans, who have long held that Medicare negotiating drug prices amounts to Federal tyranny, Big Government, and anti-“Free Market” practices. But, even those Republicans are balking at the high cost of HCV drugs.

HEAL Blog will continue to watch in the coming months how this situation plays out, but we can be certain that, like every Trump initiative, the path will be fraught with confusion, disarray, and uncertainty.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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An Imperfect Prison Health System

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

One of the primary issues for people in America’s vast prison system is the issue of healthcare rights and treatment. In fact, prisoners are the only Americans who are Constitutionally guaranteed the right to treatment for health conditions under the 8th Amendment, specifically the “cruel and unusual punishments” clause (Estelle v. Gamble, 1976). This ruling has been used since 1976 to ensure that inmates who are infected with HIV, and now, Hepatitis C (HCV), receive the appropriate medical treatment to which they are guaranteed under that decision. Additional arguments can be made that using a “Treatment as Prevention” (TAP) model in incarceration settings will help to stem the spread of various Sexually Transmitted Diseases (STDs) and Infection (STIs), including both HIV and HCV.

Over the past two years, HEAL Blog has covered various aspects of the HCV treatment provision for inmates in various states. Several states, including Tennessee, Nevada, Missouri, Washington state, and Pennsylvania, are currently facing lawsuits brought my inmates and advocates in state and Federal courts to force their respective Departments of Corrections to provide treatment to HCV-infected patients. Unfortunately for the states – and more specifically, their budgets – courts have seemed inclined to agree with both advocates and inmates: providing treatment and a cure for HCV is mandatory, regardless of the expense.

Nurse administer care to an inmate.

Photo Source: Prison Protest

The primary argument used by states and their respective Departments of Corrections is that the high cost-per-patient/per-cure is simply an unreasonable expenditure, given the long-term nature of the disease (meaning the length of time from gestation to serious illness to death). The cheapest Wholesale Acquisition Cost (WAC) of the newer Direct Acting Agents (DAAs) to treat HCV – Zepatier (Merck) – is $54,600 for twelve weeks of treatment, before any discounts, rebates, or pricing agreements struck between states and the drug manufacturers. Viekira XR (AbbVie) and Epclusa (Gilead) cost $83,319 and $74,760, respectively, which makes treating inmates with HCV incredibly expensive in one go.

Gilead and other manufacturers have argued – with only moderate success – that the short-term high cost of a cure actually ends up costing less in the long-term, when compared to both the co-infections and –morbidities (co-existing conditions) that can accompany untreated HCV infections, and the long-term cost of treating other serious chronic illnesses, which over a course of several years, account for far more money being spent to treat them. While this argument may look great on paper for the manufacturers, for government employees and elected representatives who are tasked with prepared, appropriating, and allocating funds in a budgeting process, it’s simply not a feasible one. By their way of thinking, long-term illnesses represent costs that can be spread out over time, while HCV manufacturers expect a cure, right up front, set at a budget-breaking price.

States have found a unique way of getting around the 8th Amendment statute that courts have ruled guarantees treatment: they simply fail or refuse to screen incoming and existing inmates. Many states require that inmates only be screened for HIV during the intake process, allowing prison officials to essentially feign ignorance about their prisoners’ health – if they don’t know, they don’t have to treat. Unfortunately for the state, prisoners are getting wise to this tactic, and are taking them to court to force treatment. Nevada, for example, reported 593 inmates with HCV, including just two who were receiving treatment (0.34%) in 2015 (Botkin, 2017). By March 2016, a total of only nine inmates were receiving treatment.

Given the vast budget constraints placed upon states, we at HEAL Blog understand that the cost of treating every HCV-infected inmate is a potentially financially disastrous proposal, and a non-starter in virtually every state. Attempting to get around those costs by ignoring the problem is simply an unacceptable way for state and Federal prisons to operate. Yes – treatments are expensive; but, when lives are at stake, trying to get around a Constitutional obligation to treat is simply unacceptable.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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HIV and Hepatitis C Counterindication Conundrum

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

In two separate posts in 2016, HEAL Blog covered the complex world of treating Hepatitis C (HCV) infections in people co-infected with HIV. While both HIV and HCV treatment regimens have reached groundbreaking levels over the past decade, negative drug interactions between regimens to treat the two conditions still leaves something to be desired.

A recent study published in the Journal of Hepatology found that one of the most popular drugs to treat HCV, Sovaldi (sofosbuvir, Gilead), can have serious drug interactions when used in combination with Viread (tenofovir disoproxil, Gilead), as well as other drugs used to treat HIV (Semedo, 2016 & Shen, 2016). The primary issue discovered by this study (as well as other studies) is that Sovaldi and other Direct-Acting Agents (DAAs) containing sofosbuvir, such as Harvoni (Gilead) and Epclusa (Gilead), can cause liver or kidney toxicity when co-administered with Viread and other HIV drugs. This is of particular concern, as one of the main health issues caused by HCV is liver fibrosis.

The study’s co-author, Bingfang Yan (Ph.D.) suggests that a potential method of getting around this counterindication would be to administer the regimens at different times, or by using different delivery methods (e.g. – administering the HIV regimen first, or through the skin, and the HCV regimen taken orally at a different time).

One issue facing both physicians and patients is that only a handful of long-term or longitudinal studies have been conducting, meaning that both physicians and patients have only counterindication warnings to go upon, that only suggest potential side effects may occur without definitive scientific proof. This can create considerable consternation for all parties involved, as one recommendation is clear: HIV treatment should not be suspended in order to treat HCV infections. The nature of HIV is such that ceasing regimens can lead the virus to develop immunities to the components of the therapy, meaning that a new treatment option will need to be selected. While the negative side effects of HIV drugs has eased over the past thirty years, each patient’s individual body chemistry is unique, and it can take time to find the right regimen for each patient.

A fantastic resource for checking counter-indications between HIV and HCV drugs is HEP Drug Interactions, a project of the University of Liverpool in the United Kingdom. This free website allows users to use the HEP Drug Interaction Checker to see which HCV regimens have counter-indications with drugs to treat virtually any medical condition. The site is sponsored by Janssen, Gilead, Merck, Bristol-Myers Squibb, and AbbVie, each of which make drugs to treat HCV. The site also offers mobile apps for both Apple and Android devices, where users can access the same HEP Drug Interaction Checker information that is available on the full site.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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