Tag Archives: Sovaldi

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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Treating HCV in Pediatric 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

In April of this year, the Food and Drug Administration (FDA) approved the use of Sovaldi and Harvoni (Gilead) for use in treating Hepatitis C (HCV) in pediatric patients aged 12-17. This is an important step in treating HCV in no small part because children and teenagers are considered a vulnerable population. They are, for the most part, not properly equipped to make well-informed decisions about their health, leaving treatment decisions in the hands of the adults who care for them.

Stamp marked, "Approved" next to the initial, "FDA"

Photo Source: 3Dprint.com

Treating pediatric patients is a much riskier prospect, because people outside of the medical community consider children to just be “small adults;” virtually every treatment regimen for every disease must be modified to achieve commensurate outcomes. There are a variety of reasons why this is so, from bodyweight variances between children and adults, to the various ways that physical and chemical changes that occur during the growth and development process from childhood to adulthood can impact how medications behave in pediatric patients. Essentially, “results may vary.”

The new FDA ruling that expands treatment to pediatric patients allows patients weighing at least 77 lbs. to take an unmodified regimen. While access to treatment in adults has proven fraught with hurdles to overcome before being approved by payers, children covered by Medicaid may, in fact, face fewer hurdles than adults. This is due to the following provision: under Federal law, state Medicaid programs must cover “…early and pediatric screening, diagnostic, and treatment services” for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses (Andrews, 2017). While that’s great for patients covered by Medicaid, those covered by private insurers may have a tougher road to hoe, as most within the industry expect the latter payers to largely maintain similar restrictions in pediatric clients as adults.

One of the reason pediatric patients are so vulnerable is that the majority of HCV-infected patients acquire the disease in the womb; only about 20% acquire it through drug use (Andrews). That said, the likelihood is very low – only a 6% chance that babies will acquire HCV if the mother has it.

Hopefully, pediatric patients will face an easier time gaining access to Sovaldi and Harvoni than adults, but only time will tell.

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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Data Analyses Indicate HCV Treatment for All Saves Money; Part 2

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

Last week, HEAL Blog discussed some of the thinking behind a “Treatment for All” paradigm for dealing with America’s burgeoning Hepatitis C (HCV) problem. The argument put forth in the study released in the American Journal of Managed Care (AJMC; Younossi et al, 2017) suggests that adopting a policy of treating every HCV-infected client on government-funded healthcare rosters will ultimately lead to long-term cost savings by reducing the incidence of multiple co-morbidities, such as cirrhosis, hepatocellular carcinoma, and the number of liver transplants. This is a position that advocates (including HEAL Blog) have been arguing for years – since the release of Sovaldi (Gilead) and Olysio (Janssen) in 2013. The pharmaceutical companies who manufacture Direct Acting Agents (DAAs) to treat HCV have been arguing this position, as well.

Read Part 1, “Data Analyses Indicate HCV Treatment for All Saves Money

All of these parties are coming up against the stark reality of the budgetary process. Rather than being calculated based on long-term expenditures, they are calculated using estimated yearly expenditures using the amount of money given to them by the Federal and state governments – resources that are limited, and unlikely to increase without significant increases in tax revenues generated by tax hikes (business, corporate, and personal) or some unexpected increase in profits that comes out of nowhere. Medicaid directors and drug purchasing officials have repeatedly made the claim that treating everyone on their rosters infected with HCV will outstrip their pharmacy budgets several times over. Tom Burns, head of drug purchase for the Oregon Health Authority in 2014, said in an interview that “…Oregon can afford to wait” to see how other HCV drugs develop, and that “…the vast majority [of the 5,600 clients infected with HCV] could wait while we figure out a policy that doesn’t bankrupt this state” (Millman, 2014).

Image of a stethoscope wrapped around a $20 bill , laying next to an open medication bottle

Affordable Healthcare

This line of thinking has been echoed by virtually every state’s Medicaid program. The Centers for Medicare and Medicaid Services (CMS), however, didn’t buy that line, and in 2015 issued an official guidance that reminded Medicaid programs that they are required by law to cover these drugs under section 1927(b) of the Social Security Act (CMS, 2015). Furthermore, states facing litigation related to treating HCV patients have found little sympathy from the Judicial Branch. In May 2016, Federal U.S. District Court Judge John C. Coughenour ordered Washington state’s Medicaid provider to cover HCV drugs for all patients by granting a preliminary injunction that forced the state Health Care Authority (HCA) to halt a 2015 policy that restricted access to the drugs based on a fibrosis score (Aleccia, 2016). This injunction was in response to a class action lawsuit against Apple Health, Washington’s Medicaid program, on behalf of two clients and 28,000 other enrollees. Another Federal U.S. District Judge, Robert Mariani, ordered the Pennsylvania Department of Corrections (DOC) to provide HCV treatment to well-known inmate, Mumia Abu-Jamal (Moran, 2017). While his ruling applied only to Abu-Jamal, the judge went on record, stating that the DOC’s interim protocol for treating HCV “…presents deliberate indifference to the known risks which follow from untreated chronic Hepatitis C.”

The report in the AJCM found that if Medicaid in the U.S. continues its use of restrictions to treatment, the estimated total cost of treating the HCV cohort will come to $9.7 billion, with the majority of costs (50.4%) attributable to downstream costs of care (i.e. – hospitalization costs, outpatient costs, and non-Harvoni pharmacy costs). Conversely, treating all Medicaid patients with Chronic HCV using Harvoni led to a 39.4% savings – $3.8 billion – over the model time horizon and decreased the relative proportion of total costs attributable to downstream costs of care to 18.3% (Younossi).

While most of the cost savings were related to downstream medical cost offsets, even the pharmacy costs attributed to Harvoni treatment over non-Harvoni treatment decreased 2%, from $4.84 billion to $4.75 billion. This is due in part to the 9,618 patients in the cohort potentially eligible for an 8-week regimen of Harvoni to achieve a Sustained Virologic Response (SVR), rather than the traditional 12-week regimen. Treating all Medicaid patients with Harvoni led to a 19.8% savings per SVR, given that earlier treatment of HCV resulted in better health and cost outcomes (Younossi).

Though this analysis is a fantastic tool, another harsh reality is the [potential] repeal and replacement of the Affordable Care Act (ACA). It was announced, last week, that the Fiscal Year 2018 budget resolution has been put on hold, pending the repeal of the ACA (Shutt, 2017). This means that any type of Federal budgeting process for Medicaid (as well as the Centers for Disease Control, and other domestic spending programs) has stalled for the foreseeable future, leaving virtually everyone involved in those organizations in the lurch, waiting for their fates to be handed down to them. Most HIV and HCV advocates, however, are heartened by Tom Cole (R-OK) saying, “We thought it was wrong when Democrats said for every increased dollar on defense, you had to increase domestic. It’s just as wrong to say for every increase on defense you have to cut domestic.” He finished that statement, however, by saying that he believes those increases should be offset on “…the entitlement side of the ledger.” That statement is considerably LESS heartening.

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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Data Analyses Indicate HCV Treatment for All Saves Money; Part 1

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 the introduction of Sovaldi (Gilead) and Olysio (Janssen) in 2013, Hepatitis C (HCV) advocates have argued several points: (1.) that the price for these drugs was/is too high; (2.) that Medicaid is required to pay for these treatments by law; (3.) that ensuring that HCV-infected patients achieve a Sustained Virologic Response (SVR – “cure”) will reduce the cost of care over time. This last point was the subject of a recent report published in the American Journal of Managed Care (AJMC).

The argument goes like this: HCV is a deadly virus that results in liver cirrhosis, eventual liver failure, and ultimately death; it is also can result in a number of co-morbidities that are costly to treat, including cancer, liver disease, connective tissue disease, abdominal pain, and upper and lower respiratory infections. That said, state Medicaid programs consistently place incredibly stringent Prior Authorization (PA) prerequisites on patients in order for their treatment to be covered, that can include mandatory enrollment in a drug or alcohol recovery program or treatment facility, a mandatory period of abstinence from all drugs or alcohol, failure of other, less easily tolerated treatment regimens, and meeting a certain stage of liver fibrosis (F-Score). These prerequisites are put in place in order to defray the high cost of treatment, ultimately resulting fewer patients being approved and less money being spent.

Advocates and economists, alike, have been arguing for years that the long-term costs associated with leaving HCV patients either untreated, or treated with older Pegylated Interferon-based regimens rather than with newer Direct Acting Agents (DAA) that are more easily tolerated and have a higher SVR rate will ultimately cost Medicaid and other government agencies (as well as private payers) more over time. Medicaid officials from several states have argued that treating every patient on their rosters would not just outstrip their existing pharmacy budgets, but do so four-times over, thus bankrupting the program. Drug manufacturers – Gilead Sciences, in particular – have argued that the cost of one-time treatment for a cure is less expensive than the cost of treating other serious conditions, whose cure rate is far lower, and takes far longer, ranging a period of years, to end in a positive result. The reality is that none of these parties are wrong.

The report in the AJMC, “Treating Medicaid Patients With Hepatitis C: Clinical and Economic Impact,” does an excellent job of outlining all the various consequence related to allowing HCV to go untreated until liver decomposition reaches a certain stage and concludes that adopting a “treat all” strategy will ultimately result in a 39.4% ($3.8 billion) savings and decrease the proportion of total costs attributable to downstream costs of care to 18.3% (Younossi, 2017). It also looks at how Medicaid programs arrived at the current “wait for treatment” model that prevents many patients from being approved for newer DAA regimens.

In next week’s post, HEAL Blog will get into the details of their analysis, their methodology, and their recommendation, as well as look into the feasibility of their proposal – that all state Medicaid programs adopt a “treat all” approach to approving HCV regimens.

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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