Tag Archives: Epclusa

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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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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An Almost Cleverly Named HCV Drug to Beat Them All

By: Marcus J. Hopkins, Blogger

The U.S. Food & Drug Administration (FDA) and Gilead Sciences – maker of the most commonly prescribed Hepatitis C (HCV drugs), Sovaldi and Harvoni – came out with yet another fantastic cure for Hepatitis C: Epclusa. What makes this drug a real miracle? Let’s take a look:

Epclusa is the first pan-genotypic HCV therapy, meaning that it works across HCV Genotypes 1-6. This is a potential coup for Gilead, who has faced occasional threats from other manufacturers whose drugs targeted those genotypes that neither Sovaldi, nor Harvoni (alone) addressed. The new ingredient – velpatisvir – is used in combination with the sofosbuvir (Sovaldi) from both of their earlier regimens, which one must assume is what allows it to be used across all genotypes with an average SVR (“cure”) rate of 94%. This advancement, alone, is amazing, given how difficult to treat HCV was a scant four years ago.

The second-best bit of information about Epclusa is its introductory Wholesale Acquisition Cost (WAC) of “only” $74,760 for twelve weeks of treatment.

Pill bottle of Epclusa medication for Hepatitis C

Photo Source: InfoHep.org

Gilead has become the face of congressional-, physician-, advocate-, and payer-led accusations of price gouging, with Sovaldi coming in at $84,000 and Harvoni at $94,500, and they have clearly taken the calculated risk of introducing Epclusa at almost $10k cheaper than one of its component drugs by itself. After three years of price-related bad press, there was great concern within the HCV world that their much lauded pan-genotypic drug was going to easily cost over $100k, and given the range of genotypes it’s used to treat, it stood to reason that this would be the case. Gilead, however, seems to have either learned from their miscalculation of what consumers, states, and insurers were willing to pay, or they’ve decided that the record profits they’ve enjoyed from their previous successes allowed them to offer this new drug as a significantly lower price. Either way, even before discounts and rebates, Epclusa’s price point is a net win for all parties.

My only beef with Epclusa has literally nothing to do with its efficacy or its price; rather, I’m a bit miffed at Gilead for not taking the name one step further to make it truly clever. “Epclusa” is fine, and all – the “-clusa” part clearly referencing its all-in”clus”ive pan-genotypic nature – but they really missed a golden opportunity by not placing an ‘H’ at the beginning, making it “Hepclusa,” allow for both “Hep-“ for “Hepatitis” and the ‘c’ in “-clusa” to serve a dual purpose for “Hep C.” Maybe, it’s the writer in me, but come on guys: if you’re going to be amazing, be amazing all the way.
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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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