Editorial

Passing the Torch from Implementation to Eradication

As we’ve talked about in many editorials over the last several years in HCV Next, the hepatitis C treatment revolution followed in the wake of the pioneering work done in HIV, especially with regard to drug discovery and development.

The similarities between HCV and HIV are striking: they’re both RNA viruses; they both have a quasi-species with dozens of highly related, yet genetically distinct, viruses that co-exist; they both replicate at extraordinary rates – anywhere between 1 to 10 billion copies per day for HIV and 100 billion to 1 trillion copies for HCV; they’re both nine kilobases long; and the drugs used for treatment have very similar names – protease inhibitors, nucleotide and non-nucleoside inhibitors.

But the huge difference, of course, is that HCV is curable with as little as 6 to 12 weeks of treatment.

The work that went into development of small molecules that inhibit replication in HIV was put into action in HCV and almost immediately enabled us to treat and cure hundreds of thousands of people in the United States and millions of people around the world. That set the stage for a social revolution, in clinical terms, where we could begin to imagine elimination of HCV globally.

The barriers to eradication are huge, however.

Barriers to Eradication

First and foremost is identification of people who are infected. This requires widespread universal testing, while rejecting the mindset of testing only certain subsets of patients such as the baby boomers. That approach was reasonable at the time it was proposed, but HCV can infect many different populations of individuals, something we are seeing more and more with the ongoing opioid epidemic, for example.

The only way we are going to eradicate HCV is by identifying every person who is HCV infected and getting them linked to care.

Michael S. Saag

The second large barrier – and the biggest barrier – is access to treatment. The major hurdle here isn’t that drugs aren’t made in sufficient quantities; but rather they are incredibly expensive, especially in developed countries.

While it’s understandable that the companies that manufacture these agents need to recoup their investment for research and development, the pricing is such that it is not affordable to most health care systems if we are to treat everyone who is infected. Fortunately, with competition, pricing has come down quite a bit over the last several years. But to eliminate HCV, lower drug prices are needed.

As we’ve discussed in these editorial pages over the past few years, innovative approaches for drug purchasing are likely required, as was employed in Australia. In that case, the country made a deal where as much drug as was needed would be supplied over a several year period for a single price. This approach incentivized providers to test and treat all patients in their health care system before the time period ended.

Until we can overcome the barrier of cost, the notion of eradication – at least in the United States and most other developed countries – will remain an elusive target.

Another barrier to eradication is making sure we have enough treaters – people who understand the biology of HCV, the nature of liver disease, and are comfortable prescribing. Luckily, this barrier has been manageable and addressable thus far.

For us to be successful, as many primary care providers as possible should join the army of clinicians who treat HCV. The commitment is significant and requires some degree of training through workshops and continuing medical education. Fortunately, there is a finite amount of knowledge that needs to be mastered and it is readily doable.

I have been impressed with the eagerness with which a lot of primary care providers embraced the concept of treating and curing HCV. We should continue to host educational programs that train and encourage primary care providers to treat and cure their patients so that every patient they follow will be HCV free. I encourage all primary care providers to test every person in their primary care practice for HCV. For those that test positive, treat them within your primary care practice. Take on this challenge to eradicate hepatitis C.

If a patient has progressed to end-stage liver disease, call upon your hepatology colleagues. Eradication of HCV requires collaboration between hepatologists and those who are engaged in primary care.

As a reminder to both primary care physicians and specialists, the HCV Guidelines (www.hcvguidelines.org) remain a living, frequently updated reference for patient care. The guidelines are phenomenal. Using these AASLD/IDSA guidelines is a tremendous resource that is only a mouse-click away to guide providers through modern treatment approaches easily.

Revolutions Leave Challenges

In closing, we have witnessed an incredible, unprecedented revolution in the treatment of a viral infection. Never have we seen an infectious disorder go from being unnamed to cured in less than 3 decades. Prior to 1989, the infectious cause was not even described as hepatitis C. By the turn of the century, the ability to test small molecules became possible, leading to the quick development and the release of very active drugs within a decade. This dove-tailing of events has created the opportunity for us to cure as many people as we can find and treat today.

Over the next decade, our challenge is to comprehensively test everyone, transition those who test positive into care, treat them with affordable regimens, and then follow them appropriately based on their fibrosis status. Lastly, we should track those who are at ongoing risk for reinfection. Only when we put each of those pieces into consistent practice can we begin to think about elimination of HCV in the United States and around the world.

With the close of this publication, the torch passes but it must be kept lit until eradication is achieved.

As we’ve talked about in many editorials over the last several years in HCV Next, the hepatitis C treatment revolution followed in the wake of the pioneering work done in HIV, especially with regard to drug discovery and development.

The similarities between HCV and HIV are striking: they’re both RNA viruses; they both have a quasi-species with dozens of highly related, yet genetically distinct, viruses that co-exist; they both replicate at extraordinary rates – anywhere between 1 to 10 billion copies per day for HIV and 100 billion to 1 trillion copies for HCV; they’re both nine kilobases long; and the drugs used for treatment have very similar names – protease inhibitors, nucleotide and non-nucleoside inhibitors.

But the huge difference, of course, is that HCV is curable with as little as 6 to 12 weeks of treatment.

The work that went into development of small molecules that inhibit replication in HIV was put into action in HCV and almost immediately enabled us to treat and cure hundreds of thousands of people in the United States and millions of people around the world. That set the stage for a social revolution, in clinical terms, where we could begin to imagine elimination of HCV globally.

The barriers to eradication are huge, however.

Barriers to Eradication

First and foremost is identification of people who are infected. This requires widespread universal testing, while rejecting the mindset of testing only certain subsets of patients such as the baby boomers. That approach was reasonable at the time it was proposed, but HCV can infect many different populations of individuals, something we are seeing more and more with the ongoing opioid epidemic, for example.

The only way we are going to eradicate HCV is by identifying every person who is HCV infected and getting them linked to care.

Michael S. Saag

The second large barrier – and the biggest barrier – is access to treatment. The major hurdle here isn’t that drugs aren’t made in sufficient quantities; but rather they are incredibly expensive, especially in developed countries.

While it’s understandable that the companies that manufacture these agents need to recoup their investment for research and development, the pricing is such that it is not affordable to most health care systems if we are to treat everyone who is infected. Fortunately, with competition, pricing has come down quite a bit over the last several years. But to eliminate HCV, lower drug prices are needed.

PAGE BREAK

As we’ve discussed in these editorial pages over the past few years, innovative approaches for drug purchasing are likely required, as was employed in Australia. In that case, the country made a deal where as much drug as was needed would be supplied over a several year period for a single price. This approach incentivized providers to test and treat all patients in their health care system before the time period ended.

Until we can overcome the barrier of cost, the notion of eradication – at least in the United States and most other developed countries – will remain an elusive target.

Another barrier to eradication is making sure we have enough treaters – people who understand the biology of HCV, the nature of liver disease, and are comfortable prescribing. Luckily, this barrier has been manageable and addressable thus far.

For us to be successful, as many primary care providers as possible should join the army of clinicians who treat HCV. The commitment is significant and requires some degree of training through workshops and continuing medical education. Fortunately, there is a finite amount of knowledge that needs to be mastered and it is readily doable.

I have been impressed with the eagerness with which a lot of primary care providers embraced the concept of treating and curing HCV. We should continue to host educational programs that train and encourage primary care providers to treat and cure their patients so that every patient they follow will be HCV free. I encourage all primary care providers to test every person in their primary care practice for HCV. For those that test positive, treat them within your primary care practice. Take on this challenge to eradicate hepatitis C.

If a patient has progressed to end-stage liver disease, call upon your hepatology colleagues. Eradication of HCV requires collaboration between hepatologists and those who are engaged in primary care.

As a reminder to both primary care physicians and specialists, the HCV Guidelines (www.hcvguidelines.org) remain a living, frequently updated reference for patient care. The guidelines are phenomenal. Using these AASLD/IDSA guidelines is a tremendous resource that is only a mouse-click away to guide providers through modern treatment approaches easily.

Revolutions Leave Challenges

In closing, we have witnessed an incredible, unprecedented revolution in the treatment of a viral infection. Never have we seen an infectious disorder go from being unnamed to cured in less than 3 decades. Prior to 1989, the infectious cause was not even described as hepatitis C. By the turn of the century, the ability to test small molecules became possible, leading to the quick development and the release of very active drugs within a decade. This dove-tailing of events has created the opportunity for us to cure as many people as we can find and treat today.

PAGE BREAK

Over the next decade, our challenge is to comprehensively test everyone, transition those who test positive into care, treat them with affordable regimens, and then follow them appropriately based on their fibrosis status. Lastly, we should track those who are at ongoing risk for reinfection. Only when we put each of those pieces into consistent practice can we begin to think about elimination of HCV in the United States and around the world.

With the close of this publication, the torch passes but it must be kept lit until eradication is achieved.