It seems we've come full circle. I can remember a time in the late '90s/very early 2000s, when the sheer amount of "me too" drugs pouring out of the pipeline seemed to me, well, lazy on the part of Big Pharma. At first the NRTIs, protease inhibitors and NNRTIs were Godsends; but after a much-needed few of each were approved, it seemed that the pharmaceutical companies were taking the easy way out by finding something that worked, tweaking them a bit, slapping a new name on them, chucking them in a bottle and calling it a day.
"Where's the new stuff?" I remember thinking; the new classes of HIV drugs that hit different targets other than protease and nucleoside. Why weren't they pursuing that?
Now, close to a decade and a half later, we have LOTS of drugs. Probably more drugs than any other single disease. But what we don't have are new NRTIs, the first class of drugs approved and the backbone of many HIV drug regimens. After numerous NRTIs approved throughout the 1980s-90s, we now haven't had a single new one since 2003.
So with all the new easier-to-take, once-a-day drugs, why is it important that there are no new NRTIs? Well, if there are so many great drug options as we're led to believe, why then are only 30% of people living with HIV in the U.S. virally suppressed? (37% are on ARVs.) This means that only 3 out of 10 of the 1.2 million HIV-positive people in the U.S. are undetectable.
There are many reasons for this; I'll mention a few. Of course, some people aren't aware of their status (about 14%). Others are still treatment naive. For others, side effects can be so severe that they prevent some people from taking some of the drugs and/or taking them properly. Everyone reacts differently to medications and for some people, certain drugs can be completely intolerable, leaving them not wanting to or unable to take certain medications. With many HIV-positive people experiencing co-morbidities and non-AIDS related-conditions, both of which may require medications, sometimes mixing these drugs can have severe or even toxic results and can make a person extremely ill. Some drugs just can't be mixed together or the combined side effects may be intolerable.
Another issue is drug resistance. Now here's where it gets a bit blurry. Statistics are sorely lacking on drug resistance. Why? Well, think about it. Who would actually benefit from knowing how many people are resistant to antiretrovirals? Other than people with HIV that is, and people living with HIV are not the ones footing the bill for and making the decisions on which studies are done. Pharmaceutical companies? Nah. Why would they want to show that their drugs are failing people who are taking them? The Government? No. That would show what an absolute crock that all of these "ending AIDS" campaigns are. Yes, I know this sounds conspiracy theory, but they want us to believe that HIV is under control. Well it's not. The majority of people with HIV in the U.S. are not virally suppressed and the number of new infections in some groups like young MSMs is growing and growing. The World Health Organization (WHO) has acquired some data from various studies but after 2008 the prevalence of acquired drug resistance is virtually unknown.
What we do know is that in high income countries (U.S., Europe, Japan and Australia) the rate of transmitted drug resistance (when the strain of HIV you become infected with already has some drug resistance) is about 10-17%. The stats for acquired drug resistance (when you develop drug resistance on your own) are much more difficult to find and understand. Because the quality of first- and second-line regimens are now better, we know that the rate is dropping. However, what percentage of people have acquired drug resistance or multi-drug resistance now, we simply don't know.
What is clear is that there are people with HIV who cannot put together a drug regimen due to an inability to take certain drugs because of drug resistance, cross-resistance, counter-indications and side effects that will allow them to reach undetectable levels. Newer classes of drugs, such as integrase inhibitors and those in development like entry inhibitors, have helped and will help some of these people. But more alternatives are needed. One such alternative is ATC.
Apricitabine (ATC) is an NRTI. In phase III, ATC is the furthest along in clinical development of any NRTI. ATC can be used in most people with the M184V mutation and the K65R mutation, so those resistant to AZT (Retrovir, zidovudine), 3TC (Epivir, lamivudine), FTC (Emtriva, emtricitabine) and drugs containing these drugs can use ATC. The side effects, so far, seem to be minimal.
So why isn't ATC available? Real simply: money. ATC is made by a small pharmaceutical company in Australia that doesn't have the millions for the one last trial the FDA needs to approve it if the last trial shows the same positive results as the other trials of ATC have. This isn't a case of big bad Pharma. In fact, key individuals in this company, Avexa, have been fighting for years to keep ATC in play. Of course, any pharmaceutical company's goal is to make money, but this one actually cares about people with HIV. They simply don't have the funding for the 300-person study that is required to make this drug available.
Almost all of the HIV drugs we have now have used the federal clinical trial system (AIDS Clinical Trials Group studies, or ACTGs) to test their drugs. These trials are paid for by the National Institutes of Health (NIH) with our tax dollars. With all the money they've made on drugs, companies like Gilead, ViiV, Pfizer and Agoroun certainly didn't need the government to kick in. But they did. So why won't the ACTG's pay for the ATC trial?
Currently ATC is being offered in an expanded access program (EAP) for the U.S. and Europe. As with some expanded access programs, this is a paid program that costs about $700/month. Now obviously most people living with HIV aren't going to be able to afford it. But those who have no other drug options, a viral load through the roof, and declining CD4s who can afford to pay, need to be aware that this option is available. As advocates and activists, we need to help those who are too sick to help themselves right now, the same as was done in the 1980s and 1990s.
I'm just one person. I'm doing all I can but that's limited. There has to be a way to get this drug to people through expanded access who can't afford to pay for it, to make those aware of the EAP who can afford it and to make the government pay for the phase III trial that could make ATC available to anyone who needs it.
So what can you do? Here are some other things that might help:
Check out our Facebook page on ATC where you can get more information about ATC and follow, support and participate in the campaign for ATC.
Does your local HIV clinic or University conduct studies as part of the AIDS Clinical Trials Group? If they do, join their community advisory board that provides input into what studies are performed. Voice your opinion. Be heard. Tell them you want ATC and other drugs for drug resistance or new classes of drugs that would work for people with multiple drug resistance.
Write or call Tony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH. Tell him the same. Here's his email address: firstname.lastname@example.org and phone number: 301-496-2263. Tell them we need the confirmatory Phase III clinical trial of Apricitabine.
Call or write to your local representatives and explain the situation to them. Tell them you think more money should be directed towards drug resistance.
Tell your doctor about ATC and provide him the letter on our Facebook page that gives him the information to enroll people into the ATC expanded access program. Ask him to call the FDA and tell them that patients need financial support to get this drug, how can we make that happen. Call the FDA Office of Special Health Issues (OSHI) yourself and tell them the same. Here's how to contact: Call 301.827.4460 or email Rklein@oc.fda.gov.
Do you write? Write an article about ATC or drug resistance and the need for salvage therapies and new HIV drugs that address drug resistance. Submit it to any of the numerous HIV or general media publications. Use the info on the Facebook page as a resource.
New combination HIV drugs are helping those newly treated to lead healthier lives. However there are many individuals who are not doing well and don't have the drug options they need. Together we can make a difference for them.
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