How Will Generic Drugs Affect HIV Treatment in the U.S.?
An Interview With Treatment Action Group's Tim Horn
October 29, 2014
The latest issue of the Treatment Action Group (TAG) publication TAGline focuses on generic drugs and the role they are poised to play in the treatment of HIV, hepatitis C and tuberculosis (TB) in the U.S. In light of the Affordable Care Act and several drugs scheduled to go off patent in the next few years, questions are in the air regarding the cost of medications and what treatment regimens may look like in the near future.
To get the latest, we spoke with Tim Horn, the HIV project director at TAG, and editor of TAGline.
Can you tell us a little bit about why you chose generics as the topic for the fall issue of TAGline?
I think that generics have long been such a critical component about the response to not only HIV, but also tuberculosis (TB) and, hopefully, hepatitis C for many years now so that definitely, at least globally, the issues around generics remains ... critical to our response to a variety of epidemics. So that's always something that's on our radar.
What's interesting, though, is that because so many of our TAGline readers are in the U.S., there is this increasing interest in really the potential for generics, particularly with response to HIV in the United States.
I'm happy to talk a little bit more about that picture, in the sense that I think we're at a very interesting point in time when it comes to the generics in the U.S., in that many of the drugs that are commonly used today are approaching their patent expirations, which is something of a testament to modern-day antiretroviral therapies' durable overall safety and efficacy. While we've certainly seen other HIV medications that enter the generic marketplace in the U.S. that became available long after the drugs had fallen out of favor, largely due to efficacy, safety or dosage problems.
So, essentially, we're looking at a number of drugs that we've been using for a lot of years, with known safety and efficacy, [and] their patent expirations are coming up. So we can really begin to conceptualize the use of generics in the U.S. For so many years, both U.S. activists and global activists, we've really been focusing on the potential for generic utilization in low-income countries; because of that we've seen the annual cost of therapy in a lot of lower-income countries for really durable, highly effective and safe therapy really drop below $200 per year. The fact is that this is a real tremendous benefit that we've seen globally.
So now that we're in sort of the twilight of the patent lives of some of the most effective [drugs] that we currently use here, it's really now time to start envisioning: Can we start to bring some of those cost savings home?
Can you maybe take a second to list some of the medications that have patents coming close to expiration time? Especially the ones that would probably have the most impact on people living with HIV, or hep C, or TB.
Sure. Well, certainly, in the U.S. -- and I can speak directly to the issue of HIV -- take, for example, efavirenz. Efavirenz, it's got the brand name Sustiva. It's really been one of the critical drugs in Atripla, which has been really the dominant agent for utilization for the treatment of HIV for many, many years. Well, efavirenz is going to be coming off of patent soon. And it's interesting because our initial thought was that efavirenz would be coming off patent and available generically sometime in 2013. And then, just based on some legal wrangling, then it became 2015. And now we've received confirmation that it won't be until December 2017.
Really, there are two lessons here. No. 1, which is in developing strategies for the arrival of generic antiretrovirals in the U.S., patent is a bit frustrating; and, two, the ability of attorneys to prolong name-brand patents is both amazing and outrageous. But it still speaks to the fact that a number of drugs -- like efavirenz -- are coming off in 2017. And, really, there are, just based on some estimates, other drugs that we do think will be coming off of patent, or close to coming off of patent, in the next several years, including darunavir (which we know as Prezista); lopinavir/ritonavir (Kaletra); and by 2017, we're looking at the possibility for tenofovir and atazanavir.
All of those drugs that I've just mentioned, really have been real key players, at least in first-line therapy, for people living with HIV. So a lot of these drugs are really proven. A lot of these drugs, we're actually utilizing them long enough that we might see their patents expire. So therefore, it raises the question about: What role might they play as generics in the U.S.?
Also of interest is that when you take a look at abacavir, it's currently available generically. Lamivudine is currently available generically. And if you think about it, you have, with Tivicay, with dolutegravir -- well, a lot of the indications under the HHS preferred regimens for antiretroviral therapy is Tivicay plus abacavir/3TC, including Triumeq, which was the fixed-dose combination tablet that was approved earlier this year.
So, you have dolutegravir plus abacavir plus lamivudine. It is a preferred regimen. And abacavir and lamivudine are currently available generically. So we can begin to think about their role for the use of those two as a component of a generic.
What do you think are going to be the ramifications of the availability of generics on things like the AIDS Drug Assistance Program (ADAP), or even, in some states, pre-exposure prophylaxis (PrEP) DAP?
What's interesting is that Rochelle Walensky, she and her colleagues produced a paper a couple of years ago that's basically just taking a look at efavirenz. Once efavirenz becomes available generically, the potential for cost savings and the potential cost savings through the U.S. health care system was really substantial. Some of the numbers that she and her colleagues came up with were really just tremendous.
For example, if you used a regimen that consisted of your generic efavirenz, generic lamivudine, plus brand-name Viread, the cost savings would be $920 million in the first year of availability alone. If generic efavirenz is paired with Truvada, then the cost savings would be $560 million. And both of those sets are compared to continuing brand-name Atripla.
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