Clay: What are some of the brand names for a TAF tenofovir drug?

Whitney: So the first TAF drug that was approved was called Genvoya, and it was approved in late 2015. And then Odefsey is another TAF drug that was approved in 2016. And then one that maybe is the most well-known is called Descovy, and that was also introduced into the market in the US in 2016. Truvada was perhaps one of the most well-known of the TDF drugs. Descovy is exactly the same as Truvada except it has TAF instead of TDF. So then it has also been approved by the FDA for PrEP. So, for prophylactic treatment of patients who are currently HIV-negative and as a preventative measure. So Descovy is one of the biggest TAF drugs on the market right now.

Clay: So Descovy may be seen as the medication that’s really replacing Truvada. And hopefully informed doctors will now be making that transition to Descovy. Is that right?

Whitney: Yeah. So I think what we’ve seen is that a lot of folks and the biggest chunk of the market has moved to the TAF iteration, and there are certainly a large number of patients who have been switched over to Descovy. And I think prescribers are using that more widely now.

Clay: So speaking of doctors and how they’re informed, it’s my understanding that Gilead promoted these TDF medications for years and often told doctors in the United States that there were no toxicities or very few, and let me say, based on what I read, they gave more dire warnings in Europe than they did in United States. Is that your understanding?

Whitney: We talked a lot about the warning labels that accompany prescription medications. And one of the things that we’ve seen is that for years, the warning labels in Canada and the European Union countries were much much stronger. They disclosed a much more closer relationship, basically between the TDF medication and then nephrotoxicity, and even some bone issues which we haven’t touched on a lot today but is another one of the injuries that we believe the TDF class of drugs could cause. So yes, you’re exactly right, Clay. There were stronger labels in other parts of the world, and not in the US. So a patient in EU country might receive Truvada and they might get a lot more information about the possible side effects, whereas a patient in the US wouldn’t have been given those same kind of warnings. And that’s really the crux of a lot of this, right? I mean, years ago, direct to consumer advertising in pharmaceuticals wasn’t a thing. That’s been in the last 20 or 30 years. So, it’s my view that if pharmaceutical companies are going to be able to market directly and advertise directly to patients, then they should disclose all of the risks that could happen and they should disclose the risks that are more likely to happen. It’s not the laundry list of X, Y, and Z. If there’s a significant or an increased risk of something as serious as kidney failure happening, then a patient needs that information so that they can decide with their doctor if it’s worth the risk.

Clay: I think that’s exactly right. That’s maybe the best point of all. The tragedy, especially when a patient is dealing with such a scary diagnosis as HIV, is that he and his doctor might not know the full extent of the side effects and the potential long-term problem that’s outside of HIV or AIDS.

Whitney: That’s absolutely right.

Clay: So we’ve talking about TDF and Tenofovir and the potential injuries that it can cause patients, and we’ve talked about how the studies indicate that it can be toxic to kidneys and damage kidneys and cause kidney failure. You mentioned the bones, so tell me about what you know about bone injuries.

Whitney: It’s interesting and it’s something we’re still learning a lot about. But another one of these issues or side effects we’ve seen from TDF/tenofovir is causing stress fractures or fractures in various parts of the body. So rib fractures from non-traumatic events, femoral fracture, so somebody might get a fracture in the portion of their leg that’s above their knee, and again, not falling down, not getting in a tragic event. It’s an overall decrease in their bone mineral density that then can lead to osteoporosis or osteopenia and then make them more likely for some of these fractures to occur.

Clay: So we’ve got this tenofovir drug, it’s been out there for a while, and even though it’s cycling out of the marketplace for 15 years, thousands of people took the drug, and now we’ve got people that are injured. Kidney damage, kidney failure, bone injuries. So litigation has followed.

Whitney: We represent a couple thousand individual plaintiffs in tenofovir lawsuits that have been filed in Federal Court in the Northern District of California. That’s where Gilead’s home office in the US is located.

Clay: So is that at the multidistrict litigation site?

Whitney: Yeah. So technically, it’s not been designated MDL yet, but it’s a consolidated litigation. That’s in federal court. We’re working that up. We represent a bunch of individual plaintiffs who have had these injuries occur. And then we’re moving forward with those cases. There’s also a consolidated litigation in state court in California. That’s kind of referred to as the JCCP litigation. So that’s in state court in California as well. And those cases are being worked up against Gilead, kind of on a different schedule, but the same general idea as what we’re doing.

Clay: And just so everybody understands, you’re not representing folks in a class action? These are consolidated individual cases with individual claims.

Whitney: That’s absolutely right, Clay. We’re representing individuals. What often happens is, I’m sure folks know from listening to you, is where you have a bunch of people who have been injured by a medication instead of trying to recreate the wheel two thousand times in different venues across the country, it makes sense to have all those folks consolidated in front of one judge so that your discovery rulings, getting document production, getting evidentiary rulings, all of that can be consistent. And then also each plaintiff isn’t having to take on the burden of fighting against a corporate behemoth like Gilead Sciences. So, this way is the best of both worlds. You get the efficiency of the consistent pre-trial rulings and evidentiary rulings, but it’s still everyone’s individual lawsuit and they’re not bound with other folks who may have different injuries and different claims. The individual folks who have been injured by the medications are still in charge of their own cases, but we’re working them up together for at least some of this initial stuff.

Clay: Got you. Well, I appreciate you explaining that because a lot of times I get calls, and I’m sure you do too, they talk about class actions and they sometimes worry about that. They don’t want to be just another widget in a massive class action. And that’s not the case in this litigation or in most product cases, most product liability cases. It’s never a class action. It’s individuals fighting the big company for fair compensation. Well, Whitney, this has been fantastic. Those are the questions I have. I really appreciate you spending some time with us.

Whitney: Thanks for having me, Clay.

If you have taken a tenofovir drug like Truvada and suffered kidney damage or bone injuries, please call me at (919) 830-5602 to discuss your possible case against Gilead Sciences. Good luck.

Today, we’re going to talk about the HIV medication, Tenofovir. This was a medication sold for years to delay the progression of HIV. As studies are beginning to show, there were problems with the medication causing toxicity to kidneys, bone loss and bone injury. Whitney Butcher is an attorney with Hilliard Martinez and Gonzales, and today we’re going to talk about Tenofovir, the brand name medications that derive from this compound, the problems that were discovered and the litigation that has inevitably followed all this.

Let’s start at the beginning. Most people know that HIV is the virus that causes AIDS, what is an antiretroviral drug?

Whitney Butcher: So, those were one of the first class of drugs that were basically brought to market to help stop and slow the spread of HIV. Once a person contracts HIV, the goal of these medications is to target the cells and prevent them from replicating so that an HIV diagnosis doesn’t progress into full-blown AIDS which can of course be life-threatening and very dangerous.

Clay: What is Tenofovir?

Whitney: Tenofovir is a compound that’s in a class of nucleotides, and it’s very effective at preventing the replication of HIV, but it can be nephrotoxic meaning that it can harm patients’ kidneys. Tenofovir is the active compound that’s in a number of different antiretroviral medications. Truvada is one that a lot of folks have heard of.

Clay: In reading about this medication, when they were formulating it, around 20 years ago, it was only meant to be administered in an intravenous form, and the company, Gilead Sciences, was trying to make it into a pill form. Can you talk a little bit about that and kind of the downside and upside of that?

Whitney: So while Tenofovir is effective, it can’t be taken orally, which, as you just said Clay, means that you can’t put it by itself in a pill and have somebody take it. It just doesn’t work that way. So, what happens is, these delivery agents are added to the compound Tenofovir. The first drug involving Tenofovir was the class of medications that I’ll call TDF, that’s Tenofovir Disoproxil Fumarate, or TDF. The very first TDF medication that came on the market was called Viread, and that was approved in 2001. So, TDF is Tenofovir, the drug that will prevent the cells or slow the cells replicating the virus, and then the DF, the Disoproxil Fumarate, that’s the delivery agent. That’s what allows the patient to take Tenofovir orally in pill form and then allows the medication to get to the cells to do the work that it’s supposed to. So I kind of make a joke that the Tenofovir is the Amazon package that you’ve ordered, and the DF is the Amazon Delivery Agent, that’s going to deliver it to your front door. So, you’re not going to get the package unless you’ve got the DF. Tenofovir is not getting into cells without the delivery agent, the DF, that accompanies it.

Clay: Let’s move from talking about Tenofovir and going to TDF. What are some of the brand names that were out there under that TDF umbrella.

Whitney: Absolutely. The first one was Viread. That was approved in 2001. The next name brand TDF drug and, perhaps the biggest, was Truvada, and that was approved in 2004 by the FDA. And so, Truvada features TDF plus another component. So, with Viread, even though it was effective, patients would have to take lots of other medications. In the early days, HIV patients would talk about having to take like 10 different pills per day. So Truvada was the first to combine TDF plus an additional medication. The other interesting thing about Truvada is it was actually the first medication that was approved for PrEP, so what that means is for patients who might be at a higher risk of contracting HIV but are currently negative. The FDA approved Truvada to be used by those, overall, very healthy people as a preventative measure. Some other TDF medications, Atripla was a big one. Atripla, as the name suggests, kind of speaks to triple. So there’s three different compounds that make up Atripla. Another one, Complera, and then the last in the TDF class was Stribild, which had four different components to it, again, including TDF. And Stribild came out in 2012.

Clay: TDF is considered toxic to kidneys. Is that correct?

Whitney: Yes. As we’ve gotten more information and as we’ve had a chance to talk to patients who took TDF oftentimes years and years, what we’ve learned is that…so the TDF drugs, again, the Tenofovir is trying to get into the cells to prevent the replication. It’s less stable of a compound. And so, what happens is the changeover. So you take it as an oral pro-drug, right? Your body starts converting it into Tenofovir before it reaches the target cells, meaning that you get a greater systemic exposure. So, Tenofovir, at its core, is nephrotoxic, meaning that it can harm your kidneys. It can do positive things, but it can also harm your kidneys. And so by allowing for this greater systemic exposure, what we’ve seen is that TDF medications do have a higher likelihood of causing problems with people’s kidneys. And in the worst cases causing end-stage kidney failure that requires them to be on dialysis, which is really an awful thing for anyone to go through.

Clay: It’s just a shame because these are individuals, these are patients with a terrible illness in a lot of cases. It’s an awful choice they have to make. Obviously, they didn’t know for years that this medication was potentially that harmful, and yet, when they’re facing the prospect of AIDS, the development of AIDS, it’s horrendous choice they have to make. In my reading, it seems like the company that developed TDF knew even prior to 2001, when the first class of these drugs came out, that TDF was toxic to the kidneys and quite potentially harmful to the human body. Isn’t that correct?

Whitney: That’s certainly what we believe. We’re still in the early stages of discovery. So we’re working through a lot of that. But yes, Tenofovir was nephrotoxic. Everybody knew it was nephrotoxic. We believe that the company knew that TDF had a greater likelihood to cause kidney damage in patients before it was approved.

Clay: An excellent point you’re making. And let’s stop for a second and say we’re both attorneys, and some of the things we’re talking about today are allegations made in complaints against the company. And the job of the plaintiffs is to go out there and prove it, so Gilead is going to certainly deny a lot of the allegations that we talked about today. Speaking of allegations and things we’ve discovered, along the way, at some point, Gilead came up or developed a safer alternative to TDF. Isn’t that true?

Whitney: So this is important. I don’t mean to sound like I’m correcting you because you’re the boss Clay, but it wasn’t at some point down the line. It was initially, I mean, we believe that they had these two drugs in the hopper at about the same time. So TDF and then its safer alternative, TAF, were kind of in existence at the same time. And Gilead, we believe, made the choice to shelve TAF, which ultimately proved to be a safer alternative, meaning it was as effective, if not more so, at preventing the spread of HIV, but it didn’t have the side effects of kidney failure and then ultimately bone mineral density issues and other fractures that we saw with the TDF drug. So it wasn’t that they got TDF on the market and they stumble on TAF at some time later. We believe that it was there to be seen and developed instead of TDF from the beginning.

Clay: I appreciate that distinction. And that actually gets to the heart of this thing and makes it a little more sinister if the plaintiffs are able to prove that it’s true. Tell me how TAF is noticeably safer than the TDF.

Whitney: So again, the active drug in TDF or in TAF is Tenofovir. And so, TAF stands for Tenofovir Alafenamide Fumarate. So the AF are the delivery agents and they’re more stable. What that means is when you take the oral medication, that is TAF, it stays in that encapsulated form longer and doesn’t begin the conversion process to Tenofovir until it actually reaches the target cells. So, it’s not causing all this systemic exposure because the switch over to TAF or Tenofovir isn’t happening while it’s in the body. It’s more stable. It’s a more stable compound, and so, it maintains its integrity until it gets in the target cells and then switches over to Tenofovir, which makes it more effective, we believe. But then also, it’s not causing the systemic exposure and being processed through the patient’s kidneys which can then cause a lot of the kidney issues that we’ve seen with folks who took Truvada and other TDF medications.

Clay: So to say it back to you: with both medications, TDF and TAF, their usefulness is because of the Tenofovir that’s present and it’s effective in slowing down HIV progression. But that said, the study shows that TAF is markedly safer than the TDF. Now, Gilead had both around the same time, we believe, chose to keep selling the TDF branded medications. Do you have a theory why?

Whitney: The theory would be to maximize profits. I hate to say it as bluntly as that, but with both on the market, you’re competing for the same population of patients. So, if you have one, that’s the only option on the market. You can extend the patent life of the drugs. Everybody’s heard of generic medications, right? So there’s a period of time, seven or ten years, when a drug gets approved. It’s the only game in town, if you will. And so, we believe, to maximize profits, Gilead wanted TDF drugs to be the only game in town, the only option with Tenofovir for prescribers so as to maximize their profits. Then, when they were approaching the end of patent life of the TDF medications, they would roll out the TAF drugs because they wouldn’t have the protection from generic competitors for TDF, so let’s try to switch everybody over to TAF because those are newly approved, we’re the only game in town now with the TAF drugs.

Clay: The implications are horrifying, if this is true, that for twelve, fifteen years, Gilead was making sure that TDF was front and center, and then they slow-waltzed the TAF medications which they knew to be safer. And again, some of these are allegations that must be proven. But I did read that the TDF drugs were the major part of the sales figures for Gilead in the early part of the 2000s, like as much as 68% of all Gilead sales in 2003. Is that your understanding?

Whitney: I’m not familiar with that number, but I have no reason to doubt it; it sounds right.

Clay: I talk a lot on my site about the profit motive that drives a lot of these corporations. We all know every corporation has a profit motive, but the extent to which the profit motive can drive devastating decisions for public health is just [horrifying]. I stumble on a new example of it every week it seems. So, in 2015, the TDF drugs were getting closer to the expiration of the patent, and Gilead started to move toward TAF medications. Is that right?

Whitney: Yes.

In Part 2, Clay and Whitney discuss the injuries that Tenofovir can cause, and the emerging litigation against Gilead.