When HIV drugmaker ViiV announced in late 2017 that it had received Food and Drug Administration (FDA) approval for Juluca (dolutegravir/rilpivirine), the first effective two-drug, single-pill HIV regimen in the modern treatment era, community activists hoped that its price would reflect the fact that it contained one drug fewer than three-drug tablets like Complera (rilpivirine/tenofovir disoproxil fumarate/FTC), Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), Stribild (cobicistat/elvitegravir/FTC/tenofovir disoproxil fumarate), and Triumeq (abacavir/dolutegravir/lamivudine), all of which are generally priced between $2,600 and $3,500 a month in the U.S.
But that wasn't the case at all. ViiV priced Juluca at $2,579 in the U.S., roughly the combined cost of the two drugs it contained, Tivicay (dolutegravir) and Edurant (rilpivirine). By comparison, Juluca costs about $900 a month in the UK.
"They could have set a significantly lower baseline for two-drug regimens that would really have helped lower spending on HIV meds in the U.S.," says Jeremiah Johnson, HIV project director at Treatment Action Group, an HIV advocacy organization. "It was a real disappointment."
All About Dovato
On April 8, 2019, the FDA approved ViiV's next two-drug regimen, Dovato. Unlike Juluca, which was approved as a "maintenance" regimen that people could switch to once they've already achieved an undetectable viral load on another regimen, Dovato was approved as a first-line treatment option for people who have never taken HIV meds. Pedro Cahn, principal investigator of the GEMINI study that led to the drug's approval, said in a ViiV press release, "Treatment-naive people living with the virus have a powerful option that delivers non-inferior efficacy to a dolutegravir-based three-drug regimen, allowing them to take fewer ARVs [antiretrovirals] and get and remain suppressed."
Treatment-wise, Dovato is no breakthrough pill. It's the same regimen you can already get with two pills daily instead of Dovato's one: Tivicay (dolutegravir) plus a generic version of Epivir (lamivudine, 3TC).
Also, in the GEMINI study, Dovato proved overall to be merely as good as the three-drug regimen (dolutegravir, a.k.a. Tivicay, plus emtricitabine and tenofovir disoproxil fumarate, the two drugs in Truvada) it was tested against, on both efficacy and safety -- but not better. In people who started treatment with a CD4 count of 200 or lower, it actually proved to be less effective at suppressing the virus than the three-drug combo.
Additionally, Tivicay, which is one component of Dovato, is being scrutinized for possible links to weight gain. "The elephant in the room here is clinical obesity," says Andrew Hill, M.D., a pharmacology expert at the University of Liverpool in the United Kingdom. "ViiV never presented data on body weight from the GEMINI trials [whose data led to Dovato's FDA approval]. We need to know these results before deciding whether this new drug is a benefit to patients."
What About the Price?
ViiV has priced Dovato at $2,295 monthly. That's slightly more than the roughly $2,240 combined price of Tivicay and generic 3TC, and just below the $2,300 to $2,500 window that had been called for by the Fair Pricing Coalition, a group of HIV treatment activists who lobby the government and pharma to freeze or lower HIV drug prices.
In a press release, the group "expressed its appreciation for a wholesale acquisition cost (WAC) that bucks the trend of runaway HIV drug pricing."
"After the blistering annual launch prices set for the two most recent single-tablet regimens, Biktarvy ($35,000) and Symtuza ($42,000)," said Tim Horn, FPC chair, "the WAC [annual] price of $27,540 set for Dovato ushers in some much-needed sanity in drug pricing for highly effective, well-tolerated, and easy-to-take HIV treatment."
But Hill has a different take. "There was no improvement in either efficacy or safety for Dovato in the GEMINI trials," he says. "So why should the price be so high? People could take generic TDF, 3TC, and a third drug for a much lower price." (For example, a combo of the Truvada lookalike Cimduo (lamivudine/tenofovir disoproxil fumarate) plus a generic of nevirapine, a longstanding HIV drug, would run insurers about $1,500 a month.)
And Dovato, like Juluca, will almost certainly be priced dramatically lower in other rich countries than it is in the U.S. The drug comes at a time when more than two dozen highly effective HIV regimens are available and drugmakers are constantly trying to tweak medications and extend patents to maintain market share, but when much of the conversation in Congress, among activists, and with the public has shifted to the high price of all medications in the U.S. compared to other wealthy countries.
In the past decade or so, new drugs for HIV and hepatitis C have drawn outrage for their unprecedentedly high prices. (Newer, highly effective hep C meds, for example, cost roughly $27,000 to $95,000 for a course of treatment.) Drugmakers have generally been able to offer patients rebates, discounts, and other forms of patient assistance so that they can access the drugs, but, particularly in recent years, that has not quelled growing outrage over the underlying high prices set by drugmakers, without transparency about how prices are determined.
The high prices have put the squeeze on Medicaid programs, moving some of them to hold off on patients whose disease is not advanced.
There is growing support for a proposal from independent senator and 2020 Democrat presidential candidate Bernie Sanders to revoke drugmakers' patent protections if they don't dramatically lower drug prices to the levels of other rich countries -- roughly, about a third.
And back in the HIV realm, there is now increased pressure on the Centers for Disease Control and Prevention (CDC) to make drug giant Gilead lower its roughly $2,000 monthly U.S. price tag on Truvada (used for the preventive regimen PrEP) now that it has been revealed that the CDC actually owns the drug's patents, which it has enforced in other countries, if not against Gilead right here at home.
In other words, Dovato may seem to be priced reasonably for a (not-so) new drug given the existing landscape of super-high HIV drug prices, but its price is consistent with HIV drug costs wildly higher than in other developed nations. And only continued pressure on the U.S. drug pricing system itself from citizens and Congress -- certainly not the good-heartedness of HIV drugmakers like ViiV -- is going to really change that.