Four decades after the HIV epidemic began, there’s finally hope it might end. Indeed, “Getting to Zero” — meaning zero new HIV infections — is a slogan used by the World Health Organization and others in fighting the epidemic.
A major factor driving this optimism is pre-exposure prophylaxis, commonly known as PrEP, in which people who are HIV-negative take a medication to prevent HIV infection.
For Gilead Sciences, the manufacturer of the only two FDA-approved pills for PrEP, the most important zeroes seem to be those the company is adding to its bottom line.
It’s a tale of two medicines. In 2012, the FDA approved Gilead’s Truvada for PrEP. Generic versions of Truvada will become available later this year, threatening an important revenue stream for the company. (Of note, Gilead is in a dispute with activists and the U.S. government over PrEP patents.)
Enter Descovy, another PrEP pill from Gilead that the FDA approved in 2019. Generics for Descovy aren’t expected until at least 2022, and possibly 2025. Gilead has been aggressively marketing Descovy for PrEP, including a newly launched ad campaign. We’ve heard research teams — which included Gilead representatives — suggest at scientific conferences that Descovy is not only safer but also possibly more effective than Truvada for PrEP.
If that is true, hundreds of thousands of people in the United States now using Truvada for PrEP should switch to Descovy. Gilead’s CEO is hopeful that will happen, having predicted in January that nearly half of those using Truvada for PrEP will become Descovy users by the end of 2020.
That would undermine the fight against HIV.
Truvada works extremely well. Multiple studies have shown that, taken daily, it provides up to 99% protection against HIV infection in many groups, including gay and bisexual men, transgender women, people who inject drugs, and heterosexuals whose partners are living with HIV. As for safety, no serious harms have been reported among over 200,000 U.S. users of Truvada over the past decade. The data are so convincing that the highly respected U.S. Preventive Services Task Force gave daily PrEP its highest recommendation for use in at-risk populations.
By contrast, there’s been only one study of Descovy for PrEP. That study, called DISCOVER, enrolled gay and bisexual men and some transgender women. It showed that Descovy is as effective as Truvada, but no better than it. (Unfortunately, DISCOVER did not enroll other at-risk populations, for whom its effectiveness as PrEP remains unknown.)
In DISCOVER, both Truvada and Descovy had minimal side effects. Some individuals taking Truvada had marginally decreased kidney function or bone health, and some taking Descovy had slight increases in weight or cholesterol. For only a small minority of individuals — like those with kidney problems or high cholesterol — one or the other medicine would be a more reasonable choice. Both medicines are so safe that California now allows people to get PrEP starter packs from a pharmacist without a prescription.
But what about the cost?
The current list price of Truvada — around $24,000 per year — is one reason that more than half of people in the U.S. who could benefit from PrEP aren’t using it. PrEP uptake is far lower among Black and Hispanic individuals than among white people. Descovy’s list price is the same as Truvada’s, offering no financial relief for people who need access to PrEP.
Assistance programs from Gilead and others can help patients get PrEP at low or even no cost. But accessing those programs, or getting prior authorization from insurers, is so complicated that some clinics now employ PrEP navigators to shepherd patients through the process. And although the U.S. Preventive Services Task Force’s recommendation should eventually waive out-of-pocket costs for PrEP, that just means that private or government insurance programs will be left footing the bill.
That’s why we believe that generic Truvada will be so important. Lower-cost medicines can translate to easier access for those who need PrEP, with cost savings used for other aspects of HIV treatment and prevention. In Australia, the introduction of generic Truvada for only $8 per month was followed by a dramatic reduction in new HIV infections.
Perception is crucial. Hyping Descovy over Truvada for PrEP might lead patients or doctors to hesitate to use Truvada, both the brand-name medication and the generic. That’s not a theoretical concern. Prescriptions for Truvada, approved to treat HIV in 2004, declined substantially in 2016, when Descovy was approved to treat HIV.
There’s no question that having another option for PrEP besides Truvada is a good thing. But when choosing a medication, people should rely on evidence, not advertising. Last month, the New York City Department of Health and Mental Hygiene recommended Truvada as the first-choice medication to help ensure the broadest possible access to PrEP.
“Getting to Zero” in the HIV epidemic is now more possible than ever. Let’s just remember that the zeroes that truly count relate to people, not profits.
Douglas Krakower, M.D., is an infectious disease physician and assistant professor of medicine at Harvard Medical School. Kenneth Katz, M.D., is a dermatologist at Kaiser Permanente San Francisco Medical Center. Julia L. Marcus, Ph.D., is an infectious disease epidemiologist and assistant professor of population medicine at Harvard Medical School. Krakower has conducted research with project support from Gilead Sciences. Marcus has consulted for Kaiser Permanente Northern California on a research grant from Gilead Sciences.
Danny Dixon,
Please access this link and review carefully:
https://aidsinfo.nih.gov/drugs/406/truvada/8/professional
Do you see anything about coronavirus? I don’t think so.
FYI Gilead already has another drug currently being tested globally against coronavirus. It is known as remdesivir. It failed against Ebola a few years agobut now shows some promise. Google it (Gilead and remdesevir) and do some research yourself yourself. Good luck!
Does Truvada, which blocks the HIV virus have any effective block of the coronavirus?
Why not obtain then generic tenfovir (300mg) and emtricitabine (200mg), the make mix them up and make your own combo in the right proportion and dosage, and take them with your doctor’s supervision?
This article is full of so many half truths and falsehoods it is hard to know where to start. Let me start by saying I have no sympathy for corporate greed or for the high prices we pay for drugs in the US. That said, Truvada has been very effective it is true, but touting it as risk free is false. We know that Truvada has caused declining renal function in people with HIV and there is a decline in bone density. For people under the age of 35, who are still creating the bone mass that they will have for life Truvada causes a blunting of the development of that bone mass. While short term there will be no effect we have had to warn people for years that we don’t know what the long-term effects of this blunting of bone mass will have. Will young people develop osteoporosis sooner? No one knows. And for older people the risk of osteoporosis is already high and renal function declines already as part of aging.
Perhaps these providers, all of whom are working for universities or large medical systems , don’t worry about the medicolegal implications of prescribing a drug with more potential side effects, let alone the possible increased risk to patients. How fortunate for them. I don’t want to have to explain to a court why I prescribed a drug with more potential side effects when I knew there was another without that potential after my patient develops renal disease or breaks a bone sooner than expected.
As to cost, I have exactly one patient who pays out of pocket for PrEP—a man who is on Medicare and has way too much money to qualify for assistance. I have no idea what these providers are talking about when they mention difficulties accessing coverage. It took me exactly 10 minutes to sign up for the Advancing Access program and I have never paid a dime for PrEP. PrEP navigators are not there because of the difficulty of accessing coverage. They are there to make sure that patients remain adherent and get the access they need, but it is not difficult. Why the authors have to use scare tactics is beyond me. Another falsehood is the contention that Truvada will cost less when it goes generic. First of all, no one has any idea what it will cost and generics are not always substantially lower in cost. Second, generics will not have a copay assistance program so my patients, all of whom pay nothing out of pocket, could get hit with a big bill. Third, the biggest cost of PrEP is the office visits and labs required for monitoring. Since Descovy is potentially safer than Truvada in the long run, renal monitoring every 3 months is not necessary. That saves money on labs. Perhaps the authors are willing to see their patients for free and provide free labs. I am not aware that Kaiser of Harvard treats any patients for free.
If the authors wish to keep their patients on Truvada no one will stop them. It was 99.4% effective in preventing HIV in the DISCOVER trial and that is great. But there is no reason to force the rest of us who feel more comfortable prescribing Descovy to stop. Nor is there any reason to promote the idea that it is only greed driving this. Every pharma company is greedy–I have no illusions about that. But there are plenty of good reasons why someone might switch to a potentially less toxic drug, a much smaller pill and no increase in cost. And there are a lot of very important reasons why people of color and poor people are not accessing PrEP. Most of that has to do with providers unwilling to prescribe it and lack of access to care. Those are real problems the authors should be addressing.
More PrEP hype. Gilead has captured the scientific discourse by paying researchers. Like Big Tobacco did. Like Big Oil and climate change. Shameful. Almost 100% of JAMA’s articles on PrEP have some sort of Gilead support. Funny how these sorts of market pumping articles never mention that the US is lagging far behind many other countries in Europe and Africa in the proportion of people living with HIV who are virally suppressed. In fact in the US around 30-40% of people are living with HIV but are not on successful treatment and are not virally suppressed–they are at risk of illness, death or transmitting the virus to others (treatment is 100% effective in reducing risk of transmission).
Do not listen to Gilead hype. Treating people living with HIV is the first priority. PrEP and other prevention like condoms will help to further drive us to zero…if we do not increase access to testing and treatment then hundreds of thousands of people will die and tens of thousands will continue to be infected.
People would much prefer a cure then taken pills for HIV I think that they make so much money from selling hiv drugs and not looking to cure hiv they would lose out 💰 they have technology but not enough brains but there soon enough trying work harder on cronavirus but cant seem get rid of hiv virus scientist talk to much about curing hiv and say same stuff they said years ago its a lot of nonsense money should not come in to anything if its saving lifes money mad just cure it and be done with causing hell for people wind ups they really must have the wrong scientist working on job because if there was cure hiv there be lot less discrimination hell health problems that come with it people won’t need see shrink go hospital all time as permanent reminder its been to long to many dead ends asept one man got cured why tell people when it only makes there hopes further away as for pep well again money.