How Many Pills Do Hiv Patients Take A Day – Integrase inhibitors—potent antiretrovirals that quickly and powerfully suppress HIV—have allowed HIV researchers and doctors to explore dosing regimens that include as few as three or four drugs. Proponents of dual therapy say effective regimens that include fewer drugs will lower costs, reduce pill burdens and reduce the potential for drug interactions and side effects. But is it that simple?
“Dual-drug regimens are exciting,” says Monica Gandhi, MD, MPH, medical director of Ward 86’s HIV clinic at San Francisco General Hospital and co-chair of the Division of HIV, Infectious Diseases and Global Medicine at UCSF. “But there are many doctors who have been treating HIV for a long time who are a little afraid of the hype of the drug. We are not yet ready to come up with a drug regimen for everyone. “
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“In general, less medication is better,” says Keith Henry, MD, of Hennepin County Medical Center. “I like the philosophy of using a few drugs, but I’m not sure it will be very useful. There may be rare or subtle clinical benefits to a two- and three-drug strategy that are evident over time—which we don’t have. In the United States, many people on the standard three-drug regimen are now using one of the simpler and safer regimens available. .
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Currently, there is only one recommended two-drug regimen for people living with HIV, but the future may bring more. Here is an overview of the current challenges and options, as well as an overview of two other combinations currently being tested.
Dolutegravir (an integrase inhibitor) and rilpivirine (NNRTI) are the only two-drug regimen recommended by the US Department of Health and Human Services (DHHS). These medications can be purchased separately (there are no generic versions available in the United States), so some people on this regimen take two pills once a day. This combination is also formulated as one tablet under the brand name Juluca, which is one pill taken once a day.
This combination of two drugs is not recommended for people who are just starting antiretroviral therapy – it is the only switching option for people who have been virally suppressed for at least six months.
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Gandhi said that in Ward 86, the HIV clinic at San Francisco General Hospital, very few people take Juluca or dolutegravir and rilpivirine. The combination was studied only in patients without a history of virological failure, which is unusual among those treated for HIV in Ward 86. Moreover, the risk of drug resistance, and the need for food security, make this regimen only suitable for people who are very adherent to their medication – and Ward 86 sees many patients are unstable in housing, have financial difficulties or other life problems that can stand in the way of perfect adherence.
“The concern about drug regimens and starting patients on this regimen is that if you lose something like dolutegravir [drug resistance], that can make it very difficult in the future in terms of treatment options,” Gandhi said. “I think that Juluca is very interesting, but it can be more for those who do not have failure in their previous diet and are very compatible. It is not for everyone,” he said.
Another problem is that Juluca—a new drug approved in November 2017—is very expensive, and the convenience of a full tablet regimen can be offset by the high cost. Henry from Hennepin County Medical Center said at his hospital pharmacy, Juluca can cost more than $38,000 a year. (The cost of acquiring the store is approximately $31,000/year.)
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“If we buy the pills separately, it’s hundreds of dollars a month cheaper than that. If you look at what’s happening in society in general health care, we need to always have good resource management,” he said. “If you have a small pill that’s well tolerated, I’m not sure you should always go with one pill.”
Dolutegravir plus lamivudine (3TC) is a promising two-drug regimen currently under investigation. (Not yet approved or recommended for use by the U.S. DHHS.) A generic version of lamivudine is available in the United States.
At the 2018 AIDS conference in July, Pedro Cahn, MD presented the results of the GEMINI-1 and GEMINI-2 studies comparing dolutegravir/lamivudine to a three-drug regimen of dolutegravir/tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) ). The study enrolled treatment-naïve individuals who had not started antiretroviral therapy, with no evidence of drug resistance.
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The researchers compared the percentage of people who achieved viral suppression after 48 weeks between the two treatment groups, in addition to differences in CD4 count gains, adverse events and other safety and tolerability data.
In general, the study showed that the regimen of two drugs is not inferior to the regimen of three drugs: 93% of participants in the regimen of two drugs and 94% of participants in the regimen of three drugs achieved virological suppression in 48. weeks.
There were drug-related adverse events with the two-drug regimen, and the two-drug regimen was also associated with better renal and bone outcomes.
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“As you know, ART today means lifelong therapy,” Cahn said. “So as much as we can do to reduce the drug burden on our patients is very acceptable in terms of long-term toxicity.”
Henry said it will be interesting to see, as the efficacy data becomes available, what the difference is between dolutegravir combined with lamivudine versus rilpivirine. He also plans to monitor costs, and says this will continue to be a concern for patients and providers.
“That’s part of the confusion of our health care system now—and we’re going to continue to have more problems as time goes on and as we have more options for dual drugs and generics available. What are the real benefits of a one-pill supplement compared to two or three generic, cheaper pills? If another pill is 5% or 10% better tolerated or effective, but 45% to 50% more expensive, does a cost analysis support the use of the brand-name drug? We haven’t gotten into this as much as we should, but the overall health care funding situation means we need to be more cost-effective.”
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Perhaps the most interesting drug regimen currently being tested is a long-acting formulation of rilpivirine and cabotegravir (an experimental integrase inhibitor). Dosing regimens currently being tested free people from taking daily oral antiretrovirals. Instead, people receive a long-acting injection once every four weeks or once every eight weeks.
So far, the results of the LATTE-2 study, which tested this formulation, are very promising. The injectable drugs cabotegravir and rilpivirine kept viral load suppressed in 94% of those who received injections every eight weeks and in 87% of those who received injections every four weeks, when measured at 96 weeks. Injectors report high levels of satisfaction and ease with the regimen, and also express a willingness and desire to continue with this drug regimen.
If a longer-acting injection comes to market, Gandhi said he believes it could be useful for people who struggle to take their medication every day — in addition to people who are highly adherent (the bimodal population).
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“We have many patients in Ward 86 who are unable to take daily medication in their lifestyle, but who are seen regularly at the clinic. Homeless people may not show up for primary care visits, but they show up for acute care visits. They are very involved in the clinic, which gives us hope that this will be a therapeutic opportunity.”
Are you interested in learning more about antiretrovirals that have been effective for HIV? It summarizes Liz Highleyman’s LATTE-2 study, which provides in-depth information on how cabotegravir and rilpivirine maintain viral suppression, vaccine-related adverse events, and more.
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In , health navigators guide people to HIV care and trauma-informed support and help access HIV medications and benefits.
Here’s the science behind this exciting new treatment, as well as an overview of early infection and resistance mutations. Sometimes people who are newly diagnosed with HIV ask me when they should start taking HIV medication. If you are living with HIV, you may have heard that it is better to start antiretroviral therapy (ART) as soon as possible. Untreated HIV is more toxic to your body than HIV medication, so I always advise people to start HIV treatment right away.
But some people may be wary of starting HIV medication early. They may not trust providers or government agencies making medical recommendations. They may worry that the “medical establishment” is downplaying the toxicity of HIV drugs so that drug companies and unscrupulous doctors can make more money.
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I have heard these concerns and know that as medical providers, we don’t always do a good job of listening to our patients and addressing their concerns. People who existed historically
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