Dovato is a combination medication that has been FDA-approved for the treatment of HIV since 2019. It consists of two drugs, dolutegravir (DTG, known by the brand name Tivicay) and lamivudine (3TC, known by the brand name Epivir).
The 3TC component of Dovato is one of the oldest HIV medications still in use, being on the market for fighting HIV since 1995. DTG was initially approved by the FDA in 2013 and, a year later, combined with 3TC and abacavir (ABC, Ziagen) in a pill brand-named Triumeq.
To keep it simple, think of Dovato as Triumeq, but without the ABC component. You can refer to our Triumeq drug page to get some additional information about that three-drug regimen.
How Is Dovato Different From Other Single-Tablet Regimens Used to Fight HIV?
Dovato is the newest single-tablet regimen (STR) to be recommended within official U.S. HIV treatment guidelines as an initial combination antiretroviral treatment (ARV) regimen for people who are ARV-naive (i.e., have never been on HIV meds before). Given that it contains just two medications, it represents a simplifying of HIV treatment as we know it—and a step forward in reducing not only medication burden but also potential side effects in an effective ARV regimen.
The 3TC in Dovato is a medication that has been around a long time, incorporated into many different combination ARV regimens, including the older and largely obsolete combination tablets Combivir and Trizivir. Overall, 3TC has always been well tolerated, with few if any specific side effects noted.
Because of its consistent use as part of HIV treatment plans for the past few decades, however, issues have arisen with resistance that sometimes renders 3TC ineffective unless combined with other potent medications that work at different stages of the HIV life cycle.
Similarly, while 3TC is known for having activity against hepatitis B, there have also been issues with resistance developing with this virus as well. So if you have hepatitis B, you want to make sure 3TC is combined with something like tenofovir disoproxil fumarate (TDF, Viread) or tenofovir alafenamide (TAF), which both have more potent activity against hepatitis B. Since Dovato does not have either TDF or TAF in it, Dovato may not be recommended for individuals who also have chronic, active hepatitis B unless added with another medication that is active against hepatitis B.
The other component of Dovato, DTG, as a member of the class of HIV medications called integrase strand transfer inhibitors (INSTI), has often been referred to as the “workhorse” of many HIV treatment combinations. This is because it is a very potent medication that stops HIV from making copies of itself and has a higher genetic barrier to resistance than many other HIV medications, even other INSTI medications such as Vitekta (elvitegravir) and Isentress (raltegravir).
The big question about DTG was whether it could handle the majority of the workload in slowing down HIV replication if combined with only one other medication instead of two.
Does Dovato Work as Well as Three-Drug HIV Treatment Regimens?
The short answer to that question is yes—at least for people living with HIV who have not taken ARVs before.
In the landmark GEMINI 1 and 2 studies, Dovato was compared with the popular three-drug regimen of DTG + TDF + FTC (emtricitabine, Emtriva). Through 96 weeks, Dovato was just as effective in maintaining viral suppression as the three-drug regimen, with no cases of resistance.
Additionally, we have more recent data demonstrating that in people living with HIV who switched to Dovato from a three-drug regimen that included TAF, it was equally effective in maintaining viral suppression 96 weeks after switching when compared to those patients who stayed on the old three-drug regimen.
While these studies demonstrate early and/or recent findings, they are revolutionary in how they can potentially change the landscape of HIV treatment moving forward. Initially, it was thought that individuals living with HIV who are treatment-naive would be the only candidates for a two-drug, one-pill approach like Dovato. And in fact, this is what the current guidelines suggest, putting additional conditions upon using Dovato as an initial combination regimen:
“Dolutegravir/lamivudine (AI)—except for individuals with HIV RNA >500,000 copies/mL, HBV co-infection, or in whom ART is to be started before the results of HIV genotypic resistance testing for reverse transcriptase or HBV testing are available.”
In other words, while these studies are convincing, the trials were conducted among patients who all had HIV viral loads below 500,000 copies/mL, so we don’t know if Dovato will work as well in patients whose viral loads are much higher.
Additionally, guidelines recommend that clinicians ensure that patients they plan to start on Dovato are hepatitis-B negative, as the 3TC component in Dovato may not be enough on its own to treat hepatitis B without worries of resistance.
Finally, clinicians should not prescribe Dovato in patients for whom they have not or cannot do resistance testing before starting treatment. The logic behind this is that since you are treating HIV with only two medications in Dovato, and since resistance to 3TC is relatively common, you want to make sure both medications will work. While DTG is a very durable medication with a high genetic barrier to HIV resistance, using it in Dovato when a person’s HIV may be resistant to 3TC would be like simply treating HIV with DTG on its own—which is not only scientifically unproven but also bordering on unethical in this day and age.
DTG may be durable as hell, but the risk of resistance cannot be discounted, as some case reports have demonstrated.
How to Take Dovato
Dovato is FDA-approved in the United States to be taken once daily, with or without food. Food does not impact absorption of either medication, but some may find that taking Dovato with food is easier on the stomach.
How Much Does Dovato Cost in the U.S.?
Dovato is dosed at DTG 50 mg/3TC 300 mg, with a cost approximated at $2,295 for a month’s supply.
While Tivicay and generic 3TC can be used together, there is no generic version of Dovato, so if you have health insurance, monthly copays for Dovato can typically run between $50 and $100, depending on the plan.
You should always check to see if your insurance can do a three-month supply, which may reduce the cost more. Additionally, you may qualify for cost-sharing assistance provided by the manufacturer.
If you don’t have insurance, or your insurance won’t cover the majority of Dovato’s cost (you are “underinsured”), there is a patient assistance program that can help reduce or eliminate the cost, depending on your financial situation.
Side Effects of Dovato
As with all the current ARV regimens, there is the potential for mild side effects, particularly when first starting out on meds or switching to Dovato. Symptoms like an upset stomach, mild rash, nausea, or diarrhea may happen, which may be related to the coating on the outside of the pills rather than the medication itself.
A general rule of thumb is what we call “the two-week rule”—when starting your HIV treatment regimen, give your body about two weeks for it to get adjusted to the medication. Sometimes rashes, mild fever, joint pain, or other symptoms may happen, and this could be related to the medication working and your immune system getting stronger as a result—manifesting as these symptoms. Keep in touch with your medical team and let them know as you move forward.
If, however, after a couple of weeks, you are still having bothersome symptoms or they are progressing, let someone from your medical team know so that you can schedule a virtual or in-person meeting to discuss. In this day and age, we have varying options for HIV treatment, and it is possible that even if a medication worked well for one of your friends, that doesn’t necessarily mean that your body will respond to it in the same way. Speak up, let your provider know, and discuss whether they recommend labs or switching up your regimen altogether.
As mentioned in our Triumeq drug info page, it is important to consider the potential side effects of DTG and 3TC separately.
3TC has been well tolerated by countless patients for decades, with few reports of serious side effects. Fears of lactic acidosis and other rare side effects were learned to be more associated with older HIV medications than with 3TC, hence why it has stayed around for so long. The main concern for many with 3TC is not necessarily the potential side effects, but the potential for resistance to both HIV and hepatitis B.
With the DTG component of Dovato, a few potential side effects should be noted. First, there have been reports of an increased likelihood of neuropsychiatric side effects such as sleep disturbances or mood issues. Most of these have been case reports and smaller studies with very specific populations. A review of double-blind, randomized, controlled trials with these side effects of DTG noted they did exist, but with a low frequency, and they rarely caused people to stop taking the medication.
Additionally, there were also early reports of neural tube defects among newborns of pregnant women on DTG, but these early reports have been refuted in subsequent studies not noting an association.
Finally, an emerging side effect concern that has come up with DTG in Dovato has been weight gain. Although data is still emerging, early reports suggest that patients are experiencing some weight gain when on DTG-inclusive regimens, including Dovato, though not in excess of what folks are seeing while on other HIV regimens that include an INSTI-class medication.
In the future, medical and general communities will learn more about the patterns and locations of this weight gain and its clinical significance in patients’ everyday lives. For now, however, it’s something that patients, clinicians, and our medical teams should be paying attention to as we have more people taking INSTI-containing regimens like Dovato.
While the side effect of weight gain may not seem challenging compared to the more drastic side effects of older HIV medications, there is much we still don’t know. Discussions of both medical concerns of weight gain as well as cosmetic concerns should be part of our review of side effects when patients are on Dovato.
Interactions Between Dovato and Other Drugs
Like Triumeq, Dovato is an STR that does not have a boosting medication in it (e.g., cobicistat or ritonavir); thus, it doesn’t have too much in the way of drug interactions with which to be concerned. Moreover, one of the benefits that many see in choosing Dovato as an STR to treat HIV is that it doesn’t contain any of the tenofovir products on the market, TDF or TAF, that have the potential of kidney and bone loss issues. Thus, kidney monitoring while on Dovato, while a part of routine check-ups while on ARVs, does not hold the same concern of kidney toxicity as with other regimens that contain TDF in particular.
What’s the Verdict on Dovato?
Early studies support that Dovato can be a good option for certain patients living with HIV who are either ARV-naive and first starting therapy, or for some who may be switching from a three-drug regimen and wanting to avoid any potential side effects related to tenofovir or abacavir.
Consider it a sexier version of Triumeq but without the ABC, so you don’t have to go through additional blood testing before starting the medication to ensure you aren’t predisposed to an allergic reaction or worry about the association of ABC with heart disease.
While it still is early in Dovato’s career as an ARV regimen option, remember that studies suggest it is best used for patients who are ARV-naive and:
- Have a viral load below 500,000 copies/mL
- Do not have hepatitis B
- Have a genotype resistance profile available to make sure of no resistance to 3TC
Dovato has the potential to be a real game changer in HIV therapy moving forward: It’s the first two-drug regimen recommended for ARV-naive patients as an initial treatment option. Side effects appear to be minimal, aside from the weight gain we know exists with DTG treatment regimens, and early studies suggest that patients can safely switch from a three-drug regimen to Dovato and still maintain viral suppression.
Time will tell, but it looks like there is a new kid on the block when it comes to HIV treatment options—and we should be open as clinicians and patients to discussing it as a treatment option moving forward.