Tivicay (Dolutegravir) for HIV Treatment: Everything You Need to Know

Tivicay (also known by the generic name dolutegravir) is a treatment for HIV taken as one pill once a day in combination with one or more other medications. Tivicay is in a class of drugs called “integrase strand transfer inhibitors” (INSTIs), which stop HIV from making copies of itself.

Tivicay is available as a stand-alone drug. It is also a part of several single-tablet regimens (STRs), or pills that contain multiple HIV meds, including:

• Dovato (dolutegravir/lamivudine)
• Juluca (dolutegravir/rilpivirine)
• Triumeq (abacavir/dolutegravir/lamivudine)

Tivicay is also sometimes prescribed as part of a post-exposure prophylaxis (PEP) regimen in people who very recently had an exposure to HIV. As PEP, Tivicay is usually prescribed along with Truvada (emtricitabine/tenofovir disoproxil fumarate).

How to Take Tivicay

One on hand, the dosing of Tivicay is simple: One pill once a day, without any food restrictions, for most people under most circumstances. On the other hand, you need a bit of a scorecard to keep track of the potential nuances.

Tivicay may be taken with or without food. That said, people on Tivicay who take antacids, laxatives, or certain other medicines (make sure your care provider knows everything you’re taking!) should take Tivicay at least two hours before or six hours after taking these medicines.

For people who take iron or calcium supplements, it’s OK to take such supplements at the same time as Tivicay—but only as long as they take Tivicay with food. If they do not take Tivicay with food, then it’s best to take Tivicay at least two hours before or six hours after taking these supplements.

For most adults, Tivicay comes in a 50 mg tablet. How often it’s taken can vary, however:

• In adults starting their first HIV treatment regimen, or those who have been on treatment before and have undetectable viral load, the Tivicay dose is one pill once a day.
• In adults taking Tivicay with certain other medications that reduce the levels of Tivicay in the body, the Tivicay dose is one pill twice a day.
• The Tivicay dose is also one pill twice a day for those who have been on an INSTI before and have (or may have) certain INSTI resistance mutations in their HIV. (Your doctor will give you the details if any of these conditions applies to you.)

Tivicay also comes in 10 mg tablets and 25 mg tablets for those who require different doses.

Tivicay Dosing for Children

For most children, Tivicay PD comes in a 5 mg tablet that can be swallowed whole by older children, or dissolved in water for younger children. For children 4 weeks or older who weigh at least 6.6 lbs (3 kg), dosing is based on weight:

• For children from 6.6 lbs (3 kg) to less than 13.2 lbs (6 kg), the Tivicay PD dose is one pill once a day.
• For children from 13.2 lbs (6 kg) to less than 22 lbs (10 kg), the dose is three pills once a day.
• For children from 22 lbs (10 kg) to less than 31 lbs (14 kg), the dose is four pills once a day.

Children who weigh 31 lbs or more can take either the adult Tivicay tablet or Tivicay PD tablets. Tivicay and Tivicay PD do not behave the same way in the body, so the number of pills of each differs. Depending on whether children are below 44 lbs (20 kg), or at or above 44 lbs (20 kg), they will need to take anywhere between one and six pills once a day.

How Much Does Tivicay Cost in the U.S.?

The sticker price of Tivicay at the 50 mg dose taken by most adults is about $2,010 for a month’s supply. There is no generic version of Tivicay in the U.S. at this point, which can be a deterrent when considering it as an option for HIV treatment.

If you have health insurance, monthly copays for Tivicay can typically run between $50 and $100, depending on the plan. Check to see if your insurance can provide a three-month supply, which may reduce the cost.

Additionally, you may qualify for cost-sharing assistance provided by the manufacturer. If you don’t have insurance, or your insurance will not cover most of the cost of Tivicay, there is a patient assistance program that can help reduce or eliminate the cost, depending on your financial situation.

Side Effects of Tivicay

As with many antiretroviral (ARV) regimens, there is the potential for mild side effects with Tivicay, particularly when first starting treatment or when switching from a previous regimen to Tivicay. The most common side effects in clinical trials of Tivicay were difficulty sleeping, fatigue, and headache. Tell your medical provider if you develop any side effects.

That said, there are a couple of specific side effects that have been associated with Tivicay that are worth explaining in more detail.

Weight Gain Among People Taking Tivicay

A growing number of studies provide evidence of weight gain among those taking Tivicay. There is a lot of nuance here, and it doesn’t appear to trigger weight gain equally among all people. The Tivicay connection with weight gain is a complex and evolving issue, with a lot of unknowns and much still to be discovered.

If you are on Tivicay or may be starting Tivicay, talk to your doctor about the latest findings on this topic and how they may impact your HIV treatment and your overall health.

Here are the highlights of what we know at the moment:

One major study found that weight gain on Tivicay was more common among people with lower CD4 counts, as well as among those taking Tivicay with Descovy (tenofovir alafenamide/emtricitabine) or Truvada (tenofovir disoproxil fumarate/emtricitabine).

Another major study found that weight gain on Tivicay was more common among people with a lower CD4 count and a higher viral load, as well as among women, Black people, and those who did not use injection drugs.

The same study also found that not only Tivicay, but the entire INSTI class of drugs, led to weight gain more commonly than other HIV drug classes, including protease inhibitors (PIs) and nonnucleoside reverse transcriptase inhibitors (NNRTIs). The study also got into specifics regarding which particular drugs in each class were associated with more weight gain compared to other drugs. On balance, the biggest weight gain culprits were found to be Tivicay, Edurant (rilpivirine), and tenofovir alafenamide (TAF, which is a part of several single-tablet regimens).

The reason we mention some of these other drugs here is that Tivicay is often prescribed alongside them as part of an HIV treatment regimen. Juluca, for instance, is a pill that contains both Tivicay and Edurant. And keep in mind that Tivicay is often prescribed in combination with Descovy, which includes TAF along with another drug, Emtriva (a.k.a. emtricitabine).

In summary: Compared to other HIV drugs, Tivicay is strongly associated with weight gain, and Tivicay is often found in the company of other HIV drugs that are also strongly associated with weight gain.

It is important to note that, while weight gain is a side effect of Tivicay in some people, the jury is still out on whether it is a “bad” side effect, or whether it’s neutral or even beneficial. Weight gain is generally considered a good outcome among people with HIV who are underweight when they first start antiretroviral therapy (ART). But among people with HIV in normal or overweight categories, weight gain may increase the risk of cardiovascular disease (like heart attack and stroke), metabolic disease (like high blood pressure and diabetes), kidney disease, liver disease, and cancer.

Again, if you have any concerns about weight gain on Tivicay, please strike up a conversation about them with your care provider.

Taking Tivicay Before or During Pregnancy

Over the past couple of years, Tivicay has been on a roller coaster when it comes to potential concerns about its use as initial HIV therapy for people who are pregnant or may become pregnant. Although researchers raised a lot of alarm at first, a deeper and longer-term look at the science has determined that these risks are probably extremely low.

In fact, in an update to its mother-to-child HIV prevention guidelines in December 2020, the U.S. health department added Tivicay as a “preferred” HIV medication (its highest recommendation level) for people who are pregnant or trying to conceive.

Most of the pregnancy concerns with Tivicay had to do with certain severe birth defects of the brain and spine, called neural tube defects (NTDs), among infants born to people who were taking Tivicay when they became pregnant. Initially, research appeared to show unusually high rates of NTDs among pregnant people on Tivicay, but these were early studies with a small number of participants. As more research involving more people has come out, it’s become clear that NTD risk with Tivicay is very low. According to one major study, NTDs occurred 0.19% of the time among birth parents who were taking Tivicay at the time of conception and only 0.04% of the time among birth parents who started taking the drug during pregnancy, compared to 0.12% of the time among birth parents who took other HIV medications at conception.

Regardless, not everyone will be comfortable taking Tivicay if they’re pregnant or planning to become pregnant, so if you’re included in that group—or if you can biologically become pregnant, are sexually active, and aren’t using contraception—it’s important to talk about the drug with your medical provider. In fact, it’s a good idea in general for people living with HIV and their care providers to discuss available HIV treatment options in terms of how effective they are, their side effects, their potential to cause birth defects, and individual preferences (number of pills per dose, number of doses per day, food restrictions, etc.). That way, you can make the most informed decision possible about the regimen that’s best for you, whether it includes Tivicay or not.

Interactions Between Tivicay and Other Drugs

Tivicay has relatively few interactions with other commonly used drugs. That said, some medications that speed up the way your body processes other drugs may decrease the amount of Tivicay that’s active against the HIV inside your body. This is why it’s important to make sure your medical provider knows about all the medications you are taking, and supplements as well; they can then tell you whether any drug interactions apply to you. There’s also a useful online tool maintained by the University of Liverpool that can help you quickly assess interaction risks.

The main concern regarding Tivicay involves some over-the-counter products—specifically, certain antacids, laxatives, and ulcer medications, as well as some nutritional supplements—that contain substances called polyvalent cations. Polyvalent cations include aluminum, calcium, iron, magnesium, and zinc. These substances may decrease levels of Tivicay, making Tivicay less effective against HIV, and possibly allowing HIV to become resistant to Tivicay.

Regarding cation-containing medicines or supplements, note the following:

• Tivicay or Tivicay PD should be taken two hours before or six hours after taking cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications.
• When taken with food, Tivicay and supplements containing calcium or iron can be taken at the same time.

When to Consider Tivicay for HIV Treatment

Consider Tivicay if you want a once-a-day regimen that can be taken with or without food. If you want a regimen that is one pill once a day, Tivicay is included in three single-tablet regimens:

• Dovato (dolutegravir/lamivudine)
• Juluca (dolutegravir/rilpivirine)
• Triumeq (abacavir/dolutegravir/lamivudine)

Tivicay can also be used in once-daily regimens that include one additional tablet (i.e., a total of two pills per day rather than one): Tivicay plus Descovy, or Tivicay plus Truvada.

If you are starting your first antiretroviral regimen, any one of these single-tablet or two-pill options may be a good choice for you.

For some people already on HIV treatment, particularly if they have an undetectable viral load, switching from another regimen to a Tivicay-containing regimen may be a way to reduce their number of doses per day, to reduce their number of pills per day, to eliminate a boosting agent (like ritonavir or cobicistat), to eliminate some side effects, or to eliminate some restrictions or requirements around foods or other medications.

Regimens containing Tivicay may also be suitable for those who have experienced treatment failure on a previous regimen or who are at a high risk for missing doses of their HIV treatment regimen. This is because of all the drugs in the INSTI class, Tivicay has what is called a very high “barrier to resistance,” meaning that if you occasionally miss a dose or your HIV already has some resistance to HIV medications, Tivicay can still be effective at keeping viral load down.

What’s the Verdict on Tivicay as Part of an Anti-HIV Treatment Regimen?

Current U.S. guidelines for first-line HIV treatment recommend starting with an INSTI-containing regimen, preferably one that does not need another drug to boost it (like ritonavir or cobicistat) in order to be effective against HIV. The club of INSTIs that do not require boosting is fairly exclusive: bictegravir, Isentress (raltegravir), and Tivicay. Within that small group, as things stand right now, Tivicay offers the most flexibility in terms of recommended regimens, since it is a part of three single-tablet regimens: Dovato, Juluca, and Triumeq.

Tivicay-containing regimens can be an option both if you are starting HIV medication for the first time or if you are virally suppressed and want to switch from your current regimen.

More studies are needed to clarify the issues that have arisen around weight gain; in the meantime, however, Tivicay is a solid cornerstone of a number of treatment regimens that are safe, effective, and convenient for most people living with HIV. Prior concerns regarding Tivicay and pregnancy have been greatly lessened thanks to recent research, but it can still be helpful to talk about Tivicay with a medical provider if you’re pregnant or may become pregnant.

For those of you in the community who are living with HIV and already taking Tivicay, it is likely that you will not have any further side effects on Tivicay, including weight gain. If you do notice weight gain, have any other concerns about side effects, or have any concerns about pregnancy, talk to your medical provider.

Myles Helfand contributed reporting for the pregnancy section of this article.