Biktarvy for HIV Treatment: Everything You Need to Know

Biktarvy is a combination medication that is one of the newer single-tablet regimens we have on the market to fight HIV. Biktarvy contains three HIV meds:

• Emtricitabine (FTC), which has been on the market since 2003.
• Tenofovir alafenamide (TAF), which was FDA approved in 2016 in combination with FTC as Descovy, which is used for both HIV treatment and prevention.
• Bictegravir (BIC) is the part of this regimen that sets it apart from many others. The newest INSTI-class HIV medication, approved in 2018, it boasts a much more durable profile against resistance than many other medications in the INSTI class of drugs. (I’ll explain more about what this means in a bit.)

What Makes Biktarvy Stand Out as an HIV Treatment Regimen?

BIC’s resistance profile has led to many medical providers switching patients who had previously been on STRs like Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide), and Stribild (cobicistat/elvitegravir/FTC/tenofovir disoproxil fumarate) to Biktarvy in recent years.

Since 2018, Biktarvy has rapidly established itself as a recommended initial combination antiretroviral treatment (ARV) regimen for patients who are ARV-naive by the Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. In general, studies have shown it to be very well tolerated and just as effective when it comes to viral suppression as other combination HIV treatment regimens.

As with any STR that includes Descovy, one of the benefits of being on Biktarvy is that not only is it effective in slowing down HIV, it is also useful in the treatment of hepatitis B. FTC and TAF, the two medications in Descovy, are effective in combination against hepatitis B.

Having your medical provider check your bloodwork for immunity to hepatitis B (if you have antibodies) or if you may have active hepatitis B will help with this decision. If you do have active hepatitis B, both you and your provider need to know that, as it confirms that Biktarvy will be useful in treating both HIV and hepatitis B. Importantly, it’s also helpful to know this because sometimes when you stop the medication that is treating hepatitis B, you can experience an acute hepatitis B flare.

Bictegravir (BIC), the INSTI component of Biktarvy, is the latest one of its treatment class to gain approval from the FDA. Unlike previous INSTI medications, however, BIC has shown to be very durable for HIV treatment. The virus does not demonstrate resistance to it as much as to other INSTI medications, including raltegravir (Isentress) or elvitegravir (Vitekta). It has a much higher barrier to resistance, similar to dolutegravir (Tivicay), when looking at the major studies examining its effectiveness.

This means that Biktarvy is much more forgiving to the occasional missed dose than some other treatment regimens. While we encourage people living with HIV to always take their medication every day without fail, the truth is that we are all human, and people may miss a dose from time to time.

It is natural to worry about whether the meds will work effectively if we start missing doses—and yes, if you start skipping doses and take your ARV every other day or every third day, it is more likely that you will get resistant to the medications, which will make treating HIV and becoming virally suppressed that much more difficult. You definitely do not want to do that.

However, what makes many confident about Biktarvy is that if you do miss a rare dose and it’s been over 12 hours past when you usually take your medications, don’t panic. It is much less likely with Biktarvy than with some other regimens that you will develop resistance and the meds will stop working.

Biktarvy is the only INSTI-based STR included in the Guidelines recommendations for “rapid start” regimens—HIV treatment that can be started as soon as possible after a diagnosis, before lab results may be available. These lab tests include the detection of possible transmitted HIV drug resistance and potential safety markers (for example, kidney function and a genetic mutation that can increase the risk of side effects to abacavir, one of the drugs in another INSTI-based STR, Triumeq [dolutegravir/abacavir/lamivudine]).

How to Take Biktarvy

Biktarvy is FDA-approved in the United States to be taken once daily, with or without food. Food does not impact absorption of the medication, but some may find that taking Biktarvy with food is easier on the stomach.

How Much Does Biktarvy Cost?

Biktarvy contains 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide. The price is approximately $3,390 for a month’s supply.

There is no generic version of Biktarvy in the U.S. at this point, which can be a deterrent when considering it as an option for HIV treatment.

If you have insurance, monthly copays for Biktarvy can typically run between $50 and $100 depending on the plan, though 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 Biktarvy’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 Biktarvy

As with many ARV regimens, there is the potential for mild side effects, particularly when first starting out on meds or switching to Biktarvy. Mild symptoms may happen, including:

• an upset stomach
• a mild rash
• nausea
• diarrhea

These may be related to the coating on the outside of the pills or 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 feel labs are needed or recommend switching up your regimen altogether.

Potential side effects of concern that have come up with both Biktarvy and other INSTI-class medications are weight gain and elevated cholesterol. Although data is still emerging, early reports suggest that patients are experiencing some weight gain when on Biktarvy, 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 Biktarvy.

While the side effects of weight gain and slightly elevated cholesterol levels 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 medical concerns of weight gain as well as cosmetic concerns should be part of our review of side effects when patients are on Biktarvy.

Interactions Between Biktarvy and Other Drugs

Biktarvy is an STR that does not have a boosting medication in it (such as cobicistat or ritonavir); thus, it doesn’t have too much in the way of drug interactions with which to be concerned.

There may be an interaction with the anti-tuberculosis medication Rifampin, so speak to your medical provider if this is the case.

However, most prescribed and over-the-counter medications do not have significant interactions with Biktarvy and can be taken safely, including gender-affirming hormones for transgender and gender non-conforming persons.

Additionally, because Biktarvy includes TAF, which is relatively safer on markers of kidney health compared with its older formulation TDF, it may be a safe option for people even if they have mild kidney impairment. Make sure you speak to your medical provider to discuss your kidney labs to ensure this is the case.

When to Consider Biktarvy for HIV Treatment

Biktarvy has become a primary option for HIV treatment since its approval in 2018 and has been shown to be equally effective at achieving viral suppression as Triumeq in patients with HIV at 96 weeks of treatment.

Not only has it been proven to be very effective for someone who is first starting HIV treatment, but it also has shown benefit in keeping people virally suppressed when switching from another regimen, even in the setting of some forms of HIV resistance.

There are a few reasons why many consider Biktarvy an important newer HIV treatment option:

1. It is taken once daily, as with other STRs.
2. It doesn’t have to use a “booster” medication (e.g., cobicistat) for better effectiveness, as with medications like Genvoya and Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide).
3. It is a smaller pill than Triumeq and others.
4. It has a higher genetic barrier to resistance than older INSTI medications like elvitegravir and raltegravir.
5. It can still be used in persons who have mild kidney impairment.

What’s the Verdict on Biktarvy?

Biktarvy is one of the newer HIV treatment STRs on the block, but despite only being around for two years, it has become one of the most popular regimens clinicians prescribe, landing it on the preferred list in the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.

It is a potent ARV regimen in a small pill, less likely to impact markers of kidney function compared with previous treatment regimens, and is much more forgiving to the occasional missed dose and less likely to have HIV develop resistance against it.

Biktarvy can be an option both if you are starting HIV medication for the first time or if you are virally suppressed and just want to switch from your current regimen. It’s an excellent choice for HIV treatment, supported by clinical trials, clinicians, and patients alike.

We will need more studies to see if side-effect issues of weight gain and elevated cholesterol are sustained with Biktarvy, and what these mean clinically—for example, whether these effects are associated with an increased risk of cardiovascular disease—for patients who are taking it. In the meantime, we should encourage clinicians to be vigilant with patient follow-up, as usual, but pay particular attention to weight and cholesterol measurements with your patients who are on Biktarvy.

For those of you in the community who are living with HIV and taking Biktarvy, it is likely that you may not have any side effects on Biktarvy, including weight gain. If you notice issues with weight gain, however, speak up with your medical provider and team so that you can discuss what to do moving forward. That way, we can all learn together as we gain more experience with Biktarvy in the real world.