Genvoya for HIV Treatment: Everything You Need to Know

Genvoya is a combination medication consisting of four drugs that has been FDA-approved for the treatment of HIV since 2015. The four drugs contained within a Genvoya pill are:

• Cobicistat (COBI; brand name: Tybost)
• Elvitegravir (EVG; former brand name: Vitekta)
• Emtricitabine (FTC; brand name: Emtriva)
• Tenofovir alafenamide (TAF; no brand name)

The emtricitabine (FTC) component of Genvoya has been on the market since 2003. Tenofovir alafenamide (TAF) hadn’t been approved previously; it made its debut as a component of Genvoya. Elvitegravir (EVG) was first approved as a component of the single-tablet regimen (STR) Stribild in 2012 and then as a stand-alone option as Vitekta in 2014; Vitekta was discontinued just two years later, and EVG is now available only as a component of Stribild and Genvoya.

Cobicistat (COBI), also known as “Tybost,” has been around since 2014, combined separately with Prezista or Reyataz as Prezcobix and Evotaz, respectively, and is also part of the STR called Stribild. COBI is not active against HIV, but rather works as a boosting agent—it blocks a protein in the liver that processes EVG, increasing its drug levels in the blood so that it can be taken once daily.

What Is the Difference Between Genvoya and Stribild?

Genvoya is basically the updated version of Stribild, an STR approved by the FDA in 2012 that contains EVG, FTC, COBI, and tenofovir disoproxil fumarate (TDF, Viread). Genvoya swaps out the TDF for TAF; it has been found in clinical trials that TAF is less likely than TDF to affect markers of kidney and bone function and that Genvoya is just as effective in achieving viral suppression as Stribild.

Hence, for people who had been taking Stribild since 2012, clinicians began switching them over to Genvoya starting in 2015—as it was just as effective, had less potential for kidney and bone toxicity, and was packaged in a smaller pill.

There are also studies that show Genvoya’s effectiveness in maintaining viral suppression in the setting of existing HIV resistance in highly treatment-experienced patients and when switching from another regimen.

As with any STR that includes TAF and FTC, one of the benefits of being on Genvoya is that not only is it effective in slowing down HIV, it is also useful in the treatment of hepatitis B. Both FTC and TAF, the two NRTIs in Genvoya, 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 Genvoya 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.

How Strongly Is Genvoya Recommended for HIV Treatment?

For several years, Genvoya had been a recommended initial combination antiretroviral treatment (ARV) regimen within official U.S. HIV treatment guidelines for people who are ARV-naive (i.e., have never been on HIV meds before). In recent years, however, Genvoya has been demoted to an alternative regimen, particularly for patients living with HIV who are new to HIV treatment.

This is primarily due to known issues with a lower genetic barrier to resistance than newer INSTI medications like bictegravir, which is part of Biktarvy, and dolutegravir (a.k.a. Tivicay), which is part of Dovato. It is also because Genvoya has to be formulated in an STR that includes the “boosting” medication COBI, which can cause drug interactions for people who are on other medications.

Moreover, Genvoya is not recommended for women living with HIV who are of child-bearing age, as drug concentrations are suboptimal during the second and third trimesters of pregnancy.

How to Take Genvoya

Genvoya is FDA-approved in the United States to be taken once daily, preferably with food, as food may help improve absorption of the medications.

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

Genvoya is dosed at 150 mg EVG, 150 mg COBI, 200 mg FTC, and 10 mg TAF, with a cost approximated to be about $3,202.66 for a month’s supply.

There is no generic version of Genvoya 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 Genvoya 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 Genvoya’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 Genvoya

Possible Initial Symptoms After Starting Genvoya

As with many ARV regimens, there is the potential for mild side effects, particularly when first starting out on meds or switching to Genvoya. Symptoms like an upset stomach, mild rash, nausea, or diarrhea may happen.

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.

Other Possible Issues With Genvoya: Cholesterol, Creatinine, and Weight Gain

Genvoya is well-tolerated by most people, and you don’t hear much about people having side effects while on it. Aside from initial possible symptoms, however, there are a few other potential issues that may occur.

Higher cholesterol levels have been noted with Genvoya compared with Stribild in clinical trials, but it is thought that this may be due to the presence of TAF, instead of just due to EVG.

Another issue to pay attention to is the potential for elevations in creatinine in the blood, due to COBI’s blocking of the kidneys’ ability to get rid of it. This potential side effect is known to be reversible and has not been noted to cause significant kidney problems in patients or forced them to stop the medication altogether. Still, for people living with HIV who also have other health conditions that could impact the kidneys (i.e., high blood pressure and/or diabetes), this is something to follow closely.

Finally, an emerging side-effect concern that has come up with Genvoya, as with other ART regimens that contain INSTI medications, has been weight gain. Although data is still emerging, early reports suggest that people are experiencing some weight gain when on STRs that include both an INSTI and TAF, like Genvoya.

Though this weight gain with the EVG in Genvoya may not be as pronounced as with the more durable INSTI medications like bictegravir (in Biktarvy) and dolutegravir (in Triumeq), it is a real dynamic happening with some people, and this may be challenging for clinicians who are trying to figure out if the weight gain is due to EVG, TAF, or the combination of the two together.

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 their medical teams should be paying attention to as more people begin taking INSTI-containing regimens like Genvoya.

While the side effect of weight gain may not seem clinically significant compared to the more drastic side effects of older HIV medications, there is much we still don’t know. Discussions of both the medical and cosmetic concerns of this weight gain should be part of our review of side effects when patients are on Genvoya.

Interactions Between Genvoya and Other Drugs

Genvoya is an STR that contains COBI as a boosting medication, which allows EVG to work more effectively and stay in the bloodstream longer. However, it also has the potential to interact with many other medications.

Remember that COBI blocks one of the proteins in the liver that helps it process and metabolize other drugs. The COBI in Genvoya may cause the levels of many other medications to increase in the body, which could increase the potential for side effects.

Medications likely to be affected include:

• Steroids like fluticasone (typically found in inhalers for asthma and COPD).
• Cholesterol medications like simvastatin.
• Blood pressure medications like certain calcium-channel blockers and beta blockers.
• Some antidepressants.
• St. John’s Wort.

If you are on Genvoya and taking medications for other conditions, make sure your medical providers know about all of the medications you take, in order to help safeguard against potential interactions. The website HIV Drug Interactions, maintained by the University of Liverpool, has a helpful “interaction checker” where you can review potential interactions between medications you are on.

Weighing the Pros and Cons of Genvoya

Genvoya has become a primary option for HIV treatment since its approval in 2015 and has been shown to be a good option for HIV treatment, despite not being recommended as a first-line option anymore in official U.S. guidelines.

Pros:

1. Powerful treatment for managing HIV in a single-tablet regimen.
2. Includes TAF, which may be safer on the bones and kidneys than TDF.
3. Smaller pill than Stribild and some other STRs.

Cons:

1. Has been associated with some mild elevations in cholesterol.
2. Not recommended for women of child-bearing age.
3. Boosting agent COBI can cause multiple drug interactions.
4. Lower genetic barrier to resistance than other INSTI-containing STRs.

What’s the Verdict on Genvoya?

Genvoya, when it was approved in 2015, appeared poised to enjoy a long stay as a preferred initial regimen for people living with HIV. It is a potent INSTI-based regimen that has the advantage of having TAF as a safer alternative to TDF on the bone and kidneys.

As with many of the earlier STRs, however, the advancement of science ushered in the development of STRs containing newer INSTI medications that are more durable, have a higher genetic barrier to resistance, and do not have to be taken with a boosting medication that can interact with many other medications.

There are also concerns with elevations in cholesterol and creatinine in the blood, but the clinical significance of these findings has yet to be fully determined.

Finally, it is not recommended as an HIV regimen if you are or could become pregnant.

To be clear: Genvoya still remains a great option for HIV treatment. But it is an alternate, not a preferred, initial regimen in U.S. guidelines. If you are on Stribild, you can discuss switching to Genvoya with your medical provider for its relatively safer side-effect profile and smaller pill size. If you are currently on Genvoya and are doing well with no side effects or drug interactions—and you are virally suppressed—you should remain on it.

As with all HIV medications, what is good for one person may not be good for another. While it may not be “preferred” by the experts based on recent scientific studies, Genvoya is still a viable treatment option for many living with HIV. And if it is working well for you, that is all that matters.