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Genvoya Approved in Canada: What You Need to Know

January 2016

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On November 27, 2015, Health Canada licensed the sale and use of a new anti-HIV treatment sold under the brand name Genvoya and made by the pharmaceutical company Gilead Sciences. Genvoya is a complete treatment in one pill that comes in the form of green capsule-shaped tablets. The dose of Genvoya used by adults with HIV is one tablet once daily with food. Genvoya was generally well tolerated in clinical trials; general and usually temporary side effects included headache, tiredness or lack of energy, nausea and diarrhea. Genvoya should be available for ordering by pharmacies late in January 2016.


Inside Genvoya

Each tablet of Genvoya contains the following medicines:

  • elvitegravir 150 mg -- an integrase inhibitor
  • cobicistat 150 mg -- a boosting agent; cobicistat raises and maintains the level of elvitegravir in the blood so that it can be taken only once a day
  • FTC (emtricitabine) 200 mg -- a nucleoside analogue (nuke) that works against HIV
  • TAF (tenofovir alafenamide) 10 mg -- another nuke that works against HIV

The only new drug listed above is TAF. This is a new formulation of an older drug called tenofovir DF (tenofovir disoproxil fumarate). TAF is meant to eventually replace tenofovir DF. In clinical trials, TAF was found to be safe and generally well tolerated with fewer side effects than tenofovir DF. Further details on side effects appear later in this issue of TreatmentUpdate.

Genvoya is the first pill to be licensed in Canada that contains TAF.


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Studies

In clinical trials (for details, see TreatmentUpdate 211) Genvoya has been tested in more than 3,000 HIV-positive people. Researchers found that Genvoya was an effective regimen against HIV. Genvoya, which contains TAF, was found to be as good as other regimens that contained the older formulation, tenofovir DF. Genvoya was generally well tolerated and safe; because it contains TAF, it has a reduced potential for causing side effects affecting the kidney and bones compared to regimens that include tenofovir DF. Genvoya was effective both in people new to anti-HIV therapy and in those who are treatment-experienced.


Common Side Effects

In clinical trials Genvoya was generally well tolerated. General side effects included the following:

  • headache
  • tiredness or lack of energy
  • nausea
  • diarrhea

These side effects are usually temporary.


Uncommon Side Effects

Fewer than 1% of participants in clinical trials experienced the following side effects:

  • abdominal pain
  • indigestion
  • flatulence
  • rash
  • vomiting


The Kidneys

The kidneys filter blood and then put waste materials into urine and reabsorb nutrients and other useful materials back into the blood.

Genvoya, because it contains cobicistat, can interfere with the ability of the kidneys to release the waste product creatinine into urine. Therefore, a small but persistent increase of creatinine levels in the blood is generally seen in people who use Genvoya. This small increase is not considered harmful and is usually reversible once a person stops taking Genvoya. Furthermore, this particular effect on the kidneys does not appear to affect the ability of these organs to filter other substances. This effect on the kidneys by cobicistat is also seen with the anti-ulcer drug cimetidine (Tagamet) and the anti-HIV drug dolutegravir (Tivicay and in Triumeq).


Lipid Levels

In clinical trials Genvoya users developed small increases in the levels of cholesterol and triglycerides in their blood.


Warnings

1. Lactic Acidosis

Genvoya contains TAF and FTC. Both of these medicines may be associated with a build-up of the waste product lactic acid in the blood. People who are obese or who have used nukes for many years may be at increased risk of developing lactic acidosis. Symptoms of excess amounts of lactic acid in the blood can include the following:

  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • unexpected tiredness
  • unexpected muscle pain
  • feeling cold, especially in the arms and legs
  • feeling dizzy or light-headed

If these symptoms occur while you are taking Genvoya, call your doctor right away.


2. Liver Problems -- Enlarged Liver and Fatty Liver

In rare cases, people who take Genvoya may develop swollen liver (hepatomegaly) or fatty liver (steatosis). Obesity and the use of nukes over many years may be risk factors for enlarged and fatty liver in people with HIV. People who develop these specific liver problems may also develop the following symptoms:

  • yellowing of the skin and whites of the eyes (jaundice)
  • nausea
  • vomiting
  • abdominal pain

If any of these symptoms develop, contact your doctor right away.


3. Other Liver Problems -- Hepatitis Viruses

The safety of Genvoya in people co-infected with HIV and hepatitis B virus (HBV) is not known. Genvoya contains tenofovir (in the form of TAF), which has anti-HBV activity. Co-infected people who take Genvoya and then stop it may notice symptoms of their hepatitis B infection worsen. If you have this co-infection, talk to your doctor before you start Genvoya. If you later need to change your therapy, remind your doctor that you have hepatitis B.

People who are co-infected with HIV and hepatitis-causing viruses (including hepatitis C virus) and who take potent combination anti-HIV therapy (ART) can be at increased risk for liver injury. It is important to have regular blood tests so that your doctor can assess the health of your liver. If lab tests reveal that you do not have hepatitis B, speak to your doctor about getting a vaccine to protect you from it. There is no vaccine for preventing hepatitis C virus infection.


4. Women

In clinical trials with Genvoya, the proportion of women enrolled was relatively small. However, no side effects were more common in women than in men.

Genvoya's safety has not been studied in pregnant women. Gilead Sciences recommends: "Genvoya should not be used in pregnant women unless the potential benefits outweigh the potential risks to the fetus."


5. Emotional Issues -- Anxiety and Depression

Genvoya is similar to another fixed-dose combination treatment called Stribild (the only difference between these pills is that Genvoya contains TAF, and Stribild contains tenofovir DF instead of TAF). After the licensure of Stribild, reports emerged of very rare cases of depression associated with the use of Stribild. Stribild and Genvoya both contain the integrase inhibitor elvitegravir. Note that all integrase inhibitors have been associated with rare cases of anxiety and depression. Whether these drugs caused anxiety or depression is not clear. In some reports, the rare cases of anxiety and/or depression associated with the use of integrase inhibitors occurred mainly in people who had a history of these issues.

Anxiety and depression are relatively common in HIV-positive people (regardless of whether they are on treatment or the type of treatment that they take). If you are taking Genvoya and think that you may have developed anxiety or depression, speak to your doctor right away. Your doctor can help determine if you have anxiety or depression and if there is any relationship between them and the medicines that you are taking.

If you have thoughts of harming yourself or others, dial 911 right away.

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Genvoya, New Single-Tablet HIV Regimen Containing Tenofovir Alafenamide, Approved By FDA
New HIV Treatment Genvoya Is Really All About the TAF Part
What's the Effect of Genvoya, the Newest Single-Tablet Regimen, on Older Adults Living With HIV?



This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication TreatmentUpdate. Visit CATIE's Web site to find out more about their activities, publications and services.
 

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