About IDVYNSO

What is IDVYNSO?

IDVYNSO is a complete, 1-pill, once-a-day prescription medicine used to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults. It is used to replace a person’s current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). IDVYNSO contains the prescription medicines doravirine and islatravir.

IDVYNSO was shown to be just as effective at keeping people undetectable as other oral HIV treatments – including Biktarvy®.*

In two clinical trials of randomly grouped adults, IDVYNSO was studied to see if it worked as well as other oral HIV treatments (a non-inferiority trial). The trials included adults whose HIV was already undetectable (HIV RNA less than 50 copies/mL) for at least 3 months, who had never failed on any prior HIV treatment, and who had no known drug resistance to doravirine, one of the medicines in IDVYNSO. Out of 1,064 adults who participated, 708 adults were switched to IDVYNSO.

At 48 weeks:

Study 1

vs different oral HIV treatments†

  • 96% (350 of 366) of people who were switched to IDVYNSO stayed undetectable
  • 92% (170 of 185) who continued to take their current oral HIV treatment stayed undetectable

Study 2

vs Biktarvy‡

  • 92% (313 of 342) of people who were switched to IDVYNSO stayed undetectable
  • 94% (161 of 171) who continued taking Biktarvy stayed undetectable

*Biktarvy is a registered trademark of Gilead Sciences Ireland UC.

†Study 1: Treatment at enrollment included 64% of participants on oral integrase strand transfer inhibitor (INSTI)-based regimens, 5% on protease inhibitor (PI)-based regimens (including combinations with INSTI), and 30% on other oral antiviral treatment regimens.


‡Study 2: Treatment at enrollment included Biktarvy.

What are the most common side effects of IDVYNSO?

In these two studies, most people experienced mild to moderate side effects. The most common side effects of IDVYNSO were:

  • Diarrhea
  • Dizziness
  • Tiredness
  • Stomach (abdominal) bloating
  • Headache
  • Weight gain

Minimal weight changes were seen after taking IDVYNSO. At 48 weeks, in study 1, adults taking IDVYNSO gained an average of 2 lbs vs people in the other group who lost 0.3 lbs. In Study 2, people taking IDVYNSO lost 0.6 lbs vs adults in the other group who gained about 0.6 lbs.

IDVYNSO may cause serious side effects, including:

Severe skin reactions. Call your healthcare provider right away if you develop a rash during treatment with IDVYNSO. Stop taking IDVYNSO and get medical help right away if you develop a painful rash with any of the following symptoms: fever, blisters or sores in the mouth, blisters or peeling of the skin, swelling of the face or lymph nodes, feeling tired or generally ill, or redness or swelling of the eyes (conjunctivitis).

These are not all of the possible side effects of IDVYNSO. Call your healthcare provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

IDVYNSO can be taken with many prescription and over-the-counter medicines*

  • Hepatitis C antivirals (elbasvir, grazoprevir, ledipasvir, and sofosbuvir)†
  • GERD (pantoprazole)
  • Seizures (midazolam)†
  • Antifungal (ketoconazole)†
  • Antacids (containing aluminum hydroxide/magnesium hydroxide and simethicone)†
  • Oral contraceptives (containing ethinyl estradiol and levonorgestrel)
  • High cholesterol (atorvastatin)
  • Diabetes (metformin)
  • Opioids (methadone)

*Studies showed IDVYNSO and these medications did not affect each other in how they work.

†Taking IDVYNSO with these medications is not expected to change how any of them work because of the way your body processes IDVYNSO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, and any new medicines you plan on taking, as some medicines may interact with IDVYNSO.

Do not take IDVYNSO if you take certain medicines that are strong CYP3A inducers, lamivudine, or emtricitabine as they can make IDVYNSO less effective.

These medicines can make IDVYNSO less effective. Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are CYP3A inducers. If you have taken any of these medicines in the past 4 weeks, talk to your healthcare provider or pharmacist before starting treatment with IDVYNSO.

What is IDVYNSO?

IDVYNSO is a complete, 1-pill, once-a-day prescription medicine used to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults. It is used to replace a person’s current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

 

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). 

IDVYNSO contains the prescription medicines doravirine and islatravir.

Important Safety Information

Do not take IDVYNSO if you take certain medicines that are strong CYP3A inducers, lamivudine, or emtricitabine as they can make IDVYNSO less effective.

 

Talk to your healthcare provider or pharmacist if you are not sure if any of your medicines are CYP3A inducers. If you have taken any of these medicines in the past 4 weeks, talk to them before starting IDVYNSO.

 

Before taking IDVYNSO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have liver or kidney problems, or ever had hepatitis B virus infection.
  • Are pregnant or plan to become pregnant. It is not known if IDVYNSO can harm your unborn baby. Tell them if you become pregnant while taking IDVYNSO.
  • Are breastfeeding (nursing) or plan to breastfeed. It is not known if IDVYNSO passes into your breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment with IDVYNSO: The HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection, the HIV-1 virus may become harder to treat if your baby has HIV-1 infection, and your baby may get side effects from IDVYNSO.
  • Take medicines in addition to your HIV medicine. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
    • Some medicines interact with IDVYNSO. Keep a list of your medicines to show your healthcare provider and pharmacist. You can also ask your healthcare provider for a list of medicines that interact with IDVYNSO.
    • Tell your healthcare provider if you have taken rifabutin in the past 4 weeks.
    • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take IDVYNSO with other medicines.

 

What are the possible side effects of IDVYNSO?

 

IDVYNSO may cause serious side effects, including:

 

Severe skin reactions. Call your healthcare provider right away if you develop a rash during treatment with IDVYNSO. Stop taking IDVYNSO and get medical help right away if you develop a painful rash with any of the following symptoms: fever, blisters or sores in the mouth, blisters or peeling of the skin, swelling of the face or lymph nodes, feeling tired or generally ill, or redness or swelling of the eyes (conjunctivitis).

 

The most common side effects of IDVYNSO include: diarrhea, dizziness, tiredness, stomach (abdominal) bloating, headache and weight gain.

 

These are not all of the possible side effects of IDVYNSO. Call your doctor for medical advice about side effects.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please read the accompanying Patient Information for IDVYNSO and discuss it with your healthcare provider. The physician Prescribing Information also is available.

 

What is IDVYNSO?
Important Safety Information

IDVYNSO is a complete, 1-pill, once-a-day prescription medicine used to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults. It is used to replace a person’s current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

 

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). 

IDVYNSO contains the prescription medicines doravirine and islatravir.

Important Safety Information

Do not take IDVYNSO if you take certain medicines that are strong CYP3A inducers, lamivudine, or emtricitabine as they can make IDVYNSO less effective.

 

Talk to your healthcare provider or pharmacist if you are not sure if any of your medicines are CYP3A inducers. If you have taken any of these medicines in the past 4 weeks, talk to them before starting IDVYNSO.

 

Before taking IDVYNSO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have liver or kidney problems, or ever had hepatitis B virus infection.
  • Are pregnant or plan to become pregnant. It is not known if IDVYNSO can harm your unborn baby. Tell them if you become pregnant while taking IDVYNSO.
  • Are breastfeeding (nursing) or plan to breastfeed. It is not known if IDVYNSO passes into your breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment with IDVYNSO: The HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection, the HIV-1 virus may become harder to treat if your baby has HIV-1 infection, and your baby may get side effects from IDVYNSO.
  • Take medicines in addition to your HIV medicine. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
    • Some medicines interact with IDVYNSO. Keep a list of your medicines to show your healthcare provider and pharmacist. You can also ask your healthcare provider for a list of medicines that interact with IDVYNSO.
    • Tell your healthcare provider if you have taken rifabutin in the past 4 weeks.
    • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take IDVYNSO with other medicines.

 

What are the possible side effects of IDVYNSO?

 

IDVYNSO may cause serious side effects, including:

 

Severe skin reactions. Call your healthcare provider right away if you develop a rash during treatment with IDVYNSO. Stop taking IDVYNSO and get medical help right away if you develop a painful rash with any of the following symptoms: fever, blisters or sores in the mouth, blisters or peeling of the skin, swelling of the face or lymph nodes, feeling tired or generally ill, or redness or swelling of the eyes (conjunctivitis).

 

The most common side effects of IDVYNSO include: diarrhea, dizziness, tiredness, stomach (abdominal) bloating, headache and weight gain.

 

These are not all of the possible side effects of IDVYNSO. Call your doctor for medical advice about side effects.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please read the accompanying Patient Information for IDVYNSO and discuss it with your healthcare provider. The physician Prescribing Information also is available.