Is GENVOYA Right for you?

GENVOYA® can help you reach your health goals by improving your immune system. Two important HIV-1 treatment goals are lowering the amount of virus in your blood (viral load) to undetectable and increasing your number of infection fighting CD4 T-cells. Undetectable means your viral load is so low it can't be measured in a lab test (less than 50 copies/mL).

GENVOYA has been proven to be effective in diverse groups of people: ages 12 and older, men and women, and in people of different races/ethnicities.

Viral suppression over the long term in two clinical studies

In clinical studies of the adults who had never taken an HIV-1 treatment before, 84% of people taking GENVOYA were undetectable at 3 years, compared to 80% of people who took another treatment.*


Number of people in study: 1,733
Number of people who took GENVOYA: 866
Number of people who took another HIV-1 treatment*: 867

The decline in the number of people who reached undetectable (less than 50 copies/mL) at 2 and 3 years was mainly due to people dropping out of the study or no longer maintaining an undetectable status.


On average, GENVOYA helped adults new to HIV-1 treatment increase the average number of CD4 T-cells as effectively as the other approved HIV-1 treatment.*



*The other treatment in these studies was STRIBILD® (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate).

CD4 T-cell increases shown in cells/mm3. The average baseline CD4 T-cell count for adults in this study was 427 cells/mm3.

For people replacing their current HIV-1 treatment

In a clinical study, 93% of adults who replaced their HIV-1 treatment with GENVOYA stayed undetectable at 2 years of treatment.

People in the study had an undetectable viral load (less than 50 copies/mL) for 6 months or more on their current HIV-1 treatment. They also had to meet certain other requirements as determined by a healthcare provider in order to replace their current HIV-1 treatments with GENVOYA.


Total people in study: 1,436
Total people who replaced their treatment with GENVOYA: 959
Total people who remained on their current HIV-1 treatment*: 477


GENVOYA worked as well as the other approved treatments. In this study, the difference in the results was largely due to the higher number of people who remained on their current HIV-1 treatment and then dropped out of the study.

On average, GENVOYA helped adults maintain the average number of CD4 T-cells as effectively as the other approved HIV-1 treatments.*



*The other treatments in this study were STRIBILD, ATRIPLA® (efavirenz, emtricitabine, and tenofovir disoproxil fumarate), or TRUVADA® (emtricitabine and tenofovir disoproxil fumarate) + Reyataz (atazanavir) + cobicistat or ritonavir.

CD4 T-cell increases shown in cells/mm3. The average baseline CD4 T-cell count for adults in this study was 705 cells/mm3.


GENVOYA is recommended by the US Department of Health and Human Services (DHHS) as a treatment for adults and adolescents who have never taken HIV-1 medicines before.

If you are thinking about switching to GENVOYA, your healthcare provider must determine that you meet certain requirements, such as being undetectable for 6 months or more on your current medicine.

GENVOYA is recommended by the US Department of Health and Human Services (DHHS) as a treatment for adults and adolescents who have never taken HIV-1 medicines before.

If you are thinking about switching to GENVOYA, your healthcare provider must determine that you meet certain requirements, such as being undetectable for 6 months or more on your current medicine.



Talk to your healthcare provider about what to expect when starting GENVOYA.

Before taking GENVOYA, tell your healthcare provider if you:

  • have or have had any kidney problems
  • have or have had any liver problems, including HBV infection
  • have any other medical conditions

Avoid doing things that can spread HIV-1 infection to other people.

  • Do not share items that can have blood or body fluids on them, like needles, other injection equipment, razor blades or toothbrushes.
  • Always practice safer sex. Use protection, like a latex or polyurethane condom, when having any sexual contact.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about GENVOYA®?

GENVOYA may cause serious side effects:

Who should not take GENVOYA?

Do not take GENVOYA if you take:

What are the other possible side effects of GENVOYA?

Serious side effects of GENVOYA may also include:

The most common side effect of GENVOYA is nausea. Tell your healthcare provider if you have any side effects that bother you or don't go away.

What should I tell my healthcare provider before taking GENVOYA?

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

What is GENVOYA?

GENVOYA is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older who weigh at least 77 pounds. It can either be used in people who are starting HIV-1 treatment and have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. These include having an undetectable viral load (less than 50 copies/mL) for 6 months or more on their current HIV-1 treatment. GENVOYA combines 4 medicines into 1 pill taken once a day with food. GENVOYA is a complete HIV-1 treatment and should not be used with other HIV-1 medicines.

GENVOYA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking GENVOYA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

Please see Important Facts about GENVOYA, including important warnings.