GENVOYA®
INFORMATION FOR PATIENTS
INFORMATION FOR PATIENTS
PREFACE You have been prescribed GenvoyaÂŽ to treat HIV-infection. This booklet is designed to support you in using Genvoya and to inform you on how it works. This guide is based on the package leaflet supplied with Genvoya1 and should not be used as a replacement. The package leaflet contains the officially approved text. Your doctor, HIV-consulent and pharmacist are the initial contacts for information. If you have any questions after reading this booklet, please remember to contact one of them.
Š Gilead Sciences Netherlands BV This text was composed in 2017 with reference to the official package leaflet. No information contained in this document should be disclosed to others without written authorisation of Gilead SciencesNetherlands BV, Claude Debussylaan 22, 1082 MD Amsterdam.
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GETTING STARTED WITH GENVOYA WHAT IS HIV?
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WHAT IS GENVOYA?
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BE CAREFUL
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OTHER MEDICINES AND GENVOYA
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HOW DOES GENVOYA WORK?
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OPTIMAL USE
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ONE TABLET EVERY DAY
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KEEP TRACK
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MISSED A DOSE?
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POSSIBLE SIDE EFFECTS
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PREGNANCY AND BREAST-FEEDING
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CO-INFECTION 24
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HEALTHY LIFESTYLE
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SWITCHING FROM STRIBILD TO GENVOYA
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SWITCHING FROM TRUVADA TO GENVOYA
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SWITCHING FROM ATRIPLA TO GENVOYA
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SEVEN IMPORTANT TIPS
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FREQUENTLY ASKED QUESTIONS
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WHAT IS HIV?
WHAT IS GENVOYA?
The human immunodeficiency virus (HIV) infects specific
HIV-infection can be treated with Genvoya
cells of the immune system, known as CD4 cells. Prolonged
Genvoya causes the viral load to drop, through the
infection weakens the immune system. The virus continues
inhibition of viral replication. As a result, virus replication
to create multiple copies of itself, causing your CD4 cell
is reduced and many of the remaining virus particles are
count to reduce. As a result, your body is less capable of
eliminated from the body.
fighting infections and illnesses. Genvoya contains a combination of active substances, At the time these infections and illnesses occur, there is
in one tablet. Also, Genvoya can be taken with certain
the risk of Acquired Immune Deficiency Syndrome (AIDS).
medication for other diseases, however not with all
To prevent AIDS, it is important to treat HIV in time with
medications (see page 9: ‘Other medicines and Genvoya’).
the proper treatment.2 This allows the immune system to
This treatment is for use by adults and adolescents aged
continue to do its job. The primary goal of HIV-treatment is
12 years and older, with a body weight of at least 35 kg.
level (undetectable viral load). As a result, the number of
ACTIVE SUBSTANCES IN GENVOYA:
CD4 cells will remain sufficient, i.e. the immune system is
• elvitegravir
• cobicistat
more capable to fight off infections and diseases.
• emtricitabine
• tenofovir alafenamide
HIV can be transmitted from an infected person to an
Elvitegravir is an antiretroviral medicine known as an integrase
uninfected person through body fluids, such as genital
inhibitor, cobicistat is a booster (pharmacokinetic enhancer)
fluids (semen, pre-seminal fluid, rectal fluids and vaginal
of the effects of elvitegravir, without anti-HIV activity,
fluids) during unprotected sexual contact (vaginal, anal and
emtricitabine and tenofovir alafenamide are antiretroviral
oral), donor sperm, donor tissue, blood products, blood
medicines. Each tablet contains 150 mg elvitegravir,
from contaminated needles, or mother to child during
150 mg cobicistat, 200 mg emtricitabine and 10 mg
pregnancy, childbirth and breast-feeding.
tenofovir alafenamide.
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2,3
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INFORMATION FOR PATIENTS
to reduce the amount of viral particles to an undetectable
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BE CAREFUL What do you need to know before taking Genvoya? Restrictions apply to all medications, including Genvoya.
OTHER MEDICINES AND GENVOYA Are you taking any other medicines? Genvoya may interact with other medicines.
DO NOT TAKE GENVOYA IF: • you are allergic to elvitegravir, cobicistat,
DO NOT TAKE GENVOYA AND TELL YOUR DOCTOR
emtricitabine, tenofovir alafenamide or any of the
IMMEDIATELY IF YOU ARE TAKING:
other ingredients of this medicine (see package
• medicines used in treating hepatitis B infection:
leaflet for a full list).
tenofovir disoproxil, lamivudine, adefovir dipivoxil • alfuzosin, used to treat an enlarged prostate gland
BE CAREFUL IF: • you have liver problems or a history of liver disease, including hepatitis. • you are intolerant to lactose.
• amiodarone, quinidine, used to correct irregular heartbeats • carbamazepine, phenobarbital, phenytoin, used to prevent seizures
For additional information, please refer to the package leaflet. If any of these conditions apply to you, tell your doctor, even if he or she has not asked.
other infections • dihydroergotamine, ergometrine, ergotamine, used to treat migraine headache • cisapride, used to relieve certain stomach problems • St. John’s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it
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INFORMATION FOR PATIENTS
• rifampicin, used to prevent and treat tuberculosis and
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• lovastatin, simvastatin, used to lower blood cholesterol
• immunosuppressants, used to control your body’s
• pimozide, used to treat abnormal thoughts or feelings
immune response after a transplant, such as:
• sildenafil, when used to treat pulmonary arterial
ciclosporin, sirolimus and tacrolimus
hypertension • orally administered midazolam, triazolam, used to help you sleep and/or relieve anxiety
• corticosteroids including: betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone • medicines used to treat diabetes: metformin • contraceptive pill, used to prevent pregnancy
• antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole • antibiotics, used to treat bacterial infections including tuberculosis, containing: rifabutin, clarithromycin and telithromycin • antiviral medicines used to treat hepatitis C: telaprevir and boceprevir • antidepressants, used to treat depression: medicines containing trazodone or escitalopram • sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem and lorazepam
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• erectile dysfunction medicines, used to treat impotence, such as: sildenafil, tadalafil and vardenafil • heart medicines, such as: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil • medicines used to treat pulmonary arterial hypertension: bosentan and tadalafil • anticoagulants, used to thin the blood, such as: warfarin and dabigatran
INFORMATION FOR PATIENTS
TALK TO YOUR DOCTOR IF YOU ARE TAKING:
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• bronchodilators, used to treat asthma and other lung-related problems: salmeterol • cholesterol lowering medicines, such as: atorvastatin and pitavastatin • medicines used to treat gout: colchicine
HOW DOES GENVOYA WORK? How do you know if your treatment is working well? In order to determine whether Genvoya works for you, blood is taken for examination. Test results can show whether the amount of virus (viral load) has decreased and the amount of CD4 cells has increased.
If you are taking an antacid or a multivitamin supplement, take it at least 4 hours before or at least 4 hours
You can still pass on HIV when taking this medicine,
after Genvoya.
although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed
Tell your doctor or pharmacist if you are taking, have
This medicine is not a cure for HIV infection. While
recently taken or might take any other medicines. If you are
taking Genvoya you may still develop infections or
considering stopping your treatment with Genvoya, contact
other illnesses associated with HIV infection.
your doctor to discuss the possibilities. Do not stop your treatment without contacting your doctor. For full details about using Genvoya please refer to the package leaflet.
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INFORMATION FOR PATIENTS
to avoid infecting other people.
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OPTIMAL USE Intake of Genvoya
If the virus develops resistance, the active substances in
When you take Genvoya, the active substances enter your
Genvoya are no longer able to effectively inhibit the virus.
blood stream through the digestive tract. Genvoya then
If you consider stopping your treatment with Genvoya,
disappears from your blood and you need to take another
talk to your doctor or nurse. They can assist you in
dose. The recommended dose is one tablet every day.
finding the proper solution.
When you miss a dose, less Genvoya is present in your
Tell your doctor or pharmacist if you are taking, have
body to inhibit viral replication. This has two serious
recently taken or might take any other medicines. If you
disadvantages. First, because there is less Genvoya, the
are considering stopping your treatment with Genvoya,
virus is better able to multiply and attack the immune
contact your doctor to discuss the possibilities.
system. Second, the virus may change its shape while
INFORMATION FOR PATIENTS
multiplying, and the new virus may become resistant.
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ONE TABLET EVERY DAY
KEEP TRACK
What to be aware of when taking Genvoya?
Make sure you keep track
Once you have started Genvoya, two things are of
At times you may not remember if you have taken your daily
importance. First, the level of Genvoya in your body must
dose. If this problem occurs frequently, make sure you set
be maintained. Second, you should immediately talk to
up a monitoring system. For example, use a pill organiser,
your doctor if you notice any side effects.
labelled with the days of the week, in which you can store your daily dose. There are also daily pill boxes that you attach
The recommended dose is one tablet every day, with
as a keychain to allow you quick access to spare tablets.
a dose is minimized. However, the absorption of Genvoya
Have spare tablets handy
is disrupted if you vomit less than 1 hour after the intake,
Life is full of surprises, and it may happen that you are
or if you are suffering from severe diarrhoea. On page
somewhere else than expected at your scheduled time of
18 ‘Missed a dose?’ you can read what to do in these
intake. Therefore it is important to make sure you always
situations.
have some extra tablets with you.
Choose a convenient time of intake
If necessary, set an alarm clock
For instance, when you take Genvoya in the evening
You could set an alarm clock on your mobile phone to
during dinner, it becomes a habit and the risk of missing
remind you to take Genvoya. There are also pill organisers
a dose is minimized.4
with a built-in alert system. Genvoya during your holiday During holidays, daily routines are often broken, especially if you are travelling across time zones. If you are travelling
INFORMATION FOR PATIENTS
food, at about the same time. Thereby, the risk of missing
to a different time zone, please consult your doctor about the best dosing schedule. It is best to maintain the 24 hour interval between doses.
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MISSED A DOSE? Missed a dose?
When your supply of Genvoya starts to run low, go to
It is normal to occasionally forget something. It may
your doctor for a new prescription. This is very important
happen that, despite all good intentions and precautions
because the amount of virus may start to increase if the
you still forget to take your medication. Discuss in advance
medicine is stopped for even a short time. The disease
with your doctor or HIV-consulent what to do in
may then become harder to treat. Do not take a double
this situation.
dose to compensate for the missed tablet.
In general, the following applies:
If you vomit less than 1 hour after taking Genvoya, take another tablet with food. If you are suffering from severe
Did you miss a dose of Genvoya? ... If you notice within 18 hours
... If you notice after 18 hours or more
take the tablet as soon as possible (with food)
skip the missed dose
insufficiently absorbed by the body. Therefore, contact your doctor if you are suffering from severe diarrhoea for
Do not stop taking Genvoya without talking to your doctor. When your supply of Genvoya starts to run low, refill your prescription at your pharmacist.
INFORMATION FOR PATIENTS
more than two days.
WAIT AND TAKE THE NEXT DOSE AT YOUR USUAL TIME (WITH FOOD).
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diarrhoea, there is a risk that Genvoya is not absorbed or
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POSSIBLE SIDE EFFECTS Like all medicines, Genvoya can cause side effects,
Common side effects
although this differs between individuals. When treating
(may affect up to 1 in 10 people)
HIV infection, it is not always possible to tell whether
• abnormal dreams
some of the unwanted effects are caused by Genvoya,
• headache
other medicines that you are taking at the same time, or
• dizziness
by the HIV disease itself.
• diarrhoea • vomiting
Possible serious side effects
• stomach pain
• Any signs of inflammation or infection.
• wind (flatulence)
• Autoimmune disorders. Look out for any symptoms of
• rash
infection or other symptoms such as: muscle weakness,
• tiredness (fatigue)
up towards the trunk of the body. palpitations, tremor
Uncommon side effects
or hyperactivity.
(may affect up to 1 in 100 people) • low red blood cell count (anaemia)
If you notice the side effects described above, tell your
• depression
doctor immediately.
• problems with digestion resulting in discomfort after
Very common side effects
• swelling of the face, lips, tongue or throat (angioedema)
(may affect more than 1 in 10 people)
• itching (pruritus)
meals (dyspepsia)
• feeling sick (nausea) If any of the side effects get serious tell your doctor.
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INFORMATION FOR PATIENTS
weakness beginning in the hands and feet and moving
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Other effects that may be seen during HIV treatment
PREGNANCY AND BREAST-FEEDING
During HIV therapy there may be an increase in weight
You cannot use Genvoya during pregnancy, unless this is
and in levels of blood lipids and glucose. This is partly
specifically discussed with your doctor.
linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Contraception
Your doctor will test for these changes.
Women are advised to use effective contraception while taking Genvoya to avoid pregnancy.
Some patients may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of
Pregnancy
blood supply to the bone). Signs of osteonecrosis are:
If you are pregnant, think you may be pregnant or are
• joint stiffness;
planning to have a baby, ask your doctor for advice
• joint aches and pains (especially of the hip, knee,
before you start taking this medicine.
and shoulder); Breast-feeding Do not breast-feed during treatment with Genvoya. Reporting of side effects
Active substances in this medicines are excreted in
If you get any side effects, talk to your doctor or
breast milk.
pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects
It is also recommended that you do not breast-feed to
directly via the national reporting system:
avoid passing the virus to the baby through breast milk.
Nederlandse Bijwerkingen Centrum Lareb Website: www.lareb.nl
INFORMATION FOR PATIENTS
• difficulty with movement.
By reporting side effects you can help provide more information on the safety of this medicine.
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CO-INFECTION
HEALTHY LIFESTYLE
Hepatitis
Tips for a healthy lifestyle
Patients with liver disease, including chronic hepatitis B or
The HIV-virus suppresses your immune system. Although
C, who are treated with antiretrovirals, have a higher risk
Genvoya reduces this suppression, it is still important to not
of severe and potentially fatal liver complications. If you
impose an extra burden on your immune system, and adopt
are infected with the hepatitis B-virus, your doctor should
a healthy lifestyle. Live healthy, eat healthy, sleep well.
carefully consider the best treatment regimen for you. HEALTHY LIFESTYLE If you are infected with the hepatitis B-virus and stop taking Genvoya, you may put yourself at risk of severe acute liver
• perform physical activity (e.g. walking, playing sports, cycling) on regular basis
complications. It is therefore important to not stop taking
• do relaxation exercises (e.g. yoga)
Genvoya without talking to your doctor.
• eat fruits and vegetables • quit smoking
SLEEP WELL • maintain a regular sleep pattern • relax before going to bed (e.g. reading, a hot bath) • do not work out before going to bed • do not drink coffee or eat chocolate in the evening • do not eat a large meal before going to bed • ensure a dark, quiet bedroom (use earplugs if
INFORMATION FOR PATIENTS
• limit or avoid the use of alcohol and recreational drugs
necessary) • do not oversleep
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM STRIBILD TO GENVOYA.
SWITCHING FROM STRIBILD TO GENVOYA What is the difference between Stribild and Genvoya?
Active substances
Stribild contains four active substances, elvitegravir,
Elvitegravir is an antiretroviral medicine known as
cobicistat, emtricitabine and tenofovir disoproxil
integrase inhibitor.
(as fumarate). Cobicistat is a booster (pharmacokinetic enhancer) of the Genvoya also contains four substances, elvitegravir,
effects of elvitegravir.
fumarate. Of the four substances, three are the same
Emtricitabine is an antiretroviral medicine, known as
as in Stribild. In Genvoya, the active substance tenofovir
nucleoside reverse transcriptase inhibitor (NRTI).
disoproxil fumarate is replaced by tenofovir alafenamide (as fumarate). In the following chart you will find
Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral
an overview.
medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI). It is converted to tenofovir in the body.
STRIBILD®
GENVOYA®
• Elvitegravir 150 mg
• Elvitegravir 150 mg
• Cobicistat 150 mg
• Cobicistat 150 mg
• Emtricitabine 200 mg
• Emtricitabine 200 mg
• Tenofovir disoproxil (as fumarate) 245 mg
• Tenofovir alafenamide (as fumarate) 10 mg
Tenofovir is the active substance. Tenofovir alafenamide (as fumarate, TAF) is an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI). It is converted to tenofovir in the body. Tenofovir is the active substance. TAF is converted to tenofovir in a different way compared to
SWITCHING FROM STRIBILD TO GENVOYA
cobicistat, emtricitabine and tenofovir alafenamide
TDF. This means with a lower dose you get the same effect on the virus.
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM STRIBILD TO GENVOYA.
WHAT REMAINS THE SAME WHEN YOU SWITCH FROM STRIBILD TO GENVOYA The number of tablets you take each day
Booster
You take one tablet each day.
Both Stribild and Genvoya contain the active substance cobicistat. This is a booster (pharmacokinetic ‘booster’) from
Intake with food
the effects of elvitegravir. By using boosters, your doctor
You should take Genvoya with food.
and pharmacist will be on extra alert for possible changes (‘interactions’) between the booster and other medication.
Your medicines will be supplied by your regular pharmacy. Your pharmacy will be able to supply medication for at least three months. Missed a dose? If you do miss a dose and notice within 18 hours of the time you usually take Genvoya, you should take the tablet as soon as possible. However, if you notice 18 hours or more after the time you usually take Genvoya, then do not take the missed dose. Wait and take the next dose, with food, at your usual time.
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SWITCHING FROM STRIBILD TO GENVOYA
Pharmacy
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM STRIBILD TO GENVOYA.
THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM TRUVADA TO GENVOYA.
WHAT CAN CHANGE WHEN YOU SWITCH FROM STRIBILD TO GENVOYA
SWITCHING FROM TRUVADA AND BOOSTED PROTEASE INHIBITOR TO GENVOYA
Active substances
What is the difference between Truvada and Genvoya?
Both Stribild and Genvoya contain four active substances.
Truvada contains two substances, emtricitabine and
In Genvoya, the active substance tenofovir disoproxil
tenofovir disoproxil (as fumarate). In addition to Truvada,
(as fumarate) is replaced with tenofovir alafenamide
you take a protease inhibitor and a booster. This booster
(as fumarate). You doctor can tell you more about this.
can be a component of the third medication or prescribed as a separate tablet.
Kidney monitoring tests When you were taking Stribild, your doctor possibly
Genvoya contains four substances, elvitegravir, cobicistat,
ordered blood tests during treatment to monitor your
emtricitabine and tenofovir alafenamide fumarate. In the
kidneys. When you take Genvoya, it is not necessary to
following chart you will find an overview.
decide whether or not to continue kidney monitoring. Possible side effects
PROTEASE INHIBITOR*
GENVOYA®
• Protease inhibitor
• Elvitegravir 150 mg
+ BOOSTER
All medicines can cause side effects, and switching to
• Booster
a new HIV-treatment may also cause new side effects.
+ TRUVADA®
Some of the possible side effects of Genvoya are
• Emtricitabine 200 mg • Tenofovir disoproxil (as fumarate) 245 mg
described in this booklet. Discuss with your doctor or HIV-consulent what differences you can expect between your current treatment and Genvoya.
• Cobicistat 150 mg • Emtricitabine 200 mg • Tenofovir alafenamide (as fumarate) 10 mg
INFORMATION FOR PATIENTS
assess your kidneys on a regular basis. Your doctor will
* The booster can be part of the same tablet as the protease inhibitor, or prescribed as a separate tablet.
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Active substances
Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral
A protease inhibitor is a class within the HIV-inhibitors.
medicine known as a nucleotide reverse transcriptase
Commonly used protease inhibitors are atazanavir,
inhibitor (NtRTI). It is converted to tenofovir in the body.
darunavir and lopinavir.
Tenofovir is the active substance.
Often, a protease inhibitor works together with a
Tenofovir alafenamide (as fumarate, TAF) is an
pharmakinetic booster also known as ‘booster’. The most
antiretroviral medicine known as a nucleotide reverse
used boosters are cobicistat and ritonavir. The booster
transcriptase inhibitor (NtRTI). It is converted to tenofovir
can be part of the same tablet as the protease inhibitor,
in the body. Tenofovir is the active substance. TAF is
or prescribed as a separate tablet.
converted to tenofovir in a diff erent way compared to
Elvitegravir is an antiretroviral medicine known as integrase inhibitor. Cobicistat is a booster (pharmacokinetic enhancer) of the effects of elvitegravir. Emtricitabine is an antiretroviral medicine, known as nucleoside reverse transcriptase inhibitor (NRTI).
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effect on the virus.
SWITCHING FROM TRUVADA TO GENVOYA
TDF. This means with a lower dose you get the same
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM TRUVADA TO GENVOYA.
WHAT REMAINS THE SAME WHEN YOU SWITCH FROM TRUVADA TO GENVOYA
WHAT CAN CHANGE WHEN YOU SWITCH FROM TRUVADA TO GENVOYA
A fixed time of intake
One tablet a day
You have to take your HIV-medication at a fixed time
You take one tablet each day.
of the day. As you can see on page 31, Genvoya contains other active
You have to take Genvoya with food. It is not necessary
substances than Truvada. These active substances may
to take the tablet with a meal.
have different long-term effects. Your doctor or HIV-consulent can tell you more about the long-term
Pharmacy
effects of Genvoya.
Your medicines can be picked up at your regular pharmacy. Your pharmacy will be able to supply
Side effects
medication for at least three months.
All medicines can cause side effects, and switching to a new HIV-treatment may also cause new side effects.
Booster
The possible side effects of Genvoya are described in
Both your current treatment combination and Genvoya
this brochure. Discuss with your doctor or HIV-consulant
contain a pharmacokinetic booster. By using boosters,
what differences you can expect between your current
your doctor and pharmacist will be on extra alert for
treatment and Genvoya.
possible changes (‘interactions’) between the booster
SWITCHING FROM TRUVADA TO GENVOYA
Long-term effects Intake with food
and other medication.
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM TRUVADA TO GENVOYA.
THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM ATRIPLA TO GENVOYA.
Kidney monitoring
SWITCHING FROM ATRIPLA TO GENVOYA
Before your treatment with Truvada started, your doctor possibly assessed your kidney function. Your doctor also possibly ordered blood tests during treatment to monitor
What is the difference between Atripla and Genvoya?
your kidneys. If you switch from Truvada to Genvoya, it is
Atripla contains three active substances, efavirenz,
not necessary to assess your kidneys on a regular basis.
emtricitabine and tenofovir disoproxil (as fumarate).
It is up to your doctor, whether he continues these blood tests.
Genvoya contains four substances, elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (as fumarate).
Missed a dose?
In the following chart you will find an overview.
time you usually take Genvoya, you should take the tablet as soon as possible. Then take the next dose as usual.
ATRIPLA®
GENVOYA®
However, if you notice 18 hours or more after the time you
• Efavirenz 600 mg
• Elvitegravir 150 mg
usually take Genvoya, then do not take the missed dose.
• Cobicistat 150 mg
Wait and take the next dose at your usual time.
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• Emtricitabine 200 mg
• Emtricitabine 200 mg
•T enofovir disoproxil (as fumarate) 245 mg
• Tenofovir alafenamide (as fumarate) 10 mg
SWITCHING FROM ATRIPLA TO GENVOYA
If you do miss a dose and notice within 18 hours of the
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM ATRIPLA TO GENVOYA.
Active substances Efavirenz is an antiretroviral medicine known as nonnucleoside reverse transcriptase inhibitor (NNRTI). Elvitegravir is an antiretroviral medicine known as
WHAT REMAINS THE SAME WHEN YOU SWITCH FROM ATRIPLA TO GENVOYA
integrase inhibitor. The number of tablets you take each day Cobicistat is a booster (pharmacokinetic enhancer) of the
You take one tablet each day.
effects of elvitegravir. Pharmacy Emtricitabine is an antiretroviral medicine, known as
Your medicines can be picked up at your regular
nucleoside reverse transcriptase inhibitor (NRTI).
pharmacy. Your pharmacy will be able to supply
Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral medicine known as a nucleotide reverse
A fixed time of intake
transcriptase inhibitor (NtRTI). It is converted to tenofovir
You take your HIV-medication at a fixed time of the day.
in the body. Tenofovir is the active substance.
With Genovya this will remain the same.
Tenofovir alafenamide (as fumarate, TAF) is an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI). It is converted to tenofovir in the body. Tenofovir is the active substance. TAF is converted to tenofovir in a different way compared to TDF. This means with a lower dose you get the same
SWITCHING FROM ATRIPLA TO GENVOYA
medication for at least three months.
effect on the virus.
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WHAT CAN CHANGE WHEN YOU SWITCH FROM ATRIPLA TO GENVOYA Long-term effects
Intake with food
As you can see on page 37, Genvoya contains other
You should take Genvoya with food. It is not necessary
active substances than Atripla. These active substances
to take the tablet with a meal.
may have different long-term effects. Your doctor or HIV-consulent can tell you more about the long-term
Booster
effects of Genvoya.
Genvoya contains the active substance cobicistat. effects of elvitegravir. By using boosters, your doctor
All medicines can cause side effects, and switching to a
and pharmacist will be on extra alert for possible changes
new HIV-treatment may mean you experience side effects
(‘interactions’) between the booster and
that you didn’t experience when taking your previous
other medication.
medicine. Some of the possible side effects of Genvoya are described in this booklet. Discuss with your doctor
Missed a dose?
what differences you might expect between your current
If you do miss a dose and notice within 18 hours of the
treatment and Genvoya.
time you usually take Genvoya, you should take the tablet as soon as possible. Then take the next dose as usual.
Kidney monitoring tests
However, if you notice 18 hours or more after the time you
When you were taking Atripla, your doctor possibly
usually take Genvoya, then do not take the missed dose.
ordered blood tests during treatment to monitor your
Wait and take the next dose at your usual time.
kidneys. When you take Genvoya, it is not necessary to
SWITCHING FROM ATRIPLA TO GENVOYA
This is a booster (pharmacokinetic ‘booster’) from the Possible side effects
assess your kidneys on a regular basis. It is up to your doctor, whether he continues these blood tests.
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SEVEN IMPORTANT TIPS 1. Take one tablet at about the same time every day.
6. If you are taking an antacid or a multivitamin
This makes it easier to remember your daily intake
supplement, take it at least 4 hours before or at least
of Genvoya. For example, take Genvoya every day
4 hours after Genvoya.
with a particular meal. 7. Make sure you always have a supply of Genvoya at 2. Take one tablet every day with food (breakfast, lunch, dinner or snack).
home. Remember to request for a prescription refill in time. If you leave home or are travelling, always take Genvoya with you.
3. Do not chew, crush or split the tablet. 4. If you vomit less than 1 hour after taking Genvoya, take another tablet. When in doubt, always contact your doctor or HIV-consulent. 5. It is important not to miss a dose of Genvoya. If you do miss a dose: • If you notice within 18 hours of the time you usually take Genvoya, you must take the tablet with food as soon as possible. Then take the next dose as usual.
• If you notice 18 hours or more after the time you usually take Genvoya, then do not take the missed dose. Wait and take the next dose, with food, at your
IMPORTANT TIPS
usual time.
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FREQUENTLY ASKED QUESTIONS Genvoya reduces the amount of viral particles by
Genvoya is an anti-human immunodeficiency virus (HIV)
inhibiting the replication of the virus. The treatment is
medicine. This means that this medicine contributes to
successful if the amount of viral particles (viral load) in
the treatment of HIV-infection. It helps prevent the HIV
your blood is reduced to an undetectable level. Then, the
from replicating and creating copies of itself, and slows
number of CD4 cells will increase, i.e. the immune system
down the progression of the disease.
recovers from its weakened state.
What does my medicine look like?
What are the ingredients of Genvoya?
Genvoya film-coated tablets are green, capsule-shaped
Genvoya contains four active substances: elvitegravir,
tablets, debossed on one side with “GSI” and the number
cobicistat, emtricitabine and tenofovir alafenamide. These
“510” on the other side of the tablet. Genvoya comes in
are antiretroviral medicines. Each tablet contains 150 mg
bottles of 30 tablets, and a silica gel desiccant (that must
elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and
be kept in the bottle to help protect your tablets).
10 mg tenofovir alafenamide.
The silica gel desiccant is packaged in a separate sachet or canister and should not be swallowed.
Does this medicine cure HIV? No, this medicine is not a cure for HIV-infection. To
How does this medicine work?
control your HIVinfection and infections or other illnesses
HIV infects specific cells of the immune system and
associated with HIV-infection, you should always take this
therefore weakens the immune system. The HIV-virus
medication exactly as your doctor has prescribed it.
creates multiple copies of itself that continue to weaken the immune system. As a result, your body is less capable
FREQUENTLY ASKED QUESTIONS
Why have I been prescribed this medicine?
of fighting infections and illnesses.1
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Who can prescribe Genvoya?
How do I take my medicine?
Genvoya is a prescription medicine that can only be
Always take this medication exactly as your doctor has
prescribed by a healthcare professional.
prescribed it. Check with your doctor or pharmacist if
You should only take this medication if it has been
you are not sure. The recommended daily intake is one
prescribed by your doctor.
tablet every day with food. Do not chew, crush or split
the tablet.
When should I not take this medication? If you are allergic to emtricitabine, tenofovir alafenamide
How should I store this medicine?
or any of the other ingredients of this medicine (you can
Store Genvoya in its original packaging to protect from
find all ingredients in the package leaflet) or if you use
moisture. Keep the bottle tightly closed. Keep the
any of the other medicines mentioned on page 9 in the
tablets out of sight and reach of children. Do not use this
section “Other medicines and Genvoya”.
medication after the expiry date. Ask your pharmacist
HIV to other people?
What do I need to tell my doctor before I start taking
You can still transmit HIV when taking this medicines,
this medicine?
although the risk is lowered by effective antiretroviral
Tell your doctor or pharmacist if you are taking, have
therapy. Discuss with your doctor the precautions needed
recently taken or are going to take any other medicines.
to avoid infecting other people. This medicine is not a
Tell your doctor if you are allergic to any of the
cure for HIV-infection. While taking Genvoya you may
ingredients (see package leaflet for a full list) or if you
still develop infections or other illnesses associated with
are pregnant, are likely to become pregnant or if you
HIV-infection.
are breastfeeding. Also tell your doctor if you have liver
FREQUENTLY ASKED QUESTIONS
how to throw away medicines you no longer use. Does my medicine reduce the risk of me transmitting
problems, or a history of liver disease, including hepatitis.
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Can this medicine cause side effects?
If you notice 18 hours or more after the time you usually
As with all medicines, you may get side effects. On page
take Genvoya, then do not take the missed dose. Wait
20 you will find possible side effects. For a full list of side
and take the next dose at your usual time. If you vomit
effects, please refer to the package leaflet that is supplied
less than 1 hour after taking your medication, take
with your medication. If you notice any side effects, talk
another tablet. Do not stop taking Genvoya without first
to your doctor or pharmacist. This includes any possible
talking to your doctor.
side effects not listed in the package leaflet. breast-feeding?
taking Genvoya?
If you are pregnant, think you may be pregnant or are
Yes. You should look out for symptoms of inflammation,
planning to have a baby, ask your doctor for advice
infection or autoimmune disorders, such as muscle
before taking this medicine. Use effective contraception
weakness, palpitations, tremors or hyperactivity. If you
while taking Genvoya to avoid getting pregnant.
notice one of these symptoms, please tell your doctor immediately. For more information, please refer to the
Do not breast-feed during treatment with this medicine.
package leaflet.
This is because some of the active substances in this medicine are excreted in breast milk.
What do I do if I miss a dose of my medicine? It is important to not miss a dose of Genvoya. If you
It is also recommended that you do not breast-feed
notice within 18 hours of the time you usually take your
to avoid transmitting the virus to the baby through
medication, take the tablet as soon as you remember.
breast milk.
Take the tablet with food and then take the next dose
FREQUENTLY ASKED QUESTIONS
Should I take this medicine if I am pregnant or if I am Is it possible to experience serious side effects while
at the usual time.
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NOTES
NOTES
NOTES
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TAF/NL/16-01/NPM/1035(1)a Date of preparation: November 2017
REFERENCES 1. Package leaflet Genvoya www.cbg-meb.nl/geneesmiddeleninformatiebank 2. Rijksinstituut voor Volksgezondheid en Milieu. Ministerie van Volksgezondheid, Welzijn en Sport. LCI guideline HIV infection. Verkregen op 11 februari 2016, van https://lci.rivm.nl/richtlijnen/hivinfectie 3. Living with HIV and AIDS, www.nhs.uk/Conditions/HIV/Pages/living-with.aspx. 4. Compliance, www.rivm.nl/Documenten_en_publicaties/Professioneel_Praktisch/ Stappenplannen/Infectieziekten/VSI/VSI_Hiv