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Triumeq
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• Continue to practise safer sex and take • Gastrointestinal symptoms (including
other precautions to prevent passing HIV nausea, vomiting, diarrhea or belly pain)
on to other people and protect yourself
• General symptoms (including fatigue, lack of
from different strains of HIV as well as
energy, achiness)
other germs.
• Respiratory symptoms (sore throat, shortness
Warnings of breath, cough, unusual findings on X-rays
of the chest)
1. Hypersensitivity testing
If you develop symptoms from two or more
Before you first begin taking Triumeq, check of these groups while you are taking abacavir
with your doctor to find out if you have been or any drug containing abacavir, you should
screened for possible hypersensitivity to stop taking this medicine and contact your
abacavir, one of the drugs in Triumeq. This doctor right away. If your doctor confirms that
screening is written as HLA-B*5701 and is done a hypersensitivity reaction to abacavir has
with a simple blood test. If you test positive indeed occurred, then abacavir should never
for abacavir hypersensitivity then you cannot be restarted, as a fatal reaction could occur
use Triumeq, or any other medicine that within hours. You should also never take any
contains abacavir such as these: other drug that contains abacavir.
• Kivexa
2. Lactic acidosis and hepatic steatosis
• Ziagen
Two related conditions, lactic acidosis (a
• Trizivir buildup of lactic acid in the blood) and
hepatic steatosis (excess fat in the liver),
If you test negative, then your risk of
have occurred in some people who have used
having a hypersensitivity reaction is greatly
nucleoside analogues. These conditions can be
reduced. Speak to your doctor about your
serious or fatal. They have mostly been seen in
abacavir hypersensitivity results and whether
women and people who are overweight or who
it is safe for you to use Triumeq. For more
have been on nucleosides a long time, and can
information, see CATIE’s fact sheet Abacavir
cause the following symptoms:
hypersensitivity screening.
• nausea
About hypersensitivity
• vomiting
In up to 8% of people with HIV who use
• abdominal pain
abacavir, an exaggerated reaction against
abacavir by the immune system—abacavir • diarrhea
hypersensitivity—can occur. This reaction is
• unexpected tiredness
very serious and can be fatal.
• unexpected muscle pain
Although the hypersensitivity reaction can
occur at any time while a person is taking • unexpectedly feeling cold, especially in the
abacavir, on average it occurs within the arms and legs
first six weeks of use. The manufacturer, ViiV
• feeling dizzy or light-headed
Healthcare, states that you should stop using
abacavir if you have signs or symptoms from If any of these symptoms occur without
two or more of the following groups: apparent reason, call your nurse or doctor
right away.
• Fever
• Rash
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Lactic acidosis is rare. If you do develop any of 4. Hepatitis B
these symptoms, it does not necessarily mean
If someone with hepatitis B infection is taking
you have lactic acidosis, but you should still let
3TC—a component of Triumeq—the hepatitis
your doctor know right away.
can grow worse or “flare up” if the medication
is stopped. People who stop taking Triumeq
3. Cardiovascular risk
should be carefully monitored. If you are
There are conflicting data from some studies co-infected with HBV, talk to your doctor
about a link between heart attacks and the about how best to treat this co-infection.
initial use of abacavir-containing products
(Ziagen and in Triumeq, Kivexa and Trizivir). 5. Pregnancy
However, a review by the U.S. Food and Drug
Triumeq has not been studied in pregnant
Administration (FDA) of randomized clinical
women. Therefore the manufacturer states
trials has not found any link between abacavir
that “Triumeq should not be used in pregnant
use and an increased risk of heart attack.
women unless the potential benefits outweigh
Another large observational study, the French
the potential risks to the fetus.”
Hospital Database also assessed the risk of
heart attack among its participants who used If you are pregnant or want to have a baby,
abacavir. French researchers found that speak to your doctor about which medicines to
after adjusting for use of cocaine (a powerful take to keep you and your baby healthy.
stimulant that by itself can cause heart
attacks), exposure to abacavir was not linked Side effects
to an increased risk for heart attacks.
1. General
Therefore, all of the available data make it
difficult to draw firm conclusions about the Triumeq is generally well-tolerated. However,
possible role of abacavir and heart attacks. like many medicines, Triumeq can be
associated with these symptoms:
Therefore, as a precaution, before starting
Triumeq, let your doctor know if you have any • nausea
of these risk factors for cardiovascular disease:
• vomiting
• your close family members (mother, father,
• diarrhea
brother, sister) have a history problems such
as heart attack or stroke • headache
• have risk factors for cardiovascular disease • abdominal discomfort/pain
such as high blood pressure, abnormal
If these persist or are bothersome tell your
cholesterol or triglyceride levels in your
doctor right away.
blood, or have diabetes or pre-diabetes
• you use tobacco 2. Older people
• you use cocaine or club drugs or inject Triumeq has not been studied in large numbers
street drugs of people aged 65 or older. Older people
may have major organ systems (heart, liver,
Your doctor can help you find ways to reduce
kidneys and so on) that do not work as well as
your risk factors for cardiovascular disease.
in healthy younger people. Older people may
Your doctor can also help you decide if
also be taking multiple medicines that have
Triumeq is right for you.
the potential to interact with Triumeq. The
manufacturer therefore advises doctors that
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in people aged 65 or older Triumeq should be • fat pads at the back of the neck
used with caution. (“buffalo hump”) or at the base of the neck
(“horse collar”)
3. Liver
• small lumps of fat in the abdomen
The manufacturer does not recommend that
• increased breast size (in women)
Triumeq be used in people whose livers have a
“moderate to severe” degree of dysfunction. Together with these physical changes, blood
tests may detect the following:
4. The kidneys
• increased levels of fatty substances
The kidneys filter the blood and then put waste called triglycerides
materials into urine and reabsorb nutrients and
• increased levels of LDL-cholesterol (low-
other useful materials back into the blood.
density lipoprotein), or “bad” cholesterol
Triumeq contains dolutegravir. This drug can
• decreased levels of HDL-cholesterol (high-
interfere with the ability of the kidneys to
density lipoprotein), or “good” cholesterol
release the waste product creatinine into
urine. Therefore, a small but persistent • increased levels of sugar (glucose)
increase of creatinine levels in the blood is
• increased levels of the hormone insulin
generally seen in dolutegravir users. This
small increase is not considered harmful. • decreased sensitivity to insulin
Furthermore, this effect on creatinine does (insulin resistance)
not appear to affect the ability of the kidneys
The precise causes of the HIV lipodystrophy
to filter other substances. Such an effect on
syndrome are not clear and are difficult to
creatinine is also seen with the anti-ulcer
understand because some people with HIV
drug cimetidine (Tagamet) and with the
may experience one or more aspects of the
boosting agent cobicistat, found in Stribild
syndrome. For instance, some people may
and Prezcobix.
experience fat wasting, others fat gain, and
However, the manufacturer recommends that others may experience both fat wasting and
Triumeq not be used by people whose kidneys gain. What is becoming increasingly clear is
are not functioning normally. That is, people that unfavourable changes in levels of glucose,
whose eGFR (estimate glomerular filtration cholesterol and triglycerides over a period
rate) is less than 50 mL/min should not of several years increase the risk of diabetes
use Triumeq. and cardiovascular disease. So far, however,
the many benefits of ART far outweigh the
5. Lipodystrophy increased risk of cardiovascular disease and
other side effects.
The HIV lipodystrophy syndrome is the name
given to a range of symptoms that can Maintaining a normal weight, eating a healthy
develop over time when people use ART. diet, exercising regularly and quitting smoking
These include: are all important to help you to reduce your
risk of diabetes, heart disease and other
• loss of fat just under the skin (subcutaneous
complications. Regular visits to your doctor
fat) in the face, arms, and legs
for checkups and blood tests are a vital part of
• bulging veins in the arms and/or legs due to staying healthy. If necessary, your doctor can
the loss of fat under the skin prescribe lipid-lowering therapy.
• increased waist and belly size
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Researchers are studying lipodystrophy drug interactions with the dolutegravir
syndrome to try to discover ways to help (in Triumeq):
people with HIV avoid or reduce this problem.
Other HIV drugs
There is no evidence that Triumeq
Etravirine (Intelence) – this drug can reduce
(or the drugs in Triumeq) cause the
the concentration of dolutegravir in the blood.
lipodystrophy syndrome.
Therefore, the manufacturer recommends that
To find out more about options for managing dolutegravir should not be used with etravirine
aspects of lipodystrophy syndrome, see CATIE’s unless it is also taken with one of the following
A Practical Guide to HIV Drug Side Effects. combinations of drugs:
• atazanavir (Reyataz) + ritonavir (Norvir)
Uncommon side effects
• darunavir (Prezista) + ritonavir
Triumeq is a relatively new formulation and it
contains a relatively new drug (dolutegravir) • lopinavir + ritonavir (in Kaletra)
and as it becomes more widely used in the
Nevirapine (Viramune) – dolutegravir should
community, more side effects may appear.
not be used with nevirapine, as there is
Side effects that were rare in clinical trials not enough information to make dosing
included the following: recommendations.
• feeling sleepy in the day time Acid-reducing agents, laxatives, metal
supplements and buffered medicines
• muscle weakness
Dolutegravir should be taken 2 hours before or
• muscle pain
6 hours after taking these medicines.
Should any of these occur, let your doctor
Examples of acid-reducing agents include:
know right away.
• Alka-Seltzer
Drug interactions • Gaviscon (tablets and syrup)
In general, integrase inhibitors such as
• Maalox (liquid and tablets)
dolutegravir (one of the drugs in Triumeq)
tend not to interfere with many other drugs • Milk of Magnesia
(raising or lowering their levels in the blood).
• Pepto-Bismol and Pepto Bismol Childen’s
Dolutegravir causes few interactions with other
drugs. However, there are other medicines • Rolaids
that interfere with dolutegravir levels in the
• Tums
blood, usually decreasing them. Bear in mind
that as dolutegravir and Triumeq become more Metal supplements include those containing
widely used in the community, there may be iron, calcium and magnesium.
reports of new drug interactions.
Abnormal heart rhythm drugs
The manufacturer has not specifically
The drug dofetilide (Tikosyn) is prescribed to
conducted drug interaction studies with
treat abnormal heart rhythms. Dolutegravir
Triumeq. It has instead done drug interaction
can raise levels of dofetilide. Although
studies with a combination of the drugs used in
dofetilide is not approved in Canada, many
Triumeq (dolutegravir + abacavir + 3TC).
Canadians travel to the U.S. where it is
Here are recommendations from the approved and may be prescribed this medicine.
manufacturer about potentially significant The manufacturer warns that dofetilide
should never be used by patients who are
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taking dolutegravir, as high concentrations of Alcohol – although drinking alcohol can
dofetilide can occur causing serious injury. increase the concentration of abacavir
in the blood, this is not considered
Anti-seizure drugs
clinically meaningful.
Oxcarbazepine, carbamazepine (Tegretol),
These additional drugs should not be taken by
phenobarbital, phenytoin (Dilantin) –
someone using Triumeq – abacavir (Ziagen),
dolutegravir should not be used with these
Combivir, and Trizivir.
drugs as there is not enough information to
make dosing recommendations. Here are recommendations from the
manufacturer about potentially significant drug
Antibiotics
interactions with 3TC (in Triumeq):
Rifampin – this drug reduces the concentration
FTC (emtricitabine, Emtriva and in Hepsera,
of dolutegravir in the blood. The manufacturer
Truvada, Complera, Stribild and Atripla)
recommends that dolutegravir at a dose
– these drugs should not be taken by
of 50 mg twice daily should be used if
Triumeq users.
rifampin must also be taken. However, the
manufacturer also notes that in the case of
patients who have used integrase inhibitors
Resistance and cross-resistance
in the past and who have HIV that may be Over time, as new copies of HIV are made
or is suspected to be resistant to integrase in the body, the virus changes its structure.
inhibitors, doctors and nurses should These changes, called mutations, can cause
seek alternative antibiotics to rifampin HIV to resist the effects of anti-HIV drugs,
where possible. which means those drugs will no longer work
for you. Triumeq is a complete treatment in
Diabetes drugs
one pill.
Metformin – as dolutegravir can raise levels
To reduce the risk of developing drug
of metformin in the blood, the manufacturer
resistance, all anti-HIV drugs should be taken
recommends close monitoring of patients when
every day exactly as prescribed and directed.
they are starting or stopping therapy with
If doses are delayed, missed or not taken
dolutegravir. The manufacturer also suggests
as prescribed, the level of medicines in the
that it may be necessary to reduce the dose of
blood may fall too low. If this happens, the
metformin in some dolutegravir users.
HIV in your body can become resistant to
Herbs the medication. If you find you are having
problems taking your medications as directed,
St. John’s wort (or compounds found in St.
speak to your doctor, nurse or pharmacist
John’s wort such as hypericin, hyperforin) can
about this. They can find ways to help you.
significantly reduce dolutegravir levels and
this herb should not be used. Although St. When HIV becomes resistant to one drug in
John’s wort is the only herb listed here, note a class, it sometimes becomes resistant to
that other herbs are likely to interact with other drugs in that class. This is called cross-
dolutegravir. resistance. Feel free to talk with your doctor
about your current and future treatment
Here are recommendations from the
options. To help you decide what these
manufacturer about potentially significant drug
future options might be, at some point your
interactions with abacavir (in Triumeq):
doctor can have a small sample of your blood
Methadone – for most people no adjustment to analyzed to test for resistance. Should the HIV
their dose of methadone is needed. in your body become resistant to dolutegravir,
TRIUMEQ page 6 of 8
your doctor can recommend a new treatment Availability
combination for you.
Triumeq is licensed in Canada for the
For patients whose integrase inhibitor regimens treatment of HIV infection in adults. Your
are failing, doctors can request laboratory doctor can tell you more about the availability
testing of their blood to assess the degree of and coverage of Triumeq in your region.
resistance to integrase inhibitors. This will help CATIE’s online module Federal, Provincial and
doctors determine whether or not an integrase Territorial Drug Access Programs also contains
inhibitor can be used in future regimens. information about Canadian drug coverage.
In 2013, a study in the U.S. with about 3,000
HIV-positive participants who were undergoing
testing of their blood for the presence of HIV REFERENCE:
resistance was completed. Researchers found ViiV Healthcare ULC. Triumeq: dolutegravir, abacavir and
that resistance to integrase inhibitors was lamivudine tablets. Product monograph. October 2014.
present in 16% of participants. Their results
Author: Hosein SR
suggested that, in most cases, dolutegravir Published: 2014
would have “full or partial activity” against
most strains of HIV with integrase resistance.
However, 2% of all participants (or 12% of
participants with HIV resistant to the integrase
inhibitors raltegravir or elvitegravir) had “high-
level resistance to dolutegravir.”
Dosage
Triumeq is available as a purple film-coated
tablet. It contains the following drugs:
• dolutegravir – 50 mg
• abacavir — 600 mg
• 3TC – 300 mg
Triumeq is approved for use by adults 18 years
of age or older. It is a complete regimen in one
pill. It is meant to be taken once daily, day or
night, without food or water restrictions.
If you miss a dose, the manufacturer
recommends that you take it “as soon as you
remember, but if your next dose is due within
four hours, skip the dose you missed and take
your next one at the usual time. Then continue
your treatment as before.”
If you continue to miss doses, speak to your
doctor, nurse or pharmacist about ways of
helping you stick to a regular schedule of
pill-taking.
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Contact us
by telephone by e-mail
1.800.263.1638 info@catie.ca
416.203.7122
by mail
by fax 505-555 Richmond Street West
416.203.8284 Box 1104
Toronto ON M5V 3B1
Disclaimer
Decisions about particular medical treatments should always
be made in consultation with a qualified medical practitioner
knowledgeable about HIV- and hepatitis C-related illness and the
treatments in question.
Permission to reproduce
This document is copyrighted. It may be reprinted and distributed in
its entirety for non-commercial purposes without prior permission,
but permission must be obtained to edit its content. The following
credit must appear on any reprint: This information was provided
by the Canadian AIDS Treatment Information Exchange (CATIE). For
more information, contact CATIE at 1.800.263.1638.
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