ANTIVIRALS › NUCLEOSIDE REVERSE
▶ Common or very common Abdominal pain . anaemia (may
▶ Uncommon Hepatic steatosis . lactic acidosis . pancreatitis . thrombocytopenia
▶ Frequency not known Immune reconstitution
inflammatory syndrome . osteonecrosis . weight increased
SIDE-EFFECTS, FURTHER INFORMATION Osteonecrosis has
been reported in patients with advanced HIV disease or
following long-term exposure to combination
Monitoring Mitochondrial dysfunction has been reported
in infants exposed to nucleoside reverse transcriptase
inhibitors in utero; the main effects include
haematological, metabolic, and neurological disorders; all
infants whose mothers received nucleoside reverse
transcriptase inhibitors during pregnancy should be
monitored for relevant signs or symptoms.
l HEPATIC IMPAIRMENT In general, manufacturers advise
caution in patients with chronic hepatitis B or C (increased
risk of hepatic side-effects).
HIV infection in combination with other antiretroviral
▶ Adult: 600 mg daily in 1–2 divided doses
10-year cardiovascular risk greater than 20%)
l INTERACTIONS → Appendix 1: abacavir
▶ Common or very common Fever. lethargy
▶ Rare or very rare Severe cutaneous adverse reactions
▶ Frequency not known Hypersensitivity
SIDE-EFFECTS, FURTHER INFORMATION Life-threatening
hypersensitivity reactions have been reportedcharacterised by fever or rash and possibly nausea,
vomiting, diarrhoea, abdominal pain, dyspnoea, cough,
lethargy, malaise, headache, and myalgia; less frequently
mouth ulceration, oedema, hypotension, sore throat,
acute respiratory distress syndrome, anaphylaxis,
paraesthesia, arthralgia, conjunctivitis, lymphadenopathy,
lymphocytopenia and renal failure; rarely myolysis.
Laboratory abnormalities may include raised liver function
tests and creatine kinase; symptoms usually appear in the
first 6 weeks, but may occur at any time. Discontinue
immediately if any symptom of hypersensitivity develops
and do not rechallenge (risk of more severe
l ALLERGY AND CROSS-SENSITIVITY Caution—increased risk
of hypersensitivity reaction in presence of HLA-B*5701
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild impairment; consider avoiding in moderate to severe
impairment (no information available).
l RENAL IMPAIRMENT Manufacturer advises avoid in endstage renal disease.
l PRE-TREATMENT SCREENING Test for HLA-B*5701 allele
before treatment or if restarting treatment and HLAB*5701 status not known.
l MONITORING REQUIREMENTS Monitor for symptoms of
hypersensitivity reaction every 2 weeks for 2 months.
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include banana, or
l PATIENT AND CARER ADVICE Patients and their carers
should be told the importance of regular dosing
(intermittent therapy may increase the risk of
sensitisation), how to recognise signs of hypersensitivity,
and advised to seek immediate medical attention if
symptoms develop or before re-starting treatment.
Patients should be provided with an alert card and
advised to keep it with them at all times.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Propylene glycol
▶ Ziagen (ViiV Healthcare UK Ltd)
Abacavir (as Abacavir sulfate) 20 mg per 1 ml Ziagen 20mg/ml
oral solution sugar-free | 240 ml P £55.72
Abacavir (as Abacavir sulfate) 300 mg Abacavir 300mg tablets | 60 tablet P £177.61
▶ Ziagen (ViiV Healthcare UK Ltd)
Abacavir (as Abacavir sulfate) 300 mg Ziagen 300mg tablets | 60 tablet P £208.95
Abacavir with dolutegravir and
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, abacavir above, lamivudine p. 653,
▶ Adult (body-weight 40 kg and above): 1 tablet once daily
l INTERACTIONS → Appendix 1: abacavir. dolutegravir. lamivudine
l RENAL IMPAIRMENT Avoid Triumeq ® if eGFR less than
50 mL/minute/1.73 m2 (consult product literature).
Missed doses If a dose is more than 20 hours late, the
missed dose should not be taken and the next dose should
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Triumeq (ViiV Healthcare UK Ltd) A
Dolutegravir (as Dolutegravir sodium) 50 mg, Lamivudine
300 mg, Abacavir (as Abacavir sulfate) 600 mg Triumeq
50mg/600mg/300mg tablets | 30 tablet P £798.16
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, abacavir p. 647, lamivudine p. 653.
HIV infection in combination with other antiretrovirals
▶ Adult (body-weight 40 kg and above): 1 tablet once daily
l INTERACTIONS → Appendix 1: abacavir. lamivudine
l RENAL IMPAIRMENT Avoid Kivexa ® if eGFR less than
50 mL/minute/1.73 m2 (consult product literature).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Abacavir with lamivudine (Non-proprietary)
Lamivudine 300 mg, Abacavir 600 mg Abacavir 600mg /
Lamivudine 300mg tablets | 30 tablet P £190.00–£299.41 |
30 tablet P £224.56 (Hospital only)
▶ Kivexa (ViiV Healthcare UK Ltd)
Lamivudine 300 mg, Abacavir 600 mg Kivexa 600mg/300mg
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, abacavir p. 647, lamivudine p. 653,
HIV infection (use only if patient is stabilised for
6–8 weeks on the individual components in the same
l INTERACTIONS → Appendix 1: abacavir. lamivudine . zidovudine
l RENAL IMPAIRMENT Avoid Trizivir ® if eGFR less than
50 mL/minute/1.73 m2 (consult product literature).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Trizivir (ViiV Healthcare UK Ltd)
Lamivudine 150 mg, Abacavir (as Abacavir sulfate) 300 mg,
Zidovudine 300 mg Trizivir tablets | 60 tablet P £509.06
Bictegravir with emtricitabine and
tenofovir alafenamide 28-Sep-2018
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, emtricitabine p. 651, tenofovir alafenamide
HIV-1 infection (initiated by a specialist)
l INTERACTIONS → Appendix 1: bictegravir.tenofovir
l PREGNANCY Manufacturer advises use only if potential
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
severe impairment—no information available.
l RENAL IMPAIRMENT Manufacturer advises avoid if
creatinine clearance is less than 30 mL/minute—limited
Missed doses Manufacturer advises if a dose is more than
18 hours late, the missed dose should not be taken and the
next dose should be taken at the normal time.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (September
2018) that bictegravir with emtricitabine and tenofovir
alafenamide (Biktarvy ®) is accepted for use within NHS
Scotland for the treatment of adults infected with human
immunodeficiency virus type 1 without present or past
evidence of viral resistance to the integrase inhibitor class,
emtricitabine or tenofovir. This advice is contingent upon
the continuing availability of the patient access scheme in
NHS Scotland or a list price that is equivalent or lower.
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised
(December 2018) that bictegravir with emtricitabine and
tenofovir alafenamide (Biktarvy ®) is recommended as an
option for restricted use within NHS Wales for the
treatment of adults infected with human
immunodeficiency virus-1 (HIV-1) without present or past
evidence of viral resistance to the integrase inhibitor class,
emtricitabine or tenofovir, and who are either unsuitable
for or unable to tolerate abacavir with dolutegravir and
Bictegravir with emtricitabine and tenofovir
alafenamide (Biktarvy ®) is not recommended for use
within NHS Wales outside of this subpopulation. This
recommendation applies only in circumstances where the
approved Wales Patient Access Scheme (WPAS) is utilised
or where the list/contract price is equivalent or lower than
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 25
▶ Biktarvy (Gilead Sciences International Ltd) A
Tenofovir alafenamide (as Tenofovir alafenamide fumarate)
25 mg, Bictegravir 50 mg, Emtricitabine 200 mg Biktarvy
50mg/200mg/25mg tablets | 30 tablet P £879.51
HIV infection in combination with other antiretroviral
▶ Adult (body-weight up to 60 kg): 250 mg daily in
▶ Adult (body-weight 60 kg and above): 400 mg daily in
l CAUTIONS History of pancreatitis (preferably avoid,
otherwise extreme caution). hyperuricaemia . lactic
acidosis . peripheral neuropathy
▶ Lactic acidosis Lactic acidosis associated with hepatomegaly
and hepatic steatosis has been reported with didanosine.
Use with caution in patients with hepatomegaly, hepatitis,
or other risk factors for liver disease and hepatic steatosis
(including obesity and alcohol abuse). Discontinue
treatment if symptoms of hyperlactataemia, lactic
acidosis, progressive hepatomegaly or rapid deterioration
of liver function become apparent.
l INTERACTIONS → Appendix 1: didanosine
peripheral neuropathy develops)
▶ Uncommon Acute kidney injury . alopecia . diabetes
▶ Rare or very rare Parotid gland enlargement
▶ Frequency not known Lipoatrophy
SIDE-EFFECTS, FURTHER INFORMATION Pancreatitis
Suspend treatment if serum lipase raised or if symptoms of
pancreatitis develop; discontinue if pancreatitis
confirmed. Whenever possible avoid concomitant
treatment with other drugs known to cause pancreatic
toxicity; monitor closely if concomitant therapy
unavoidable. Since significant elevations of triglycerides
cause pancreatitis monitor closely if elevated.
Lipodystrophy syndrome Metabolic effects may occur
with didanosine: these include fat redistribution, insulin
resistance, and dyslipidaemia—collectively termed
lipodystrophy syndrome. Manufacturer advises monitoring
of plasma lipids and blood-glucose.
l PREGNANCY Manufacturer advises use only if potential
Monitoring In hepatic impairment, monitor for toxicity.
Dose adjustments Reduce dose if eGFR less than
l MONITORING REQUIREMENTS Ophthalmological
examination (including visual acuity, colour vision, and
dilated fundus examination) recommended annually or if
l DIRECTIONS FOR ADMINISTRATION Capsules should be
swallowed whole and taken at least 2 hours before or
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer didanosine capsules.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 25
▶ Videx EC (Bristol-Myers Squibb Pharmaceuticals Ltd)
Didanosine 125 mg Videx EC 125mg capsules | 30 capsule P £48.18 (Hospital only)
Didanosine 250 mg Videx EC 250mg capsules | 30 capsule P £96.37 (Hospital only)
Didanosine 400 mg Videx EC 400mg capsules | 30 capsule P £154.19 (Hospital only)
Efavirenz with emtricitabine and
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, tenofovir disoproxil p. 654, efavirenz p. 644,
HIV infection stabilised on antiretroviral therapy for more
l INTERACTIONS → Appendix 1: efavirenz .tenofovir
l HEPATIC IMPAIRMENT Manufacturer of Atripla ® advises
caution in mild impairment; avoid Atripla ® in moderate to
l RENAL IMPAIRMENT Avoid Atripla ® if eGFR less than
Missed doses If a dose is more than 12 hours late, the
missed dose should not be taken and the next dose should
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 23, 25
▶ Efavirenz with emtricitabine and tenofovir disoproxil (Nonproprietary)
Emtricitabine 200 mg, Tenofovir disoproxil (as Tenofovir
disoproxil fumarate) 245 mg, Efavirenz 600 mg Efavirenz 600mg
/ Emtricitabine 200mg / Tenofovir disoproxil 245mg tablets | 30 tablet P £479.58–£532.87
▶ Atripla (Gilead Sciences International Ltd)
Emtricitabine 200 mg, Tenofovir disoproxil (as Tenofovir
disoproxil fumarate) 245 mg, Efavirenz 600 mg Atripla
600mg/200mg/245mg tablets | 30 tablet P £532.87
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, emtricitabine p. 651, elvitegravir p. 643,
cobicistat p. 661, tenofovir alafenamide p. 622.
HIV-1 infection (specialist use only)
MHRA/CHM ADVICE: ELVITEGRAVIR BOOSTED WITH COBICISTAT:
AVOID USE IN PREGNANCY DUE TO RISK OF TREATMENT FAILURE
AND MATERNAL-TO-CHILD TRANSMISSION OF HIV-1 (APRIL 2019)
Pharmacokinetic data show mean exposure of
elvitegravir boosted with cobicistat (available in
combination in Genvoya ® and Stribild ®) to be lower
during the second and third trimesters of pregnancy
than postpartum. Low elvitegravir exposure may be
associated with an increased risk of treatment failure
and an increased risk of HIV-1 transmission to the
unborn child. For further information, see Pregnancy.
l INTERACTIONS → Appendix 1: cobicistat. elvitegravir. tenofovir alafenamide
▶ Uncommon Anaemia . angioedema . depression
▶ Frequency not known Nephrotoxicity . osteonecrosis . weight increased
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception in women of childbearing
potential; if using a hormonal contraceptive, it must
contain drospirenone or norgestimate as the progestogen
and at least 30 micrograms ethinylestradiol.
l PREGNANCY Manufacturer advises not to be initiated
during pregnancy due to low elvitegravir exposure; women
who become pregnant during therapy should be switched
l HEPATIC IMPAIRMENT Manufacturer advises caution
(increased risk of hepatic side-effects); avoid in severe
impairment (no information available).
l RENAL IMPAIRMENT Manufacturer advises avoid if
creatinine clearance less than 30 mL/minute—limited
l PRESCRIBING AND DISPENSING INFORMATION Dispense in
original container—contains desiccant.
Missed doses Manufacturer advises if a dose is more than
18 hours late, the missed dose should not be taken and the
next dose should be taken at the normal time.
Driving and skilled tasks Manufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (May 2016)
that elvitegravir with cobicistat, emtricitabine and
tenofovir alafenamide (Genvoya ®) is accepted for use
within NHS Scotland for the treatment of adults and
adolescents (aged 12 years and older with body weight at
resistance to the integrase inhibitor class, emtricitabine or
tenofovir. This advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland
or a list price that is equivalent or lower.
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised (July
2016) that elvitegravir with cobicistat, emtricitabine and
tenofovir alafenamide (Genvoya ®) is recommended as an
option for use within NHS Wales for the treatment of
adults and adolescents (aged 12 years and older with body
weight at least 35 kg) infected with human
immunodeficiency virus-1 (HIV-1), without known
mutations associated with resistance to the integrase
inhibitor class, emtricitabine or tenofovir. The
recommendation applies only if the approved Wales
Patient Access Scheme (WPAS) is used or where the list
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Genvoya (Gilead Sciences International Ltd) A
Tenofovir alafenamide 10 mg, Cobicistat 150 mg, Elvitegravir
150 mg, Emtricitabine 200 mg Genvoya
150mg/150mg/200mg/10mg tablets | 30 tablet P £879.51
emtricitabine and tenofovir disoproxil
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, tenofovir disoproxil p. 654, emtricitabine
p. 651, cobicistat p. 661, elvitegravir p. 643.
MHRA/CHM ADVICE: ELVITEGRAVIR BOOSTED WITH COBICISTAT:
AVOID USE IN PREGNANCY DUE TO RISK OF TREATMENT FAILURE
AND MATERNAL-TO-CHILD TRANSMISSION OF HIV-1 (APRIL 2019)
Pharmacokinetic data show mean exposure of
elvitegravir boosted with cobicistat (available in
combination in Genvoya ® and Stribild ®) to be lower
during the second and third trimesters of pregnancy
than postpartum. Low elvitegravir exposure may be
associated with an increased risk of treatment failure
and an increased risk of HIV-1 transmission to the
unborn child. For further information, see Pregnancy.
l INTERACTIONS → Appendix 1: cobicistat. elvitegravir. tenofovir disoproxil
pustular. skin reactions . sleep disorders . vomiting
▶ Uncommon Anaemia . angioedema . depression (in
patients with history of depression or psychiatric illness)
▶ Frequency not known Autoimmune disorder.Grave’s
disease . inflammation . osteonecrosis . weight increased
l CONCEPTION AND CONTRACEPTION Women of childbearing potential should use effective contraception
during treatment (if using a hormonal contraceptive, it
must contain norgestimate as the progestogen and at least
30 micrograms ethinylestradiol).
l PREGNANCY Manufacturer advises not to be initiated
during pregnancy due to low elvitegravir exposure; women
who become pregnant during therapy should be switched
l HEPATIC IMPAIRMENT Manufacturer advises caution
(increased risk of hepatic side-effects); avoid in severe
impairment (no information available).
l RENAL IMPAIRMENT If eGFR less than
, only initiate Stribild ® if other
treatments cannot be used (avoid initiating Stribild ® if
eGFR less than 70 mL/minute/1.73 m2
, only continue Stribild ® if potential
benefit outweighs risk (discontinue Stribild ® if eGFR less
l MONITORING REQUIREMENTS Test urine glucose before
treatment, then every 4 weeks for 1 year and then every
l PRESCRIBING AND DISPENSING INFORMATION Dispense in
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