HIV PEP Side Effects

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Answer the side-effect intent for hiv pep without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

Part of hiv & prep & arvs side effects.

What is HIV PEP?

HIV post-exposure prophylaxis covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• tenofovir — VIRLAM, Pharma Dynamics (Pty) Ltd (Film-coated tablets)
• emtricitabine — Prepetam, Austell Pharmaceuticals (Pty) Ltd (Tablet)
• lamivudine — ADCO-LAMIVUDINE 300 mg, Adcock Ingram Limited (Tablet.)
• dolutegravir — MYLTEGA, Mylan (Pty) Ltd (Film-coated tablet)

Common side effects of HIV PEP

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Tenofovir (VIRLAM)

• Blood test indicating raised liver enzyme levels
• Hives, itching, sweating
• Muscle pain
• Lack of energy, back or chest pain, pain
• Blood tests indicating abnormal levels for the following cholesterol or triglycerides, amylase (indication of pancreas infections), creatine kinase (indication of muscle damage), white blood cell count, glucose
• Blood in urine, glucose in urine as detected with urine analyses
• Low white- (symptoms include repeated fevers and infections) and red blood cell counts (symptoms include fatigue, dizziness, weakness and light-headedness, pale skin), low platelet count (symptoms include easy and excessive bruising, prolonged bleeding from cuts), abnormal organ or tissue development and function
• Exhaustion, muscle cramps body weakness due to a condition called lactic acidosis
• Inflammation of the pancreas (symptoms include upper abdominal pain, fever, nausea, vomiting)
• Inflammation of the liver (symptoms include discoloured urine and stools, diarrhoea, abdominal swelling, distention or bloating, loss of appetite)
• Kidney problems, kidney failure (swelling of your legs, ankles, and feet from retention of fluids, confusion, reduced amount of urine), nausea, drowsiness or fatigue)
• Tingling or prickling

The leaflet lists 7 more. Read the full leaflet.

Emtricitabine (Prepetam)

• Stomach pain
• Pain
• Abnormal physical weakness or lack of energy
• Diarrhoea
• Headache
• Nausea (feeling sick), vomiting
• Dizziness
• Difficulty sleeping, abnormal dreams
• Problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
• Rashes (including red spots or blotches sometimes with blistering and swelling of the skin which may be allergic reactions), itching, changes in skin colour including darkening of the skin in patches Blood tests may also show:
• Low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• Increased triglycerides (fatty acids), bile or sugar in the blood

The leaflet lists 12 more. Read the full leaflet.

Lamivudine (ADCO-LAMIVUDINE 300 mg)

• Nausea, vomiting, stomach pain or cramps, diarrhoea
• Unusual weakness or tiredness
• Fever, general feeling of illness
• Difficulty in sleeping
• Headache, sensation of pins and needles, tingling, burning, numbness
• Muscle pain or cramping
• Joint pain
• Cough, irritated or runny nose Side effects with frequency unknown:
• Loss of hair Side effects that may show up in your blood tests:
• A reduction in the number of white blood cells (neutropenia)
• A reduction in the number of platelets (cells that make the blood clot) (thrombocytopenia)
• A reduction in the number of red blood cells (anaemia)

The leaflet lists 3 more. Read the full leaflet.

Dolutegravir (MYLTEGA)

• insomnia (difficulty in sleeping)
• headache
• dizziness
• abnormal dreams
• nausea
• diarrhoea (frequent and watery bowel movements)
• vomiting
• flatulence (excessive gas/ wind)
• upper abdominal pain
• pruritus (an intense itching sensation)
• fatigue (temporary loss of strength and energy)
• depression

The leaflet lists 5 more. Read the full leaflet.

Serious side effects and warning signs

None of the leaflets reviewed set out a separate serious-effects list.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

Cautions from each medicine’s approved leaflet.

Tenofovir (VIRLAM)

Do not use it at all if:

• if you are allergic (hypersensitive) to lamivudine or tenofovir, or any of the other ingredients in VIRLAM
• if you have moderate to severe impairment of kidney function
• if you are pregnant or breastfeeding
• if you are younger than 18 years of age
• if you Are taking zalcitabine

Use with care, and tell your doctor, if:

• you have symptoms such as deep, rapid breathing, drowsiness, and non-specific symptoms, such as nausea, vomiting and stomach pain
• This is a serious, life- threatening side-effect known as lactic acidosis (excess of lactic acid in your blood). Lactic acidosis occurs more often in women, particularly if they are very overweight. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with VIRLAM, please report any of these symptoms to your doctor as a matter of urgency
• you have hepatitis B virus (HBV) infection
• you have a kidney disorder. Please report to your doctor immediately if you develop swelling of the lower limbs, hands, body or face, are short of breath and if you pass very little or no urine. You may have to go for regular blood tests to monitor your kidney function
• you develop excess fat on your abdomen (stomach), behind your neck, or your breasts may enlarge, while your legs and arms become thinner. Contact your doctor as soon as possible if you notice changes in body fat distribution. You may require blood tests to monitor your cholesterol and blood sugar (glucose) levels
• you develop severe stomach pain or cramps accompanied by fever, chills, and severe nausea and vomiting

Emtricitabine (Prepetam)

Do not use it at all if:

• if you are hypersensitive (allergic) to tenofovir disoproxil, emtricitrabine or any of the other ingredients of PREPETAM (listed in section 6)
• If you are pregnant or breastfeeding
• If you have kidney problems or are on dialysis
• If you are already taking any other tenofovir or emtricitabine containing medicines or medicines containing lamivudine because these medicines contain the same or similar active ingredients
• If you are a female who is taking PREPETAM to prevent HIV infection and you become pregnant while taking PREPETAM
• If you are HIV positive or if your HIV status is not known, when using PREPETAM to prevent HIV infection

Use with care, and tell your doctor, if:

• If you have bone problems
• If you have liver problems including Hepatitis B Virus infection
• If you have had kidney problems in the past or take other medicines that can cause kidney problems
• If you are taking other medicines as PREPETAM may interact with these other medicines
• If you are also infected with the Hepatitis B Virus (HBV), you need close medical follow up for several months after stopping treatment with PREPETAM. Follow-up includes medical examinations and blood tests to check for HBV that could be getting worse
• Patients with Hepatitis B Virus who take PREPETAM and then stop it, may get “flare-ups” of their hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. PREPETAM is not approved for the treatment of Hepatitis B Virus infection. You should read the

Lamivudine (ADCO-LAMIVUDINE 300 mg)

Do not use it at all if:

• If you are hypersensitive (allergic) to lamivudine or any of the other ingredients in ADCO- LAMIVUDINE 300 mg TABLETS (listed in section 6.1)

Use with care, and tell your doctor, if:

• If you are pregnant or breastfeeding
• If you have, or previously have had, a hepatitis B infection of the liver. ADCO-LAMIVUDINE 300 mg TABLETS may make the infection worse
• If you develop stomach pain, nausea or vomiting. Check with your doctor, as these could be signs of an inflamed pancreas
• It may result in a condition called lactic acidosis. If you are feeling unwell, consult your doctor
• Liver disease has been known to occur
• If you have kidney disease

Dolutegravir (MYLTEGA)

Do not use it at all if:

• if you are hypersensitive (allergic) to dolutegravir or any of the other ingredients of MYLTEGA (listed in section 6)
• if you have liver disease or if your liver is not functioning normally
• if you are taking a medicine called metformin (this medicine is used for diabetes – lowering of sugar levels in the body)
• if you are taking medicines called dofetilide and pilsicainide (these medicines are used to treat abnormal rate of muscle contractions in the heart)
• if you are pregnant or breastfeeding your baby

Use with care, and tell your doctor, if:

• If you get any rash as it may be an indication that you are having an allergic reaction. You should stop taking MYLTEGA and contact your doctor immediately if you get other symptoms of an allergic reaction such as fever, fatigue, muscle or joint aches, blisters, sores in your mouth, swelling of your feet or face
• If you get any other symptoms of other serious infections, usually due to your already weakened immune system. When you start treatment you may find that old, hidden infections (such as tuberculosis) flares up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight against these infections
• If you notice that there is a change in the distribution of fat throughout your body e.g. a hump forming on your back, loss of fat from your face, collection of fat around your abdomen
• If you experience joint aches and pains, stiffness in your joints or any difficulty with movement, it may be an indication that your bones are being damaged
• If you are taking any other medicines even if they are non-prescription. However do not stop taking MYLTEGA without your doctor’s advice
• MYLTEGA is not a cure HIV infection, it only reduces the amount of virus in your blood therefore HIV can still be transmitted while you are taking MYLTEGA. You should therefore use condoms during intercourse

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

Related pages

• HIV PrEP side effects

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