Lopinavir and ritonavir

Date: May 2020, Version 1

What is it?

Lopinavir/ritonavir is an antiviral medicine for the treatment of HIV. It is also being used in clinical trials to treat coronavirus (COVID-19).

Is it safe to use lopinavir/ritonavir in pregnancy?

When deciding whether to use lopinavir/ritonavir during pregnancy it is important to weigh up the potential benefits to your health and wellbeing against any possible risks to you or your baby, some of which may depend on how many weeks pregnant you are. Your doctor or specialist will be able to help you make decisions about your treatment.

What if I have already used lopinavir/ritonavir during pregnancy?

If you are taking any medicines while pregnant, you can discuss this with your doctor. You can then decide together whether ongoing treatment is appropriate, and if so, your doctor will ensure that you are taking the most effective dose.

Can using lopinavir/ritonavir in pregnancy cause birth defects in the baby?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

Around 3,000 women have used lopinavir/ritonavir in pregnancy. While there are no concerns that lopinavir/ritonavir causes birth defects, ongoing research is needed.

Can using lopinavir/ritonavir in pregnancy cause miscarriage stillbirth, preterm birth, or my baby to be small at birth (low birth weight)?

There is no information on the chance of miscarriage in women taking lopinavir/ritonavir.

There is no evidence to suggest that stillbirth is more common following treatment with lopinavir/ritonavir.

Preterm birth and low birth weight may be more common in babies exposed to lopinavir/ritonavir. However, the effects of HIV infection in the mother may have contributed to this. Further research is needed in this area.

Can using lopinavir/ritonavir in pregnancy cause learning and behavioural problems in the child?

Brain development continues throughout pregnancy. Medication taken at any stage of pregnancy could potentially affect a child’s learning or behaviour.

Exposure to lopinavir/ritonavir does not seem to affect a child’s learning and behaviour, according to one study that followed children up to the age of 13 years. Further research is ideally required to support this finding.

Will my baby need extra monitoring?

As part of routine antenatal care, women will be offered a scan at around 20 weeks of pregnancy to look for any problems and to check the baby’s growth. Use of lopinavir/ritonavir in early pregnancy does not require extra monitoring. Women with conditions that lopinavir/ritonavir is used to treat are likely to be more closely monitored during pregnancy to ensure that they remain well and that their baby is growing and developing as expected.

Are there any risks to my baby if the father has taken lopinavir/ritonavir?

There is currently no evidence that lopinavir/ritonavir used by the father can harm the baby through effects on the sperm, and most experts agree that this is unlikely.

Who can I talk to if I have questions?

If you have any questions regarding the information in this leaflet, please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org.

How can I help to improve drug safety information for pregnant women in the future?

Our online reporting system (MyBump Portal) allows women who are currently pregnant to create a secure record of their pregnancy, collected through a series of questionnaires. You will be asked to enter information about your health, whether or not you take any medicines, your pregnancy outcome and your child's development. You can update your details at any time during pregnancy or afterwards. This information will help us better understand how medicines affect the health of pregnant women and their babies. Please visit the MyBump Portal to register.

General information
Sadly, miscarriage and birth defects can occur in any pregnancy.

Miscarriage occurs in about 1 in every 5 pregnancies, and 1 in every 40 babies are born with a birth defect. This is called the ‘background risk’ and happens whether medication is taken or not.

Most medicines cross the placenta and reach the baby. For many medications this is not a problem. However, some medicines can affect a baby’s growth and development.

If you take regular medication and are planning to conceive, you should discuss whether your medicine is safe to continue with your doctor/health care team before becoming pregnant. If you have an unplanned pregnancy while taking a medicine, you should tell your doctor as soon as possible.

If a new medicine is suggested for you during pregnancy, please make sure that the person prescribing it knows that you are pregnant. If you have any concerns about a medicine, you can check with your doctor, midwife or pharmacist.

Our Bumps information leaflets provide information about the effects of medicines in pregnancy so that you can decide, together with your healthcare provider, what is best for you and your baby.