Pregnancy, breastfeeding and children

There are no safety data for the use of any DAA regimen during pregnancy, with all PBS-listed DAA regimens classed as Category B (sofosbuvir, B1; velpatasvir, B1; ledipasvir, B1; glecaprevir, B1; pibrentasvir, B1; grazoprevir, B1; elbasvir, B1; daclatasvir, B3; PrOD, B3) for their risk in pregnancy. Treatment of pregnant women with DAA therapy is therefore not recommended. It is recommended that women wait 4 weeks after treatment before becoming pregnant. All DAA regimens are contraindicated in pregnancy when combined with ribavirin (category X). As noted, ribavirin requires contraceptive precautions. People treated with ribavirin should be counselled about the risk of teratogenicity and the importance of not becoming pregnant during treatment or for 6 months after treatment.

Coadministration of ethinyloestradiol-containing medications, such as combined oral contraceptives, with the regimens of glecaprevir and pibrentasvir, as well as PrOD ± ribavirin, has been associated with serum ALT elevations. Coadministration is therefore contraindicated. For women using combined oral contraceptives, alternative DAA regimens are recommended.

The safety of the listed DAA regimens during lactation has not yet been established, and treatment of women who are breastfeeding is therefore not recommended. Children under the age of 18 years are not currently eligible for treatment with the new HCV medications under the PBS. Studies in paediatric populations are ongoing. People under the age of 18 years should be referred to a paediatrician who is experienced in the treatment of HCV for discussion about therapy.