Although experience with PrEP during breastfeeding is lacking, there is substantial experience with the use of TD*/FTC during the breastfeeding period by HIV-positive women taking TD*/FTC based antiretroviral therapy. TD* and FTC are secreted in breast milk, although at much lower concentrations (0.3 and 2%, respectively), of the levels achieved with the doses recommended for the treatment of infants with HIV infection (30). In the PrEP setting, a study evaluating antiretroviral excretion in breast milk and infant absorption suggests PrEP can be safely used during breastfeeding with minimal infant drug exposure (28).

If a woman acquires HIV infection during breastfeeding, the risk of transmission to her infant is higher than in an established infection, because of high viral load soon after seroconversion. Therefore, PrEP can be continued during breastfeeding in women at risk of HIV acquisition.

The ASHM Contact Tracing Guidelines Panel will continue to monitor the safety of TD*/FTC PrEP regimens when used during pregnancy and breastfeeding.

Patients with chronic active HBV infection

Both TD* and FTC are active against HIV and hepatitis B virus (HBV) infections. They may prevent the development of significant liver disease by suppressing HBV replication. Only TD*, however, is currently approved for this use in Australia. Therefore, ongoing treatment with TD*/FTC may be especially indicated in people with active HBV infection who are also at risk of HIV acquisition.

Of note there are two case reports of patients who were receiving TD* for treatment of hepatitis B and who acquired HIV infection (31). Plasma levels of tenofovir and prescription refills suggested that the patients’ medication adherence was good. These guidelines recommend that people with established hepatitis

B infection who require treatment for hepatitis B infection receive combined TD*/FTC and have ongoing monitoring for HIV PrEP and hepatitis B infection.

All people who test positive for hepatitis B surface antigen (HBsAg) should be evaluated by a clinician experienced in the treatment of HBV infection. For clinicians without this experience, co-management with an infectious disease or liver specialist should be considered.

People living with chronic HBV infection should be tested for HBV DNA by the use of a quantitative assay to determine the level of HBV replication before PrEP is prescribed, and at regular intervals (e.g. every 3–6 months) while taking PrEP (32). TD* presents a very high barrier to the development of HBV resistance.

However, it is important to reinforce the need for consistent adherence to the daily doses of TD*/FTC to prevent reactivation of HBV infection with the attendant risk of hepatic injury, and to minimise the possible risk of developing TD*-resistant HBV infection (33). For these reasons, on-demand PrEP is contraindicated in patients with chronic hepatitis B infection.

If PrEP is no longer needed to prevent HIV infection in a patient with chronic hepatitis B, a separate determination should be made about whether the patient requires ongoing treatment for HBV infection. Acute flares resulting from the reactivation of HBV infection have been seen in those with and without HIV infection after stopping TD* and other medications used to treat HBV infection. When people living with chronic hepatitis B elect to discontinue PrEP, they should first be evaluated by a clinician experienced in the management of HBV infection to ascertain their need for ongoing HBV treatment, and to monitor for any hepatic flares that occur if PrEP is ceased.

The Therapeutic Goods Administration (TGA) has not approved this regimen in Australia.