tenofovir disoproxil (Viread)

following an abbreviated submission:

tenofovir disoproxil (Viread®)  is accepted for restricted use within NHS Scotland.

Indication under review:
HIV-1 infection - in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infected paediatric and adolescent patients aged 12 to < 18 years, with nucleoside reverse transcriptase inhibitor (NRTI) resistance or toxicities precluding the use of first line agents.

Hepatitis B infection - for the treatment of chronic hepatitis B in adolescents aged 12 to < 18 years of age with compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.

SMC restriction: to be prescribed under the supervision of specialists in paediatric infectious diseases.

SMC has previously accepted tenofovir disoproxil for use in combination with other antiretroviral agents in HIV infected patients over 18 years of age experiencing virological failure.  SMC has previously accepted tenofovir disoproxil for use in the treatment of chronic hepatitis B in adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis and in patients with decompensated liver disease.

Tenofovir disoproxil is listed in the British National Formulary for Children 2012-2013 for the treatment of hepatitis B infection and HIV infection.