HIV Ab testing should be offered to all HBV-infected patients before initiating therapy. Risk of renal failure/impairment, elevated creatinine, hypophosphataemia & proximal tubulopathy (including Fanconi syndrome); decreases in bone mineral density; acute hepatitis exacerbation upon discontinuation of hepatitis B therapy; increase in wt & in levels of blood lipids & glucose; immune reactivation syndrome; osteonecrosis. Serum ALT may increase in some patients after initiating antiviral therapy. Tenofovir disoproxil fumarate should only be used as part of an appropriate antiretroviral combination regimen in HIV/HBV co-infected patients. Reports of mitochondrial dysfunction in HIV -ve infants exposed
in utero &/or postnatally to nucleoside analogues. Should not be administered concomitantly w/ other medicinal products containing tenofovir disoproxil fumarate, tenofovir alafenamide, adefovir dipivoxil. Not recommended w/ didanosine. Reports of early virologic failure & of emergence of resistance in HIV patients in triple nucleosides/nucleotides therapy as a once-daily regimen. Avoid concurrent or recent use of nephrotoxic medicinal product (eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2). Patients concomitantly receiving ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir & a boosted HIV PI should be monitored for tenofovir-related adverse reactions. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Limited safety & efficacy data in liver transplant patients; & in HBV-infected patients w/ decompensated liver disease & w/ Child-Pugh score >9. No data on efficacy in patients co-infected w/ hepatitis C or D virus. Reports of dizziness which may affect ability to drive & use machines. Not to be used during breastfeeding. Not recommended in paed patients. Caution in elderly >65 yr.
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