Tools to help identify clinically appropriate HIV patients for TAF-based regimens, according to NHS England1

Disclaimer: TAF, in the context of HIV and this educational document, refers to the co-formulated combinations outlined at the bottom of this page.TAF is not licensed for use as a single agent for the treatment of HIV infection and needs to be used in conjunction with other antiretrovirals.LINKS TO PRESCRIBING INFORMATION CAN BE FOUND AT THE BOTTOM OF THIS PAGEWhat are the reimbursement criteria for TAF-based regimens, according to NHS England policy?How are clinically appropriate patients identified for a TAF-based regimen?Which TAF-based regimens could benefit your patients with definite or relative contraindications to TDF?Which MDT processes may be required for patients switching to a TAF-based regimen?

 

What are the reimbursement criteria for TAF-based regimens, according to NHS England policy?1

  • Three TAF-based products are reimbursed by NHS England for use in clinically appropriate patients1,2
  • NHS England has issued a commissioning policy which defines the following groups as potentially clinically appropriate for the use of TAF:1 

  • Based on clinical advice, NHS England estimates that currently around 20-30% of patients on a TDF-containing regimen could potentially benefit from switching to a TAF-containing regimen2

* For whom ABC is not suitable. ABC should be considered as an alternative to TDF unless there are specific contraindications (HLA-B5701 positive status, cardiovascular disease or high estimated risk of cardiovascular disease in accordance with BHIVA guidelines, need for tenofovir-containing ART in HBV co-infected individuals).1

Click here to see the NHS England TAF Policy

Disclaimer: This hyperlink links to a website maintained or controlled by others. Gilead is not responsible for and does not routinely screen, approve, review or endorse the contents of or use of any of the products or services that may be offered at this website.

 

How are clinically appropriate patients identified for a TAF-based regimen?

 

Renal contraindicactions to TDF1,3

 

For patients with CKD, the clinical criteria for TAF is based on the NICE classification for CKD and risk of CKD progression1,3

NHS England use the NICE classification of renal disease to define patients with renal contraindications to TDF:3

Adapted from NHS England Clinical Commissioning Policy 16043/P and NICE Clinical Guideline CG182.1,3

Click here to see the nice CKD guidelines

Disclaimer: This hyperlink links to a website maintained or controlled by others. Gilead is not responsible for and does not routinely screen, approve, review or endorse the contents of or use of any of the products or services that may be offered at this website.

Bone contraindications to TDF1

Osteoporosis is defined by the World Health Organisation as a BMD of 2.5 standard deviations below the mean peak mass (average of young healthy adults) as measured by DEXA and reported as a T-score:†5

 

 

Adapted from WHO Technical Report Series 921.5

† Since the distribution of BMD in the population is normal, the proportion of women affected by osteoporosis at any one site increases markedly with age in much the same way as fracture risk increases with age.5

Which TAF-based regimens could benefit your patients with definite or relative contraindications to TDF?6-8

Patients currently receiving TDF who meet the clinical criteria for switching to TAF could be considered for Descovy®,

or a Descovy®-based STR:6–8

Descovy® is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents

(aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).6

Genvoya® is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.7

Odefsey® is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤100,000 HIV-1 RNA copies/mL.8

CLICK HERE FOR PRESCRIBING INFORMATION

 

Which MDT processes may be required for patients switching to a TAF-based regimen?1

* For whom ABC is not suitable.1
† MDT discussion not required if the switch is cost-neutral or cost-saving.1

Important points to consider when prescribing the Descovy®-based portfolio:6

  • The safety and efficacy of Descovy®-based products in patients co-infected with HIV & HCV/HBV has not been established. It should not be co-administered with medicines containing tenofovir disoproxil (as fumarate), lamivudine or adefovir dipivoxil for treatment of HBV infection
  • Patients with chronic hepatitis B/C treated with antiretrovirals (ARVs) are at an increased risk for severe and potentially fatal hepatic adverse reactions

  • Discontinuation of Descovy®-based products in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment

  • Descovy®-based products should not be initiated in patients with creatinine clearance (CrCl) <30 mL/min as no data is available. It should be discontinued in patients with CrCl that declines <30 mL/min during treatment

  • Resistance testing and/or historical resistance data should guide the use of Descovy®-based products, for example Descovy® should be avoided in antiretroviral-experienced patients with HIV-1, harbouring the K65R mutation

  • The co-administration of Descovy®-based products is not recommended with certain anticonvulsants, antimycobacterials, boceprevir, telaprevir, St. John’s wort and HIV PIs other than atazanavir, lopinavir and darunavir

  • Consult the relevant Summary of Product Characteristics before prescribing (Descovy®, Odefsey® or Genvoya®)

Additional important points to consider when prescribing Genvoya®7

  • Genvoya® should not be co-administered with other ARVs
  • Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate. Increased plasma concentrations of medicinal products that are metabolised by CYP3A are observed on co-administration with cobicistat

  • Consult the Genvoya® Summary of Product Characteristics before prescribing

Additional important points to consider when prescribing Odefsey®8

  • Odefsey® should be taken once daily with food
  • Odefsey® should not be co-administered with medicines that significantly affect rilpivirine concentrations – see summary of product characteristics for more information

  • Odefsey® should be used with caution when co administered with medicinal products with a known risk of Torsade de Pointes

  • Consult the Odefsey® Summary of Product Characteristics before prescribing

If you would like more information on TAF-based regimens
please email

Abbreviations

ABC, abacavir; ACR, albumin to creatinine ratio; ART, antiretroviral therapy; ARV, antiretroviral; BHIVA, British HIV Association; BMD, bone mineral density; c, cobicistat; CKD, chronic kidney disease; CrCl, creatinine clearance; CYP, cytochrome P450; DEXA, dual-energy X-ray absorptiometry; eGFR, estimated glomerular filtration rate; EVG, elvitegravir; FRAX, fracture risk assessment tool; FTC, emtricitabine; HBV, hepatitis B virus; HCV, hepatitis C virus; HLA, human leukocyte antigen; MDT, multidisciplinary team; NHS, National Health Service; NICE, National Institute for Health and Clinical Excellence; NNRTI, nonnucleoside reverse transcriptase inhibitor; NOGG, National Osteoporosis Guideline Group; PI, protease inhibitor; RNA, ribonucleic acid; RPV, rilpivirine; SmPC, Summary of Product Characteristics; STR, single-tablet regimen; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarateDisclaimer: Some of these hyperlinks link to websites maintained or controlled by others. Gilead is not responsible for and does not routinely screen, approve, review or endorse the contents of or use of any of the products or services that may be offered at these websites.

References

  1. NHS England. Clinical Commissioning Policy: Tenofovir Alafenamide for treatment of HIV 1 in adults and adolescents. 16043/P. Available at: https://www.england.nhs.uk/commissioning/wp-content/uploads/2017/03/f03-taf-policy.pdf. Accessed April 2017.
  2. Data on file – Gilead Sciences Ltd – HIV-UK-16-04. Specialised Commissioning circular – 25 November 2016.
  3. NICE clinical guideline. Chronic kidney disease in adults: assessment and management (CG182). Available at: https://www.nice.org.uk/guidance/cg182. Accessed April 2017.
  4. NOGG: National osteoporosis guideline group: Osteoporosis – clinical guidelines for prevention and treatment. Updated Jan 2016. Available at: https://www.shef.ac.uk/NOGG/NOGG_Executive_Summary.pdf Accessed April 2017.
  5. NICE Clinical Knowledge Summary. Osteoporosis – prevention of fragility fractures. Available at: https://cks.nice.org.uk/osteoporosis-prevention-of-fragility-fractures#!backgroundsub. Accessed April 2017.
  6. SmPC Descovy®. Available at: https://www.medicines.org.uk/emc/medicine/31764 and https://www.medicines.org.uk/emc/medicine/31765. Accessed April 2017.
  7. SmPC Genvoya®. Available at: https://www.medicines.org.uk/emc/medicine/31225 Accessed April 2017.
  8. SmPC Odefsey®. Available at: https://www.medicines.org.uk/emc/medicine/32117 Accessed April 2017.

Job code: DVY/UK/17-03/MI/1069b
Date of preparation: April 2017