HTB

Doravirine approved by NHS England as single NNRTI and as part of FDC with 3TC/TDF

Simon Collins, HIV i-Base

On 29 November 2019, NHS England published prescribing guidelines for the access to the NNRTI doravirine. [1]

These guidelines report that there is sufficient evidence to support a policy for the routine commissioning of this treatment in line with cost-based, regional prescribing guidelines for the treatment of adults with HIV-1 who have no past or present evidence of resistance to the NNRTI class.

Where doravirine is used with a two NRTI backbone, those backbone components should be fully active.

All patients for whom doravirine is considered a treatment option must be considered in an HIV specialist treatment multidisciplinary (MDT) meeting and the decision of the MDT recorded.

Doravirine is contraindicated with drugs that are strong cytochrome P450 CYP3A enzyme inducers, because of the potential to reduce doravirine levels.

These drugs include, but are not limited to, the following:

  • Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin.
  • Androgen receptor inhibitor: enzalutamide.
  • Antimycobacterials: rifampin, rifapentine.
  • Mitotane.
  • St John’s wort (Hypericum perforatum).

Doravirine can be taken with or without food and it is available as a single pill (100 mg) and in a fixed dose combination with lamivudine and TDF.

Doravirine is marketed with the trade name Pifeltro and the doravirine/TDF/3TC FDC is marketed as Delstrigo.

comment

It is good news that doravirine is now available in England.

NICE have taken a year to review the three phase 3 studies (two in naive and one switch) that formed the basis for the European Medicines Agency in November 2018. [2]

This NHS process has therefore successfully delayed access to these new medicines by only a year.

References

  1. NHS England. Cinical Commissing Policy: doravirine for the treatment of HIV-1 in adults. NHS England Reference: 190137P. (29 November 2019).
    https://www.england.nhs.uk/publication/doravirine-for-the-treatment-of-hiv-1-in-adults
  2. HIV i-Base. Doravirine (Pifeltro) and doravirine/TDF/3TC FDC (Delstrigo) approved in Europe. HTB December 2018)
    http://i-base.info/htb/35389

Links to other websites are current at date of posting but not maintained.