Dolutegravir and Truimeq approved in England
29 January 2015. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 14 January 2015, NHS England published the long awaited policy on dolutegravir and the fixed dose combination (FDC) of dolutegravir/abacavir/3TC (Triumeq). [1]
The NHS policy states two reasons why dolutegravir has the potential to improve care:
Firstly, that it reduces levels of HIV virus in the body quickly. This is the main aim of HIV treatment.
Secondly, that it causes fewer side effects than some other HIV drugs. This includes a much lower risk of common side effects such as mood changes, depression, anxiety, disrupted sleep and suicidal thoughts. Overall, this means the treatment is better tolerated and improves patient safety.
The evidence for these benefits came from large randomised studies. Studies looking at switching people on stable therapy are still ongoing.
The guidelines detail situations when dolutegravir can be prescribed, both for treatment-naive and -experienced patients.
1. Patients unable to tolerate first line therapy
- Patients who are not suitable for or who do not tolerate efavirenz based first line therapy due to demonstrated toxicity, intolerance, adherence, treatment failure or resistance as agreed in the multi-disciplinary team (virtual clinic). Dolutegravir is a treatment option for this patient group.
- This policy recommends that where dolutegravir is used, it should be combined with the lowest cost, clinically indicated backbone.
- The cohort of patients requiring alternative to first-line therapy is expected to be no more than 30% of the total treated patient cohort. Dolutegravir is now one of the options for these patients.
2. Patients failing treatment and those with resistance
- Dolutegravir is approved for use in patients requiring an integrase inhibitor due to recorded treatment failure or resistance.
- In treatment experienced and integrase inhibitor naïve patients at a dose of 50mg daily.
- In treatment experienced and integrase resistant patients at a dose of 50mg twice daily.
London prescribing guidelines were also updated on 14th January to include the new recommendations for doultegravir and Triumeq. [2]
Comment
It is good that NHS executives finally agreed that specialised services clinical commissioning policies approved for publication will be available on the NHS England website. However, this has involved a long and protracted review process given that the European Medicines Agency (EMA) approved dolutegravir almost a year ago. [3]
A lot of people involved in providing HIV care worked hard to help this review and feedback to policy drafts from various stakeholders hopefully helped this process.
Dolutegravir was approved in Scotland in May 2014. [4]
Triumeq was approved in Europe in September 2014. [5]
References:
- NHS England. Clinical Commissioning Policy: Dolutegravir for treatment of HIV- 1 in adults and adolescents. Reference: NHS England B06/P/a. January 2015.
http://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-b/b06
http://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2015/01/b06-dolutgvr-trt-hiv.pdf (PDF) - London Therapeutic Tender Implementation: Guidance for Clinical Use.14 January 2015.
https://i-base.info/wp-content/uploads/2015/01/London-NHSE-guidance-14Jan2015.pdf (PDF) - ViiV Healthcare press statement. ViiV Healthcare’s new HIV medicine Tivicay (dolutegravir) is approved in Europe. (21 January 2014).
http://www.viivhealthcare.com/media.aspx
http://www.scottishmedicines.org.uk/SMC_Advice - ViiV Healthcare press statement. ViiV Healthcare receives EU marketing authorisation for Triumeq. (03 September 2014).
http://www.viivhealthcare.com/media.aspx