Question

How can I use raltegravir as first treatment in the UK?

2 August 2010. Related: Access to treatment, Adherence, All topics, Drug interactions, Resistance, Starting treatment.

Hi,

Infected and diagnosed within the last twelve months, and I’m not on meds yet. I’ve done a lot or reading and from what I can make of it all raltegravir (Isentress) plus Truvada (tenofovir+FTC) looks like a very good combination.

I meet with my consultant in September to talk about starting treatment, my preference is to start sooner than later. I know raltegravir/Truvada has been approved in the UK for first-lime treatment but am worried that my consultant may not agree to start me on it. I don’t want to start on Atripla due to the CNS issues and that I have to take it at night and two hours after food.

I have two questions;

1. If this is my preferred option and my consultant says no what if anything can I do to change his decision?

2. What are your thoughts on this combination, good and bad?

Thank you.

Answer

Answer: Simon Collins

Hi there

Thanks for sending these questions and allowing us to answer online – these are all good questions!

Firstly, everything about treatment is individual. Without more details about your current CD4 count, viral load and history, I can only talk in general terms. There may be specific reasons why some combinations would be better or worse for you that your doctor would know more about.

Although the UK guidelines currently recommend efavirenz+Truvada (the drugs in Atripla) as the preferred first-line combination, there are lots of alternative combinations that are more appropriate for some people. Many people do not use efavirenz (includuing Atripla) because of the side effects, so you are not alone here.

People who do not want to chance the side effects from efavirenz, usually start with a boosted protease inhibitor. Atazanavir/ritonavir has the advantage of being once-daily, though it is taken with food.   If your CD4 count is under 400, you could also consider nevirapine. Although this is more rarely used now, it can be taken with or without food, and although it is twice-daily (after the first two-weeks which are once-daily), many people are currently taking this as a once-daily drug.

Although raltegravir is now approved in the US and Europe as part of a first-line combination, access issues are difficult in the UK because it costs much more than other current first-line drugs.

Pricing issues are complicated in the UK because each Trust negotiates it’s own price for each drug. While it is ridiculous that this is not worked out for the NHS on a national basis, the current situation means that relative drug prices may be different in different regions.

In London for example, where cost of other durgs are reduced from bulk purchasing, the London HIV consortium have decided that raltegravir is too expensive compared to other first-line options. So in London, raltegravir will only be funded for specific patients, generally those with multiple drug resistance of other health complications (chemotherapy interactions, transplant recipients etc). The benefits of a better side effect profile are not currently thought to justify the significantly higher costs. I don’t know the situation in Manchester, but I would expect it to be similar.

As for how the combination looks, the study results from the raltegravir studies showed it was as effective as efavirenz, but with a better side effect profile in terms of no mood disturbance/nightmares/anxiety etc and that it also had a better lipid profile. Raltegravir can be taken with or without food, but currently requires twice-daily dosing (once-daily studies are ongoing).

So far there have been now significant new side effect concerns  Raltegravir as a recent drug, has less long-term results. So far it looks very good, but without more people using the drug, it is difficult to know if and when other low-level side effects may appear, or indeed whether it will continue to be as promising.

There is much more data available to support the other current first-line options. so it is probably safer to at least try these first and keep raltegravir for if you need it later due to drug resistance.

Finally, in terms of access in the UK, you unfortunately do not have a right to chose a free combination if this falls outside the prescribing guidelines for your Trust.

The options for access then include:

• moving your healthcare to a Trust where this drug is available. If you can find one, then you have the right to access HIV care at any clinic of your choice.
• consider joining a study where raltegravir is available (for example, if your CD4 count is over 500, you could join the START study).
• pay for raltegravir privately.

Best wishes