From April 2011, the preferred first- and second-line drug regimens for HIV-positive people in London are changing. The change in prescribing practice will not initially affect people on current regimens but will be applied to new patients and to those who need to change to a second-line protease inhibitor-based regimen.
The two primary changes are:
- The preferred first-line regimen will change from tenofovir + FTC + efavirenz to abacavir + 3TC + efavirenz. What this means in practice is that, instead of taking one pill a day (the combination pill Atripla), most new patients will take two (Kivexa [3TC + abacavir] plus Sustiva [efavirenz]).
- If patients have to start on or switch to a protease inhibitor (PI)-based regimen, the PI initially prescribed will be atazanavir (Reyataz). Some patients taking ‘old-fashioned’ PIs may be offered a change to atazanavir.
These changes are due to a new two-year purchasing agreement between the London HIV Consortium (LHC) and the drug companies. The LHC represents the majority of London’s hospital and primary care trusts and, since 47% of people with HIV accessing care in England live in London, has considerable negotiating power when it comes to the prices paid for drugs.
Although a maximum ‘list price’ is set by each country for drugs licensed in Europe, an aspect of HIV care that gets little scrutiny is that NHS bodies – ranging from individual trusts to large consortia like the LHC – negotiate their own deals with each drug supplier. The LHC has managed over the years, due to its economic position, to pay about 25% below list price for antiretrovirals.
This year, however, primary care trusts in London told the LHC and HIV prescribers that their budget would not grow this year. This meant that hospitals needed to save £9 million on drugs in order to accommodate other HIV patient and clinic costs and not to lose services. This excluded other cost-saving measures like home delivery (which is cheaper because it does not attract VAT). Although the overall HIV spend has not been cut, the number of patients continues to increase, (a 5.3% increase in 2009 in London), and thus the amount spent on drugs had to come down.
Although in terms of cost per lives saved, HIV treatment is a cost-effective intervention, its sheer cost to the NHS these days is staggering: with a higher HIV prevalence than the rest of the country, 19% of the entire London NHS drugs budget in 2009 was spent on antiretrovirals, and 29% of the budget for specialist conditions.
The changes are based on current clinical practice and no patient will be forced to take a drug with significant side-effects or which is detrimental to their quality of life. They are also in accordance with the most recent treatment guidelines issued by the British HIV Association (BHIVA),1 although these guidelines are now three years old (new ones are planned for later this year).
They are, however, bound to cause some controversy. The biggest area of concern surrounds the use of abacavir and conflicting evidence about an increased risk of heart attack.2,3,4,5 The difference may be due to the fact that large cohort studies like D:A:D may miss a factor that impacted on both health and choice of drug regimen.
There is also some evidence – again disputed – that abacavir may not be as potent as tenofovir in suppressing HIV in patients with a high viral load (see News in Brief).6,7
Because of these concerns, tenofovir instead of abacavir will be prescribed to patients with a viral load over 100,000 copies/ml or with a high heart attack risk score.
Does having to take two pills a day impact on adherence or health? One study last year found a difference between one- and two-pill regimens, but this has not been found in other studies.8
Atazanavir does not raise blood lipids (fats) as much as other protease inhibitors and is taken as one capsule, once a day. It has been linked to kidney stones in a few patients and can cause a harmless but sometimes marked form of jaundice; darunavir (Prezista) is recommended as the alternative for people who cannot tolerate atazanavir or have resistance to it.
The purchasing agreement has been signed by London’s lead HIV consultants and holds until April 2013. It can be changed if new clinical evidence comes along that changes prescription guidelines, but it cannot now be altered if a company makes a new price offer.
The LHC, and its parent body the London Specialised Commissioning Group, can withhold all or part of the HIV drugs budget from any clinic seen to fail to achieve the cost savings expected, though commissioners stressed that this was a "final resort", and would be seeking to work in partnership with clinics to meet the requirements of the agreement.
For more information on these prescribing changes, see: http://i-base.info/home/changes-to-hiv-drug-prescribing-in-london/.
- Gazzard BG et al. British HIV Association guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy 2008. HIV Medicine 9, 563-608, 2008.
- Worm SW et al. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study. Journal of Infectious Diseases 210: 3108-30, 2010.
- Lundgren J et al. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the SMART study. XVII International AIDS Conference, Mexico City, abstract THAB0305, 2008.
- Bedimo R et al. Abacavir use and risk of acute myocardial infarction and cerebrovascular disease in the HAART era. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, abstract MoAb202, 2009.
- Ding X et al. No association of myocardial infarction with ABC use: an FDA meta-analysis. 18th Conference on Retroviruses and Opportunistic Infections, Boston, abstract 808, 2011.
- Daar E et al. ACTG 5202: Final Results of ABC/3TC or TDF/FTC with either EFV or ATV/r in Treatment-naive HIV-infected Patients. 17th Conference on Retroviruses & Opportunistic Infections, San Francisco, abstract 59LB, 2010.
- Bansi L et al. Virological response to initial antiretroviral regimens containing abacavir and tenofovir. J Infect Dis 200: 710-14, 2009.
- Meyers J et al. Adherence to antiretroviral treatment regimens and correlation with risk of hospitalization among commercially insured patients in the US. 10th International Congress on Drug Therapy in HIV Infection, Glasgow, abstract O113, 2010.