Kivexa restored to first-line status in final British guidelines - but with cautions

Kivexa has been restored as “an appropriate nucleoside backbone” for patients starting anti-HIV treatment in the finalised version of the British HIV Association’s treatment guidelines. The published version of the guidelines also confirm the recommendation that anti-HIV treatment should be started by all patients with a CD4 cell count below 350 cells/mm³.

Draft British treatment guidelines were issued for comment in April and were reported here on aidsmap.com.

Both the draft and final version of the guidelines recommend that individuals starting anti-HIV therapy for the first time should do so with efavirenz (Sustiva) and Truvada (tenofovir and FTC). But the draft guidelines had relegated Kivexa (3TC and abacavir) to an alternative to Truvada. This was due to concerns that abacavir may be less effective in patients with a high viral load. There were also concerns about the apparent link between treatment with abacavir and an increased risk of heart attack in D:A:D study.

But the final version of the guidelines have restored Kivexa as an equal first choice with Truvada. The guidelines stress that Kivexa should only be used by patients who are confirmed to be HLA-B*5701-negative. They also go on to note that Kivexa, “in view of recent data” should be “used with caution in those with baseline viral loads over 100,000 copies/ml and in those with a significant risk of cardiovascular disease. This advice may change when more detailed study data becomes available.”

The finalised version of the guidelines also contain the recommendation that anti-HIV therapy “should be recommended in all patients with a CD4 cell count 3.” The draft version of the guidelines included a somewhat softer recommendation that treatment should be initiated at this time.

Treatment for patients with CD4 cell counts above 350 cells/mm³ “may be started or considered”, say the guidelines, in patients with any of the following characteristics:

• An AIDS diagnosis or HIV-related co-morbidity.
• Coinfection with hepatitis B virus when anti-hepatitis B treatment is needed.
• Coinfection with hepatitis C virus in some cases when anti-hepatitis C treatment is deferred.
• A low CD4 cell percentage (e.g. below 14%, a situation when PCP prophylaxis would be needed).
• Patients with cardiovascular disease or significant risk factors for cardiovascular disease (e.g. Framingham risk of cardiovascular disease of 20% over ten years).

There has been considerable debate in recent months about the impact of antiretroviral therapy on the infectiousness of HIV-positive individuals. The final version of the BHIVA guidelines includes a cautious acknowledgement that successful anti-HIV treatment has the potential to cut the risk of HIV transmission.

They state: “it is likely that successful antiretroviral treatment, by reducing viral load, reduces infectivity irrespective of current CD4 count and this may be taken into account on deciding the timing of starting treatment, particularly in discordant couples where the infected partner has a high viral load. This is likely to be an issue in a very small number of patients, and it must be stressed that antiretroviral treatment in this context would be an adjunct rather than an alternative to safer sex.”

The Canadian province of British Columbia recently announced a policy of expanding the coverage of anti-HIV treatment as a way of curbing the spread of the virus.

The full version of the new BHIVA guidelines can be read here.