News in brief

Treatment slashes HIV infection rate

A trial designed to see if giving antiretroviral drugs (ARVs) to HIV-positive people would stop them infecting partners has been stopped nearly four years earlier than planned, because the answer was a convincing ‘yes’.

The HPTN 052 study found that HIV-positive people on ARVs were more than 20 times less likely to transmit HIV to their sexual partners than untreated people.

The study, conducted in eight countries, began enrolling participants in 2005, recruiting 1736 couples in which one partner had HIV and the other did not.

Half the HIV-positive participants, who had to have a CD4 count between 350 and 550 cells/mm³, started taking ARV drugs immediately and half waited either until their CD4 count fell below 250 cells/mm³ or they developed an AIDS-defining illness.

The investigators stopped the trial when they realised that out of 28 HIV infections seen in the HIV-negative partners where the HIV-positive partner was clearly the source, only one occurred where the positive partner was taking ARVs – a 96% risk reduction.

Starting early was better for the HIV-positive partner too: there were only three cases of TB in people who started ARVs immediately and 17 in those who delayed them.

Michel Sidibé, Executive Director of UNAIDS, said: “This breakthrough is a serious game changer and will drive the prevention revolution forward. It makes HIV treatment a new priority prevention option.”¹

The trial result has led to calls for a more evidence-based approach to global funding for HIV programmes. In The Lancet, a team of experts from many international HIV groups has called for the “discontinuation of the inefficient application of programmes to the wrong populations or without regard to their outcomes” and support solely for programmes with a “direct effect on reduction of transmission, morbidity, and mortality”.²

Vitamin D deficiency does matter

Vitamin D deficiency, very common in people with HIV, does seem to be associated with faster immune decline, two studies have found.

In a survey of 1985 HIV-positive people from Europe, Israel and Argentina, 24% of patients had vitamin D blood levels below 24 nanograms per millilitre, which is the threshold for deficiency.³

The investigators found that the one-third of patients with the lowest levels of vitamin D at the start of the study were nearly twice as likely to have progressed to AIDS ten years later and about 1.7 times more likely to die, even of non-AIDS-related causes. This risk was independent of their initial CD4 count.

Another study from the US⁴ compared 149 people with HIV and 34 HIV-negative people. Vitamin D levels were significantly higher in the HIV-negative controls. In the patients with HIV, low vitamin D levels were associated with increased inflammation, lower CD4 counts, and poorer responses to therapy.

Low levels of the vitamin were also strongly associated with hardening of the arteries; people with the worst thickening in the wall of the carotid (neck) artery were ten times more likely to have vitamin D deficiency.

The investigators say: “Our results show that vitamin D may play a role in both HIV-related cardiovascular disease and immune restoration.”

Neither of the studies, however, definitively pin down vitamin D deficiency as the cause because they cannot rule out the possibility that other issues such as lifestyle might cause both the deficiency and poorer health. The US investigators therefore urge a randomised controlled trial of vitamin D supplements for people with HIV to find out if correcting deficiency can improve health.

Commissioners explain London changes

The London HIV Consortium (LHC), which negotiates HIV drug purchasing in the capital, has explained the background to changes in HIV drug prescribing, which aim to save £8 million.⁵ London’s NHS spent over £170m on ARVs in 2009/10, 19% of the entire drug spend.

As outlined in the April issue of HTU,⁶ contracts have been signed with drug companies agreeing price reductions if certain volumes of drugs are sold. To meet these targets, the number of patients on abacavir (usually as the abacavir/3TC pill Kivexa) and atazanavir (Reyataz) need to be increased.

With abacavir, most of the increase will come from putting new patients on Kivexa rather than on tenofovir/FTC (Truvada) or the triple-drug pill Atripla, unless abacavir is contra-indicated. With atazanavir, however, a number of patients already taking other protease inhibitors (PIs) will have to be switched.

The LHC’s money-saving plan is part of a national drive to improve quality, innovation, productivity and prevention (QIPP) in NHS services. NHS trusts achieving efficiency and service targets will get funding bonuses, or will fail to get some of their expected funding if they don’t.

The LHC says: “The ARV tender process this year means that considerable savings will be made to the bill for antiretrovirals... With the clinical outcomes of a number of [ARVs] now similar, HIV doctors and patients can ensure cost-effectiveness of treatment without compromising the quality of care... and, where it is clinically appropriate to do so, will use the least expensive treatment option available.”

An audit to monitor the outcomes for patients has been started and will report every three months for two years.

The National AIDS Trust (NAT) has expressed concerns over the targets and has written to the London Specialised Commissioning Group (LSCG),⁷ the purchaser side of the LHC. NAT asks LSCG for guarantees that outcomes in patients will be audited properly by gender, age and risk group, that no-one will be switched to atazanavir without properly informed mutual agreement, and that it commits to wider discussions with people with HIV and HIV organisations when considering similar measures in future.

LSCG is also asked to confirm that clinics “will not be rewarded or sanctioned for success or failure in switching a certain number or proportion of patients to atazanavir“. This would seem to be a difficult promise to make given that the most novel aspect of this new agreement, which over 50% of London’s lead HIV consultants have already signed, is that explicit financial rewards and sanctions are part of it.

The HIV treatment advocates’ network UKCAB (www.ukcab.net) is asking Londoners who experience their HIV drugs being changed without warning or explanation to contact them, or the i-Base Treatment Helpline on 0808 800 6013.

Two new hepatitis C drugs approved

The first two protease inhibitor drugs for hepatitis C, as examined in HTU 205, have now been approved in the USA. Boceprevir (Victrelis) has already been approved by the European Medicines Agency, and telaprevir (Incivek) is likely to follow soon. Both have been approved only for treatment of the most common and hard-to-treat strain of hepatitis C, genotype 1.

A significant challenge to adopting the new drugs is their expense. US activist group, the Fair Pricing Coalition, has expressed “disappointment” in the wholesale prices of the two drugs, which are $48,000 and $49,200 for a course of boceprevir or telaprevir respectively, especially as this will set the likely price of future hepatitis C drugs. In Europe, a price of €28,000 has been suggested for boceprevir, though in practice a variety of discounts may be negotiated.