Compiled & edited by Gus Cairns
 Novir’s price (left) goes up sixfold: |  Kaletra’s (right) doesn’t |
Drug manufacturer Abbott Laboratories has given a 500 per cent price hike to its HIV drug ritonavir (Norvir®). One 100mg capsule of Norvir used to cost $1.48. It will now cost $8.55.
US Aids activists ACT-UP New York reacted angrily to the decision, calling it ‘“an outrage and a slap in the face to the HIV community as a whole.”
The price of Abbott’s other HIV drug Kaletra® - a co-formulation that includes ritonavir alongside another drug, lopinavir - has not risen.
Ritonavir has the unique property of boosting the levels in the body of other HIV protease inhibitors that would be too weak to work alone, and this pricing decision means that Kaletra will be considerably cheaper than other ritonavir-boosted PIs, including atazanavir and fosamprenavir, which have just come on the market, and the salvage drug tipranavir, which will arrive next year.
“This would lead one to assume,” says ACT-UP, “that this is purely a marketing ploy to push for a larger market share for Kaletra.”
“That’s not true,” Laureen Cassidy, Abbott’s US Director of Public Affairs, told Positive Nation. “We don’t need to do that because Kaletra already has the biggest market share of the PIs.
“The issue is that when Norvir was licensed it was as a 10 or 12 capsules a day single PI. It is now only being taken as a booster of one or two capsules.
“We also wish to finance a process that will enable us to turn Norvir into a solid pill that won’t need to be refrigerated.”
But US doctors echoed Aids activists’ concerns. Dr Daniel Kuritzkes, vice-chair of the HIV Medicine Assocation, in a letter to Abbott, said: “We are alarmed by your decision to raise the cost of protease inhibitor regimes to the point where many people...won’t have access to them at all.”
And Dr Benjamin Young of the University of Colorado said: “I find the...increase in the cost of Norvir is offensive and a direct assault on the freedom of patients to access their best possible treatment options.”
A European spokesperson for Abbott said there were no plans to increase the price of Norvir in the UK.
Pre-exposure prophylaxis (PREP) may be an idea whose time has come at last. It means that you take a single HIV drug, not to treat it, but to stop you catching it in the first place.
Trials of PREP are already taking place among heterosexuals in five African countries: Cambodia, Ghana, Cameroon, Nigeria and Malawi. Another among Cambodian prostitutes has just started.
Now the US Centers for Disease Control has announced that they will grant $3.5m to fund two studies of PREP among highly sexually active gay men in Atlanta and San Francisco.
The same drug is being used in all these trials: tenofovir (Viread®). Manufacturer Gilead was far-sighted enough back in 1995 to give tenofovir to HIV negative monkeys, who then successfully fought off infection via a shot of HIV.
One of the things researchers will be investigating is whether people given PREP will feel they can abandon condoms altogether. This might wipe out any gains in reducing HIV infection and, since PREP is HIV-specific, won’t prevent people catching gonorrhoea, syphilis, or any of the other sexually-transmitted infections.
l There will be a full report on PREP in Positive Nation’s 100th issue, out next month.
Keep an eye on IRIS
Patients starting HIV therapy are being warned to watch out for Immune Reconstitution Inflammatory Syndrome (IRIS), which is caused by the immune system recovering and suddenly killing off infected cells. This leads to symptoms that mimic an original illness. A study has now found that IRIS affects up to a third of patients who start therapy. Nearly 60 per cent of infections causing IRIS symptoms were genital herpes infections, and nearly 10 per cent were of shingles. A quarter had renewed outbreaks of genital warts. There were two cases of ‘revived’ hepatitis B and one of Kaposi’s sarcoma. Researchers concluded that IRIS is mainly likely to involve viral infections from the herpes family, and is particularly likely to manifest itself in skin conditions. |
The new protease inhibitor atazanavir (Reyataz®) has been approved for licensing in Europe. However the European Union’s Committee for Proprietary Medicinal Products (CPMP) only gave the go-ahead for its use in patients who have failed at least one previous regime, and only when its levels in the body are ‘boosted’ by ritonavir (Norvir®- see story opposite). The dose will be two 150mg tablets once a day plus a 100mg ritonavir capsule.
In contrast the US has licensed atazanavir for all patients, and it doesn’t have to be ritonavir-boosted (the unboosted dose is two 200mg tablets once a day).
At first sight the CPMP decision seems an odd one: “I think it’s daft,” was the comment of one treatment activist. Others were concerned that the restrictive licence granted to atazanavir might give an excuse for bodies issuing drug guidelines carte blanche to omit it from a list of approved drugs.
Atazanavir does not produce the rises in blood fats (lipids) seen with the other protease inhibitors. The addition of ritonavir might increase lipids, removing one of atazanavir’s main advantages. It has however been found that even when atazanavir is combined with ritonavir, lipid rises are still lower than those seen with other protease inhibitors.
Test tube studies predicted that if patients became resistant to atazanavir, they would actually become somewhat more sensitive to other protease inhibitors. The reverse is not the case. At first sight, this would appear to indicate that the drug would make a better first-line therapy.
‘Real life’ trials, however, found that when patients failed on atazanavir, only 10 per cent of them actually acquired the kind of resistance that made them hypersensitive to other protease inhibitors. Most acquired complex patterns of PI resistance that meant they might fail other PIs too.
Recent studies have also cast doubt on unboosted atazanavir’s performance when compared with the other new-generation protease inhibitors. A study comparing patients on (unboosted) atazanavir with patients on Kaletra found that Kaletra slashed the average HIV viral load 100-fold, but atazanavir only 40-fold.
 Being in a couple is good for you, say Aids researchers photo: Getty images |
Bad news for introverts and bachelors. A small study has found that gay men with HIV who displayed shyness traits such as ‘introversion, social avoidance and emotional inexpressiveness’ were dramatically more likely to have high viral loads and develop Aids than more socially adjusted men.
And a larger study in the British Medical Journal found that single HIV positive people were 21 per cent more likely to develop Aids than people in stable relationships.
The singles-versus-couples study researchers could not pin higher sickness levels to a single cause, and could only guess at the influence of factors like depression and alcohol.
But the research into the shy men points to a specific culprit: higher levels of stress hormones.
The study looking at relationships was a large one. 3736 Swiss people with HIV were studied, of which 29 per cent were women.
80 per cent reported being in a stable relationship at some point during the five years of the study but only 46 per cent were actually in one at the end of the study, with older people less likely to have steady partners. For every 100 single people in the study who developed Aids symptoms or died, only 79 people in relationships did.
The ‘shy men’ study only looked at 54 gay men, so its results may not be as reliable. But it found that viral load was eight times higher in men judged to be socially inhibited than in others, and that they were eight times more likely to fail antiviral therapy if taking it.
Dr Steve W Cole of the University of California, Los Angeles concluded that no less than 64 per cent of the poor viral control in the stressed people was due to high levels of the fight-or-flight hormone norepinephrine (adrenaline) in their system.
“A shy, socially sensitive temperament has long been associated with increased vulnerability to infectious disease,” Dr Cole told Reuters Health.
