Compiled & edited by Gus Cairns
Health minister Lord Warner has approved a move to allow patients to report adverse side effects directly to the body which licenses medicines in Britain.
The minister’s action comes after an independent inquiry recommended patients should now have the right to report unpleasant or unexpected drug side effects.
Until now, only doctors have had the authority to report side effects to the Medicines and Healthcare products Regulatory Agency, which licenses drugs, and its advisory body the Committee on the Safety of Medicines.
The change follows a spate of problems with a variety of new drugs, including
HIV antiretrovirals and modern antidepressant drugs, in spite of doctors’ reports.
In the past doctors were supposed to report drug side effects and toxicities
using the yellow card system, but in a move to broaden patient power, the
Department of Health has extended the process to patients themselves.
Research has shown that problems coping with side effects such as lipodystropy, peripheral neuropathy and mental health problems are the main reasons why people with HIV stop or change treatments.
The move follows complaints that the NHS has failed to address patients’problems with drug side effects and concerns about the antidepressants Seroxat and Prozac. Martin Flynn
Final results of a study, comparing the two main non-nucleoside (NNRTI) drugs, efavirenz (Sustiva) and nevirapine (Viramune), found that efavirenz had a slightly (though not significantly) superior performance to nevirapine. The difference was small enough to be due to chance, and the choice of which drug to prescribe patients is more likely to be made on the basis of their very different side effects.
The 2NN study recruited 1,216 patients world-wide and gave them regimes containing either efavirenz once-daily; nevirapine twice-daily; a double dose of nevirapine, once-daily; or both drugs.
The proportion of people who maintained undetectable HIV viral loads was 62 per cent on efavirenz, 56 per cent on both nevirapine doses, and 47 per cent on both drugs. “Our findings show no evidence that efavirenz is superior to nevirapine,” the researchers concluded.
However, they also said they “could not show equivalence” between the two drugs. This means that the ‘real’ difference between the two drugs, allowing for statistical error, could have been anything from nevirapine being one per cent better than efavirenz, to efavirenz being 13 per cent better than nevirapine. The researchers had said they would not call nevirapine ‘equivalent’ unless there was no chance that efavirenz was over 10 per cent more effective.
Of more interest to patients than these figures are the side effects of both drugs, which can be serious.
Two people died of, or as a result of, nevirapine side effects. One died of liver failure and the other of an infection caught when hospitalised for the severe allergic reaction called Stevens-Johnson syndrome. About one in 50 patients on nevirapine developed severe live abnormalities compared with about one in 300 on efavirenz. Deaths due to efavirenz are harder to prove as the drug’s most serious side effects are psychological ones. In a commentary on the study, Professor David Cooper said that suicide attempts occured in about one per cent of patients taking efavirenz, and two to three per cent in those with previous psychiatric illness.
Intermittent low-level but detectable HIV viral loads (so-called ‘blips’) might be better for patients than having their HIV completely suppressed all the time, a US scientist suggests.
Dr Steven Deeks from San Francisco general hospital concluded that having a persistently detectable viral load, however low, on treatment, will eventually lead to much larger viral loads and falling CD4 counts. Conversely, staying undetectable all the time means staying healthy.
But having HIV that is undetectable most of the time, but that occasionally surfaces in a ‘blip’, may be best of all. ‘Blippers’ experience treatment failure scarcely more often than people who stay completely undetectable, but their immune system retains a strong HIV-specific immune response which may complement the effects of HIV therapy.
Dr Deeks studied 46 HIV patients. Of these, 13 maintained undetectable HIV viral loads; 15 were ‘blippers’ with detectable viral load tests less than a quarter of the time; and 18 had persistent viral loads that were low-level (fewer than 1,000 copies).
The majority of patients with persistent viral loads failed to control their HIV in the long run. By the end of the three-year study only 30 per cent of them had still maintained viral loads under 1,000. In contrast, all but one of the 15 ‘blippers’ (93 per cent) kept their viral load under 1000, as did all the ‘undetectables’.
However the ‘blippers’ had much stronger immune responses to HIV than the ‘undetectables’, with eight times as many of the cells that kill off HIV-infected cells.
A new report says the biggest unmet need of people living with HIV in the UK is not treatment, but counselling and mental health support.
The Psychosocial and Healthcare Needs of HIV Positive People in the UK was recently written for the British HIV Association.
The report says a key challenge facing agencies dealing with people with the virus is “to provide additional mental health support geared towards HIV as a chronic illness affecting vulnerable populations.”
It comments that support services have to become more varied and complex, because of the fragmented nature of the HIV positive community in the UK, the increasing complexity of life problems such as facing going back to work, and because of the social exclusion of people with HIV, particularly immigrants.
 Positive kids: a growing problem photo: digitalvision/posed by models |
The authors comment that “post HAART [combination therapy], HIV care has become more medicalised, and clinicians now manage the virus rather than the patient.” But in fact, the report says, healthcare providers actually need a wider range of ‘people skills’ than ever before to support people with HIV.
“ These include cultural competence to provide appropriate care to...a range of ethnic groups; understanding of social and psychological issues affecting individuals with HIV; and an understanding of stigma.”
In terms of groups that have particular needs, the report singles out immigrants; older people with HIV “who are likely to have poorer psychological health, and [may be] more severely affected by HIV stigma”; and mothers and children, where disclosure of the HIV status of either the parent or the child can be traumatic for both parties.
Forecasting that more teenagers born with HIV will soon be entering into the adult world, the report says: “HIV positive children grow up with a sense of difference and many are not fully aware of their diagnosis. HIV positive adolescents face the added challenge of negotiating sexual relationships.”
One in 40 (2.5 per cent) of UK gay men becomes infected with HIV in the course
of each year, according to the results of a study by the Health Protection
Agency (HPA).
The figure in London is one in 33, but out of London only one in 100.
These rates have remained constant since 1995 and appear unaffected by the widespread adoption of HIV therapy since then; this might have been expected to bring rates down, because it makes HIV positive people on average only a third as infectious.
The HPA calculated its figures from anonymous tests, though it could be told by means of a code if that patient had tested positive before.
This can show how many people with HIV turn up at clinics and get treated for STIs, but are not offered an HIV test.
The study found the majority of HIV positive attenders with STIs, including
gay men, were not offered an HIV test. Only a third of the recently-infected
gay men actually got diagnosed at their STI checkup; 64 per cent went away
undiagnosed, and must be presumed to form the majority of the 22 per cent
of HIV positive gay men who do not know they are infected.
The HPA’s Dr Noel Gill predicted that rising trends in unsafe sex may
push the annual incidence up further.
 Internet meets: riskier? photo: harriet nyambalirwa |
A UK study comparing men who meet online through sites like gay.com and Gaydar with men questioned in gyms has found that men making most of their contacts online are on average younger, less likely to be in a relationship, less likely to have tested for HIV, and, despite being less optimistic about HIV treatments, more likely to have unsafe sex.
Fifteen per cent of the men surveyed were HIV positive, 65 per cent had last tested HIV negative, and 20 per cent had never tested.
Online respondents were more likely to have had unprotected anal sex in the three months preceding the survey. A third had done so as opposed to less than a quarter of the gym goers.
Despite this, online men were less optimistic about HIV. Only 15 per cent of them agreed with the statement “I am less worried about HIV infection now that treatments have improved”.
