Highlighted news stories
WHO removes three Ranbaxy antiretrovirals from prequlification list due to failings in research procedures
The World Health Organisation today announced that it has removed three antiretroviral products manufactured by the Indian company Ranbaxy from its list of prequalified antiretroviral products. Prequalification has been suspended because site visits within the past two weeks to contract research organisations that carried out bioequivalence studies for Ranbaxy revealed non-compliance with international standards of Good Clinical Practices and Good Manufacturing Practices.
Isoniazid prophylaxis halves risk of death for children with HIV in South Africa
Isoniazid treatment for prevention of active tuberculosis (TB) in children significantly reduces the risk of death in HIV-positive infants and small children according to results of a South African study presented as a late breaker on the final day of the Fifteenth International AIDS Conference in Bangkok.
[NOTE: This topic will be the subject of a special issue of HIV & AIDS Treatment in Practice within the next month].
News from the Fifteenth International AIDS Conference, Bankok
Is paying for treatment affecting adherence in Africa?
Making patients in impoverished countries contribute towards the cost of their antiretroviral treatment is one of the major causes of non-adherence to treatment according to presentations earlier this month at the Fifteenth International AIDS Conference in Bangkok.
Tenofovir and efavirenz show promise as a two drug maintenance regimen
A maintenance regimen involving only two antiretroviral drugs appears to be just as good as a traditional three drug HAART regimen at controlling viral load and boosting CD4 cell count, according to interim data from a French study presented to the Fifteenth International AIDS Conference in Bangkok earlier this month.
Once-daily regimens improve adherence and treatment satisfaction
Once-daily HAART regimens are just as potent as twice-daily regimens and significantly improve patient adherence and satisfaction, according to a Spanish study presented as a poster to the Fifteenth International AIDS Conference in Bangkok last week. The study investigators stress that their study was undertaken before several newer once-daily drugs and formulations were available. They would therefore expect the reduced pill burden associated with these new drugs to make antiretroviral therapy even easier, further improving adherence and possibly efficacy.
Fewer pills means better adherence, says Spanish study
Switching from a protease inhibitor-based HAART regimen to an efavirenz-based regimen led to a significant improvement in the level of adherence in a Spanish cohort of patients, according to a poster presentation to the Fifteenth International AIDS Conference in Bangkok last week. Although investigators identified several baseline characteristics in their cohort associated with poor adherence, the only factor which investigators could identify as associated with the observed improvement in adherence was the lower pill burden of the efavirenz regimen.
Botswana: more testing, but men still reluctant
Zoë Warwick of the Chelsea and Westminster Hospital in London presented the Bangkok International AIDS Conference with an analysis of HIV testing at the clinic she has been working at in Tutume, a town of 15,000 people in the north-east of the country.
Four days of Combivir reduces risk of nevirapine resistance from PMTCT treatment
Giving zidovudine and lamivudine for four days after birth of their babies to mothers who have received single dose nevirapine during labour significantly reduces the risk that they will develop resistance to nevirapine, and may preserve their future treatment options, a South African study has found.
Heterosexual anal sex and first sexual exposure associated with high rates of HIV transmission in African youth
Young Africans are becoming infected with HIV through unprotected anal sex between men and women, and often on their first sexual encounter, according to two presentations at the Fifteenth International AIDS Conference in Bangkok. The two studies, presented in a 'late breaker' session on the conference's final full day, support calls for earlier educational interventions, to reduce the spread of the virus.
Fluconazole doubles nevirapine levels, greatly increasing risk of liver toxicity
Researchers from South Africa have discovered that the anti-fungal drug fluconazole doubles nevirapine levels, leading to a significantly higher incidence of drug-related adverse events, including nevirapine-related liver toxicity. The findings were presented in an oral session at the Fifteenth International AIDS Conference in Bangkok.
Nevirapine liver toxicity associated with CD4 percentage over 25% and genetic factors, rash alone with genetic factors only
Australian researchers presented late breaking research on the final working day of the Fifteenth International AIDS Conference in Bangkok that suggests a combination of genetic factors and a CD4 percentage over 25% leads to the liver toxicity associated with the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine. They also found that rash alone is associated only with slightly different genetic factors.
Thai nevirapine study reports final results
Providing mothers and newborns with a single dose of nevirapine, in addition to AZT treatment, significantly reduces the rates of mother-to-baby transmission of HIV, according to the final results of a study conducted in Thailand and published in the July 15th edition of the New England Journal of Medicine. However, the women who received the single dose of nevirapine were less likely to achieve a viral load below 50 copies/ml when they subsequently started a nevirapine-based HAART regimen, according to a study involving the same population published in the same edition of the NEJM. Nevertheless, no difference was seen in CD4 cell gain or mortality between the women provided with single dose nevirapine during labour and the women who subsequently started HAART.
Cumulative time on HAART increases health risks to both mother and foetus
On the final working day of the Fifteenth International AIDS Conference in Bangkok, Spanish researchers reported a new, unexpected side-effect of HAART in HIV-positive pregnant women. They found an increasing rate of pre-eclampsia - a rapidly progressive condition found only in pregnant women characterised by high blood pressure and the presence of protein in the urine - and foetal death, and associated the increased risk with time on HAART prior to pregnancy.
Citrus juices inactivate HIV; researcher defends investigation as possible microbicide
In an in vitro study by Roger Short of the University of Melbourne presented at a poster at the Fifteenth International AIDS Conference In Bangkok, a solution containing 20 per cent lemon or lime juice was found to inactivate 90 per cent of HIV reverse transcriptase activity within two minutes. A phase I safety study of using citrus juices as topical microbicides is now planned.
Treatment for children must become global priority, urges MSF
Treatment for children for HIV needs to become an international priority for advocates and governments said Médecins Sans Frontières (MSF) director Daniel Berman yesterday at the Fifteenth International AIDS Conference.
Pilot study finds weekend breaks from HAART may be possible on NNRTIs
An intriguing study presented on the second day of the Fifteenth International AIDS Conference examining the feasibility of intermittent therapy taken five days a week, with two consecutive days off, has found that it may indeed be an option for those taking non-nucleoside-based HAART, although the strategy appears much riskier for those on protease inhibitors. However the researchers emphasise that the results are preliminary and that the strategy should not be adopted without careful discussion between doctor and patient.
Low risk of serious kidney toxicity on tenofovir, but mild renal dysfunction cause for concern
Five different cohort studies presented this week at the Fifteenth International AIDS Conference in Bangkok have found that the risk of kidney toxicity on Gilead's nucleotide analogue, tenofovir (Viread), is extremely rare in individuals who initiate the drug with normal renal function. However, a sixth study, using more sensitive measurements than the other five, found that tenofovir is associated with mild renal dysfunction, which may subsequently make the kidneys more susceptible when tenofovir is co-administered with nephrotoxic drugs.
CD4-guided treatment interruptions safe and cost-effective, Thai study shows
The final results of a small Thai study have shown that using CD4 cell counts to guide treatment interruptions is a safe way to reduce the time on therapy - and its cost - while maintaining good virological and immunological responses. These findings were presented today at the Fifteenth International AIDS Conference in Bangkok.
Could monotherapy with Kaletra become an option for HIV treatment?
The protease inhibitor lopinavir boosted with ritonavir (Kaletra) could become a viable option for monotherapy in treating HIV-infection in treatment-naïve patients or in patients wishing to simplify a successful antiretroviral drug regime, according to a range of studies presented this week at the Fifteenth International AIDS Conference in Bangkok.
Abstinence debate finds more consensus than difference
What is the importance and place of promoting abstinence from sex and illicit drug-taking, as distinct from harm-reduction measures like condom promotion and clean needle provision? Although a debate at the Fifteenth International AIDS Conference in Bangkok was described publicly by UN Secretary General Kofi Annan as "irrelevant", it still drew a substantial audience on the meeting's first day. The billing, "CNN vs ABC", implied a clash of US broadcasters and was deftly mediated by an anchor from CNBC Asia, Bettina Chua, who presents a programme called Squawk Box from her base in Singapore.
Initiating HAART with any one of four 3 x 5 drug choices leads to longest survival in San Francisco
Attendees at a fascinating, but flawed, presentation at the end of the first day of the Fifteenth International AIDS Conference in Bangkok heard that San Franciscans with an AIDS diagnosis at some point between 1980 and 2002, and who initiated HAART with efavirenz and 3TC alongside either AZT or d4T, survived longer than those taking any other possible HAART regimen that was available prior to 2002. Individuals taking nevirapine with either of the nucleoside analogue backbones also had significantly better survival than patients who received PI-containing regimens.
WHO: we are still on track for 3 x 5 HIV treatment goal
Despite pessimistic warnings from critics last week, the World Health Organisation announced yesterday that it is only 60,000 short of its July 2004 target for getting people onto treatment.
Efavirenz can be used at normal dose with rifampicin, Thais report
In people with lower body weight the use of efavirenz at the normal 600mg dose alongside the tuberculosis (TB) drug rifampicin does not appear to result in low efavirenz levels or HIV treatment failure, according to preliminary results of a randomised Thai study presented today at the Fifteenth International AIDS Conference in Bangkok.
Treatment access news
South African Medicines Control Council says don't use nevirapine alone for mums to be
South Africa's Medicines Control Council this week recommended that nevirapine should no longer be used as the sole drug in short course antiretroviral treatment to prevent mother to child transmission.
UK ramps up global AIDS funding, doubles Global Fund cash
Britain is to commit £1.5 billion over the next three years to fighting AIDS, Prime Minister Tony Blair announced today, of which £150 million will be spent on supporting orphans.
Generic fixed-dose combination pill effective, safe, and of high quality, Lancet reports
A generic fixed-dose combination of nevirapine, lamivudine (3TC), and stavudine (d4T), which is widely used in antiretroviral treatment programmes in Africa, is effective and safe, according to a study published in the July 3rd edition of the Lancet. The investigators also established that drug concentrations within fixed doses tablets were within expected values. An editorial in the same edition of the Lancet says that the study leaves no doubt about the efficacy and safety of generic fixed-dose antiretrovirals.
Glaxo SmithKline grants voluntary licenses for AZT, 3TC, to second South African company
Glaxo SmithKline this week announced that it has granted voluntary licenses for two of its antiretrovirals - AZT and 3TC - to the South African generic manufacturer Thembalami (a joint venture of the Indian company Ranbaxy and Adcock Ingram).
Final APRICOT and ACTG 5071 HIV/HCV coinfection results published
Eagerly awaited data from two major studies of hepatitis C (HCV) treatment in patients coinfected with HIV were presented at the Conference on Retroviruses and Opportunistic Infections this past February The final results from the APRICOT and ACTG A5071 trials were published in the July 29 edition of the New England Journal of Medicine.
Treatment Action Group releases policy recommendations on HIV/hepatitis C coinfection
The New York-based HIV advocacy organisation Treatment Action Group has released extensive recommendations for research and service development for the estimated 4 million individuals infected with hepatitis C in the United States and the global population of people with hepatitis C, estimated at 170 million.
Case report shows importance of expert prescribing for patients coinfected with HIV/HBV
An HIV-positive patient coinfected with hepatitis B virus (HBV) rapidly developed anaemia caused by a flare in HBV after his HAART regimen containing tenofovir (which is active against HBV), was switched to a regimen which did not include any drugs with activity against HBV, German investigators report in the July 23rd edition of AIDS. The investigators caution that this case shows that only experienced physicians should be allowed to prescribe antiretroviral drugs.
FDA warns that tenofovir has not been proven to be safe for HIV/HBV coinfection
Product labels for the nucleotide analogue tenofovir (Viread) in the US are to be changed to include a warning that the safety of the drug for the treatment of HIV and hepatitis B virus coinfection has not been established, the US Food and Drug Administration (FDA) has announced.