Compiled by Robert Fieldhouse
Two-year durability of T-20 demonstrated
Promising new two-year data on the first fusion inhibitor T-20 (Fuzeon) were presented at the Bangkok Aids Conference.
Until now researchers have presented compelling data showing that after 48 weeks of treatment, those receiving T-20 as well as combination therapy chosen by resistance testing were twice as likely to achieve an undetectable viral load when compared to those treated with standard combination therapy alone.
In addition, CD4 gains in the first year of therapy were twice as high among those treated with T-20 compared with those treated with conventional therapy alone.
The second year of follow-up shows that of the 661 patients randomised to T-20, 52 per cent remain on T-20.
Regimes were discontinued due to injection site reactions (7 per cent), side-effects (12 per cent) and insufficient therapeutic response (10 per cent).
More importantly, the death rate in the T-20 arm was less than one percent; this trial enrolled people with experience of an average of 12 prior antiretroviral drugs, with seven years spent on HAART, and with median CD4 88 cells when the trial began.
Just over a quarter of T-20 treated patients obtained a viral load below 400 copies at week 96. By comparison, only 13 per cent of those on conventional combination therapy alone had obtained a viral load below 400 copies at week 48.
Between week 48 and week 96 an increasing proportion of patients obtained a 100 or more CD4 cell count rise, with 37 per cent of those on T-20 reporting a 100 cell rise at week 96.
No new side-effects were identified between weeks 48 and 96 and many were reported less frequently in year two; particularly diarrhoea, fatigue, fever, oral thrush all improved further. T-20 is currently being evaluated for once daily use.
Tenofovir/FTC outperforms Combivir
Preliminary 24 week data, comparing once daily Tenofovir and FTC with efavirenz against the current ‘gold standard’ first-line combo of Combivir/efavirenz, show those treated with tenofovir were significantly more likely to obtain viral load below 400 copies.
At week 24, 88 per cent of people treated with Tenofovir/FTC/efavirenz had a viral load under 400 copies compared with 80 per cent taking Combivir/efavirenz.
CD4 gains over the first 24 weeks were similar: tenofovir/FTC, 129 cells; Combivir, 111 cells.
Those taking Tenofovir and FTC with efavirenz were less likely to drop out of the study because of side-effects. Only 3 per cent dropped out versus 9 per cent taking Combivir/efavirenz. In addition, they were less likely to report serious (grade three or four) side-effects (9 per cent compared with 15 per cent of those treated with Combivir/efavirenz).
More detailed data, including information on the proportion of people in each arm achieving viral load under 50 copies, will be presented in November.
Tenofovir and FTC will soon be available co-formulated as one pill once-a-day. The study will continue for at least 96 weeks.
Once-daily regimens improve adherence
Satisfaction and adherence to treatment are greater among those receiving all their HIV drugs together once a day, according to new data from 55 Spanish hospitals.
The findings are important because an increasing number of HIV drugs are becoming available as once daily options.
Researchers looked at 978 people on either once or twice daily HAART. They divided those receiving once daily HAART into three groups: those on their initial HAART combination, those who had switched to once daily therapy for simplification and those who had switched to once daily therapy following treatment failure.
Regardless of which group patients belonged to, satisfaction with therapy was greater among those patients on once daily HAART compared to those receiving twice daily therapy.
This study began several years ago when fewer drugs were available for once daily dosing. As more drugs have become available and will become available over the next year, the study researchers cautioned their findings saying that these newer options may improve adherence further and lead to even greater efficacy.
Resistance rise in recently infected gay men
An increasing proportion of gay men in the UK with recently acquired HIV infection have a strain with some resistance to HIV drugs, new research suggests.
Researchers for the Health Protection Agency (HPA) tested 26,000 anonymous blood samples taken for syphilis testing at 15 GUM clinics across the UK. Using an antibody test known as a ‘detuned assay’ they identified which were recent HIV infections.
In total 243 of the samples were defined as recent infections over the period 1999 to 2002.
Researchers, presenting the data at the World Aids conference in Bangkok, were able to show that drug resistance in men with newly acquired HIV had increased from 20 per cent of the samples in 2001 to 27 per cent in 2002.
Acquired resistance to protease inhibitors has fallen since 2001, in line with fewer protease inhibitors being prescribed in the UK.
Another Bangkok poster presentation from the HPA suggested that acquiring a drug resistant strain need not necessarily mean that your future treatment options were limited.
It seems only those who acquire multi-drug resistant HIV (resistance to protease inhibitors, nucleoside analogues and NNRTIs) find it hard to construct a decent first-line therapy. Very few people in the UK appear to be diagnosed with this high level of drug resistance.
Taken together, the findings underline the importance of people having a drug resistance test at first diagnosis, before beginning combination therapy, as recommended by British HIV Association guidelines.
More pre-eclampsia with HIV pregnancies
New research suggests pre-eclampsia occurs more in pregnant women living with HIV.
Pre-eclampsia, also known as pregnancy-induced hypertension (high blood pressure or toxaemia), affects five to eight per cent of pregnant women in the general population. But new research suggests rates are considerably higher in women living with HIV.
Occurring most frequently in the final trimester, high blood pressure is accompanied by protein in the urine and if the baby cannot be delivered, the condition may lead to death of the baby.
Researchers from Spain collected data from all pregnant women, HIV positive and negative, attending a Barcelona hospital between January 2001 and August 2003.
They found the rate of pre-eclampsia among women living with HIV was 11 per cent, considerably higher than the 2.8 per cent in HIV negative women. In addition, death of the baby due to pre-eclampsia occurred in 6.1 per cent of babies born to women with HIV and only in 0.5 per cent born to HIV negative women.
The researchers then looked back at the data they had on all HIV positive pregnant women from October 1985 to August 2003 and found that the rate of pre-eclampsia and foetal death had increased since the introduction of combination therapies in the late 1990s.
Longer time spent on HAART seems to increase the risk, though no specific classes of HIV drug have been associated with increasing the risk of either pre-eclampsia or foetal death. However, use of HAART before, during and after pregnancy should not be discouraged since there is strong evidence of the benefits (in the UK the HIV transmission rate from mother-to-baby is now less than one per cent).
The majority of cases of pre-eclampsia and foetal death had occurred between 2002 and 2003.
