Compiled by Robert Fieldhouse
Global treatment over-relies on generic formulation
Global
HIV treatment programmes are relying too heavily on the most common generic
fixed dose combo to the detriment of a substantial number of people living
with HIV.
Their over reliance on the generic d4T/3TC/nevirapine combo risks depriving
substantial numbers of an effective long-term therapy, Asian researchers have
warned.
This fixed-dose combination is often the only medication available to many
people living with HIV in Asia.
But because d4T in particular is known to cause a wide range of side effects,
a substantial number of people do not currently have alternatives to switch
to.
Researchers found that almost 40 per cent of people who stopped d4T/3TC/nevirapine
did not start any other antiretrovirals.
This group included 404 people beginning d4T/3TC/nevirapine as their first
treatment.
Around a quarter stopped therapy completely. Fewer than three per cent of
people who changed regimen switched to a protease inhibitor.
Side effects were given as the main reason for changing one or more drugs
in 20 per cent of people who started d4T/3TC/nevirapine, and by 63 per cent
of 131 who eventually stopped the combination.
The study concluded there was real need for access to affordable second-line
treatments for people living with HIV in developing countries.
In the developed world one size does not fit all, and it is possible treating
everyone with one combination only will lead to major drug resistance problems.
• HIV Medicine 2007; 8:8-16.
Gay men have better CD4 rises at London
HIV clinic...
Gay men at a London HIV clinic had better CD4 and viral load responses on
treatment compared with black African heterosexual men at the same centre.
But both groups saw improved treatment responses after July 1999.
Sixty three per cent of the people included in the analysis were gay men while
black African and ‘other ethnicity’ women formed the 17 per cent.
Ten percent were black African or ‘other ethnicity’ men; 4.3 per
cent were white heterosexual men and 5.1 per cent white heterosexual women.
The proportion taking antiretrovirals rose from 61.9 per cent in 1999 to 75.5
per cent in 2004 while the proportion taking treatment who had a detectable
HIV viral load fell from 36.9 per cent to 14.5 per cent.
There were no differences in the way women responded over all but gay men
had the highest CD4 counts at their first clinic visit and throughout the
study.
Black Africans had the lowest CD4 counts at the start and continued to have
the lowest counts despite taking HIV therapy.
• Archives of Internal Medicine 2007;167:692-700.
...but women in Spain fair better than men
Women have a significantly better response to HIV therapy than men
according to new research from Spain.
Researchers looked at data collected from 2,200 people living with HIV who
started treatment at the same time in 69 Spanish HIV clinics. Seventy-two
per cent were men.
The study looked at data over 12 months after participants started treatment
with the protease inhibitor nelfinavir (Viracept).
At every period studied over the 12 months, the women had consistently better
CD4 and viral load responses despite reporting more side effects than men.
The differences could not be explained by women being more adherent to their
treatment.
Typically the women tended to have lower viral loads and higher CD4 cell counts
when they began therapy but the differences seen in this study are more likely
explained by stronger immune responses to treatment.
• AIDS 21: 835-843, 2007
High rates of cervical infection found in positive teens
Sexually-active
teenage girls who became HIV positive from their mothers have alarmingly high
rates of cervical infections and abnormal cervical cell changes.
Researchers said it was a concern to find such high rates in adolescent girls.
But pregnancy rates in this group seemed to be lower than in the general population.
The findings came from the largest study following a group of girls up to
21 years of age living with HIV from birth.
This study is the first to report on rates of genital infections, abnormal
and potentially cancerous cells in the vagina and cervix and pregnancy in
this group.
Of 638 girls, 174 were considered sexually active. Over three-quarters were
on antiretroviral therapy.
Pelvic examinations revealed multiple cases of sexually transmitted infections
such as condyloma, trichomoniasis, Chlamydia, gonorrhoea and syphilis.
Of 101 sexually-active girls who had pap smear tests, 30 had abnormal cervical
cell changes including low and high-grade abnormal cells.
Only about half of those with abnormal cervical cells received any treatment.
Even with appropriate treatment, many cases persisted.
Thirty-eight girls became pregnant for the first time while in the study.
Seven became pregnant more than once, resulting in 32 pregnancies that ended
with live births. Only one newborn was known to be HIV positive. All who fell
pregnant and delivered live infants were on antiretroviral therapy at some
time during their pregnancy.
Researchers suggested the lower pregnancy rate was due to some girls having
severely compromised health and serious illness, making it difficult for them
to conceive.
• Am J Public Health 2007
Slower CD4 rises on AZT does not have to
spell bad news
People
begining HIV therapy with the nucleoside analogue (nuke) AZT (Retrovir) in
their combination typically have slower gains in their total CD4 count compared
with people starting with alternative nukes.
But while we tend to place a lot of emphasis on how our CD4 cells increase,
research now shows there is no evidence that a slower rise means you are more
likely to get sick.
Researchers following a large group of Swiss HIV patients and monitored CD4
counts in 1,312 people who started an AZT-containing combo (including Combivir
and Trizivir) between 1995 and 2004.
They compared this group with 865 people who started a non-AZT combination.
After two years, CD4 counts rose by an average 221 cells among people treated
with AZT and 286 cells among people treated with other nukes.
After four years respective gains were 290 and 379 cells.
But CD4 percentage improvements (the percentage of all immune cells that are
CD4 cells) were similar in both groups.
The Swiss team suggested the slower gain in absolute CD4 count with AZT could
be explained as a slower rise in total lymphocytes [immune cells] that “has
no impact on clinical efficacy”.
• AIDS 2007;21:939-946.
HIV drug market will be worth more than $10
billion by 2015
The global market for HIV drugs will grow to $10.6 billion by 2015, driven
in part by new drugs from Merck, Pfizer and Tibotec.
A recently published report said the market, worth about $7.1 billion in 2005,
will undergo significant development over the next few years.
This is because important new drug classes are likely to become available
in the coming years.
An increase in revenue from drug sales will occur regardless of a number of
patents for older HIV medications being due to expire, the report said.
The new drugs include Pfizer's CCR5 inhibitor Celsentri, due to be launched
this year, Merck's integrase inhibitor MK-0518 (Isentress) expected next year
along with Tibotec's NNRTI TMC125 followed by their other non-nuke TMC278
possibly in 2009.
TMC125 will probably be limited to late-stage use, but TMC278 is expected
to be used in early therapy and generate greater sales.
The report forecasts that TMC125 sales will hit $200 million by 2015 while
TMC278 will exceed more than $500 million.
Atripla, a co-formulation of the non-nuke efavirenz (Sustiva) with the nukes
tenofovir (Viread) and FTC (Emtriva) was developed by Gilead and Bristol-Myers
Squibb. This is expected to contribute significantly to the growth of the
global market.
Atripla has already been launched in the US where it is enjoying rapid uptake
with predicted sales heading for $1.7 billion by 2015. Its European launch
is expected later this year.
PIs do not increase risk of diabetes in
pregnancy
Protease inhibitors (PIs) are not associated with increased glucose intolerance
or insulin resistance in pregnant women living with HIV.
The ACTG 5084 study followed 149 HIV positive women during pregnancy. Seventy-six
were taking PIs and 73 were not.
They found 38 per cent had glucose intolerance. Eight per cent of the women
on PIs had gestational diabetes compared with 10 per cent of those not.
These figures are considerably higher than the expected norm of 20-25 per
cent and 2-5 per cent in the general female population during pregnancy.
However, the protease inhibitors used were not associated with glucose intolerance,
insulin resistance or adverse pregnancy outcome.
“The possibly increased rate of gestational diabetes observed in this
study population is of concern, although it may be related to population characteristics
such as high body mass index and race/ethnicity," researchers said.
• Am J Obstet Gynecol 2007;196:331.e1-331.e7
Some HIV positive kids have stable CD4 counts
into teens
More
than half of a group of 20 children born with HIV who have never taken or
received minimal HIV therapy, continue to have stable CD4 counts into adolescence.
What surprised researchers even more was their HIV viral load levels declined
as they reached their teens, according to new research.
The children were born before effective treatments for HIV became more widely
available. Nine of the 20 children saw their CD4 counts begin to fall as they
entered puberty, but in 11 children, they remained stable.
Children whose CD4 counts began to decline during puberty had no decrease
in viral load. Researchers are uncertain what causes a non-progressor to change
to a progressor and it is unknown quite how long these children will continue
to remain well.
Pill coaching help kids with HIV become healthier
Training
to help kids with HIV swallow their meds is beneficial, according to latest
research.
It allows them access to a wider range of medications, (not just those that
come in a liquid formulation), some of which may be more effective than their
current treatment.
US researchers reviewed 23 children and young people aged between 4 and 21
referred for pill-swallowing training because they were struggling to take
their medication.
A child psychologist ran the session and started by getting the children to
swallow pieces of gummy worm, followed by placebo gel caps which increased
in size. Children aged two to four years needed an average of two sessions
to learn the techniques. Older children typically needed three or more.
Six months after the training, there were significant improvement in their
adherence to their meds, CD4 count percentage, and HIV viral load. These improvements
led to better health which, noted the researchers, "was further improved
with increased adherence to a new, assumedly more potent, regimen”.
The researchers called for a randomised clinical trial of pill-swallowing
training to test whether it should be provided routinely to young children,
before "behavioral refusal observed in older children becomes an issue”.
• Pediatrics 2007;119:e893-e899
Transmitted resistance levels fall
Fewer people are acquiring drug resistance HIV on infection possibly because
potent HIV therapy is being more widely used, according to a new study.
If people on treatment have undetectable viral loads, they are less likely
to be able to transmit drug resistant HIV to people yet to start therapy.
Between 2002 and 2004 the proportion of people in the UK who acquired some
drug resistance before they started HIV treatment declined.
Researchers analysed 4,454 samples gathered between early 1996 and late 2004
including 316 tests on people with recent HIV infection.
They found rates of transmitted drug resistance in people not yet on therapy
peaked in 2001/2, when 14 per cent of the people tested had one or more major
drug resistance mutation. By the end of 2004 this had declined to eight per
cent.
In the UK, all resistance test results from routine HIV care are stored in
a drug resistance database. The number of resistance tests has increased particularly
since the British HIV Association recommended all people living with HIV should
be monitored for transmitted drug resistance before starting their first HAART
combination.
Wider use and increased adherence to therapy may explain the fall in acquired
drug resistance. Earlier estimates may also have been biased if doctors were
selecting more people whose partners were on treatment.
• AIDS 21: 1035-1039, 2007
How normalised is HIV care in the UK?
As people living with HIV live longer lives, it’s likely we will need
to access a wider range of services from clinics and primary care. But the
level of care we recieve may be compromised if doctors are unaware of our
HIV status.
Researchers asked GU doctors about the use of combined HIV clinic and general
hospital notes, and the normalisation of HIV management.
Combined notes were used by only 12 per cent of respondents, and 42 per cent
had encountered difficulties in communication that affected delivery of care
for a person living with HIV.
Centres using combined notes had better communication with other doctors and
specialties, suggesting a higher standard of care. The researchers recommended
considering combining patients’ HIV and hospital notes.
• Sexually Transmitted Infections 2007;83:151-154
