Named-based HIV surveillance data and
clinical records were used to identify individuals diagnosed with HIV but who
had not had immunological or virological monitoring for several months.

“HIV surveillance data can and should be
used by health departments to identify and locate PLWH [people living with HIV]
who are LTFU [lost to follow-up], and public health case-workers should
investigate such cases with the goal of re-engaging such PLWH in medical care
for HIV,” write the authors. “Such efforts are essential to any comprehensive
effort to control the HIV epidemic.”

Antiretroviral therapy means that many
HIV-positive people now have a normal life expectancy. Virologically
suppressive treatment has also been shown to significantly reduce the risk of
transmission of HIV.

However, many HIV-positive people in the
United States are missing out on the benefits of antiretroviral therapy.
Research suggests that almost half are not receiving regular medical care and
only 28% have a consistently undetectable viral load.

The situation in New York City is in many
respects similar to that seen elsewhere in the United States: 45% of people
with HIV are not receiving regular care and approximately a third are lost to
follow-up after establishing HIV outpatient care.

Concerned by this situation, investigators
in New York City used mandatory named-based HIV and laboratory reporting to
identify people lost to follow-up. These people were then contacted by
caseworkers who ascertained if they really had disengaged from medical
services and, if they had, offered assistance so regular care could be
re-established.

 Between July 2008 and December 2010, 797
people with diagnosed HIV infection but no record of clinical monitoring for
at least nine months were identified.

Caseworkers were unable to locate 113 (14%)
of these people. Of the remaining 684, 46 (7%) had moved outside New York
City, been incarcerated or had died.

This left 638 people presumed lost to
follow-up. However, caseworkers found that a third of these individuals were
currently receiving HIV care. Most of them (73%) had been
misclassified as lost to follow-up due to missing or mismatched CD4 and viral
load data.

These findings lead the investigators to
comment, “Surveillance data alone has limitations as a tool for identifying
PLWH-LTFU.”

A total of 409 people were located and
confirmed as lost to follow-up. Caseworkers
linked 77% of these individuals to care. The investigators were able to confirm
that 59% return to care, and 57% had CD4 and viral load monitoring in the
twelve months after their first return to care visit, with 48% have two or more
visits with immunological and virological monitoring during this period.

“Most PLWH-LTFU were willing to resume
care,” write the authors.

Over half the people (55%) confirmed as
lost to follow-up were men, most were black (67%), a quarter had injecting drug
use as their HIV risk factor and 64% were aged between 30 and 49 years.
Approximately a fifth reported a history of incarceration and 75% had been
disengaged from HIV care between nine and 29 months before their contact with a
caseworker.

CD4 and viral load monitoring showed that
the importance of reconnecting the participants with regular care. More than half had
a CD4 cell count below 200 cells/mm³, and three-quarters had a CD4
cell count below 350 cells/mm³. Monitoring also showed that 59% of
individuals had a first viral load level above 10,000 copies/ml and 18% had an
initial viral load above 100,000 copies/ml.

Caseworkers interviewed 161 people
confirmed as lost to follow-up about the reasons they dropped out of care. The
most commonly report reason was that they “felt good” about their health (41%).
Other frequently cited reasons included the pressure of day-to-day
responsibilities (16%), the side-effects of anti-HIV drugs (12%), depression
(11%), lack of medical insurance (10%) and not wanting to think about being
HIV positive (9%). Only a small number of participants (1 to 6%) said they had dropped
out of care because they had difficulties accessing healthcare providers or
social services.

The authors believe their findings have
implications for the control of the HIV epidemic in the US.

“Treatment-as-prevention cannot be achieved
unless most PLWH are on treatment, and currently thousands of PLWH in the US
are not fully engaged in HIV medical care many years following their HIV
diagnoses,” they conclude. “While the cost of deploying caseworkers to find
PLWH and re-engage them in care will be substantial, it must be weighed against
the cost of greater HIV-related morbidity and mortality among PLWH with
untreated HIV, and the increased potential for HIV transmission to sex
partners.”

Participants’ age made no difference to whether they
had unprotected sex, but race did. Black men were only a third as likely to
report unprotected sex in any one encounter as men of other ethnicities (odds
ratio 0.32, p 0.01).  In multivariate
analysis, however, taking age, the sexual familiarity of the partner and their
HIV status into account, this became statistically non-significant (due to factors discussed below) and the only
factor that was independently associated with non-use of condoms was having a female
partner: the minority of men who were bisexual were four times less likely to
use a condom with a woman than a man.

Although participants were in general more likely to
have sex with men of their own ethnicity than others, black men were by far the
most ‘sexually homophilous’ group, to use the researchers’ term. They were eleven
times more likely to have black partners than other racial groups. In contrast,
Latino men were three times more likely to have Latino partners than other
groups and white men two times more likely to have white partners.

Black men were 34% more likely to have unprotected sex
if their partner was older than them than if they were younger, and over twice as
likely if their partner was more than ten years older. This effect was not
moderated by the participant’s own age.  In
contrast, younger black men (under 25) were actually more likely to use condoms
than non-black men if their partner was even younger than they were. 

This was
exactly the opposite of the pattern in older, non-black gay men, who were
nearly twice as likely to use condoms with partners older than themselves than younger ones. In HIV-negative men, this would tend to reduce the risk of acquiring HIV, whereas the pattern seen in black men would tend to increase it.

In general, the number of previous
sexual encounters did not affect the likelihood of unprotected sex and, as we
said previously, black men were actually less likely to have unprotected sex,
averaged over all encounters. However, as their familiarity with sexual partners
increased, their likelihood of unprotected sex gradually increased.

Using
mathematical models to project from the actual data, the researchers found that
black men were almost four times less likely to have unprotected sex with a partner
they had never met before. The likelihood of unprotected sex became
roughly equal between ethnicities once the participant had had sex with
their partner about 20 to 30 times, and in cases where they had had sex 50 times
or more with them, suggesting a quite committed
relationship, black men were more than twice as likely to report unprotected
sex than non-black men.

May 17, 2013

HPV Vaccine May Protect With Two Doses Instead of Three

Girls between the ages of 9 and 13 were randomized evenly to receive either three doses of Gardasil (261 girls) at 0, 2 and 6 months or two doses at 0 and 6 months (259 girls). In addition, 310 young women ages 16 to 26 received the three-dose schedule. Investigators measured antibody levels at 0, 7, 18, 24 and 36 months.

Among the girls who took two doses of the vaccine, their responses to strains 16 and 18 of HPV one month after their last vaccine dose proved “noninferior,” or as good as, the responses of the young women receiving three doses. However, noninferiority to some HPV genotypes dissipated at the 24- and 36-month assessments when comparing the girls who took two doses with the girls (as opposed to the young women) who took three doses. Consequently, the investigators concluded that more study is needed before recommending a dose reduction as a matter of policy.

To read the MedPage Today story, click here.

To read the JAMA abstract, click here.

To read an accompanying JAMA editorial questioning two-dose vaccines, click here.

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What is Eldis?

Eldis is an online information service providing free access to relevant, up-to-date and diverse research on international development issues.

Eldis includes over 30,000 summaries and links to free full-text research and policy documents… More…

While Islam allows for difference of opinion, and the religious leaders disagree on many social issues, most orthodox Muslim scholars are vehemently opposed to homosexuality. However there are many progressive Muslim scholars with varied positive opinions about gender and sexual orientation. This discussion paper urges human rights organisations and policy makers to create a database of progressive religious leaders and lobby for their support.

The discussion paper includes 13 key recommendations for consideration of human rights organisations and defenders, gender activist and policy makers, including:

• develop an understanding that it is necessary, when working on MSM and transgender issues in countries where there is a Muslim context, to incorporate a theological approach in their work
• use positive religious text in media (TV, radio, blogs, publications) to oppose harsh orthodox approaches that are not respectful of human rights and choice of lifestyle
• provide training to relevant stakeholders, including health service  providers, on how to best work with MSM and transgender people  within a Muslim context
• develop programmes for Muslim religious leaders on HIV and MSM to influence and encourage positive messaging during Friday congregational prayers
• develop strategies to reach those who are not openly MSM so that they can be empowered with research and Islamic information on sexual orientation and gender through training and educational programmes.

May 16, 2013

Heavy Drinking Linked to HIV Transmissions

At the study’s baseline, the median number of drinks per week the men reported was eight, with the middle two quartiles ranging between two and 16 drinks. Thirty percent of the participants reported multiple partners with whom they had unprotected receptive anal intercourse over the previous two years. During more than 35,870 person-years of follow-up, 529 of the men contracted HIV.  

The researchers deduced that moderate drinking, defined as an average of one to14 drinks per week, was associated with a 10 percent increased likelihood of seroconversion compared with men who did not drink. There was a 61 percent greater likelihood for those who drank heavily, meaning more than 14 drinks per week.

Among the heavy drinkers, those who reported an average of one or fewer partners with whom they had unprotected receptive anal in the prior two years had a 37 percent greater likelihood of seroconverting compared with men who didn’t drink, and those with more than one unsafe sex partners had a 96 percent increased likelihood of contracting HIV.

The investigators concluded that interventions to reduce heavy drinking should be integrated into existing HIV prevention efforts.

To read the study’s abstract, click here.

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Brighton Hove is the area of the UK with the highest
HIV prevalence after London. The analysis was presented to the British Association of
Sexual Health and HIV (BASHH) conference in Bristol yesterday.

Since 2008, UK testing guidelines produced by sexual health
and HIV specialists have urged
healthcare workers of all specialities to consider HIV testing in a wide
range of situations and settings, including GP surgeries and most hospital
departments. In 2011, the National Institute for Health and Clinical Excellence
(NICE) issued
recommendations which endorse large parts of the 2008 guidelines.

However, health professionals from other specialities have
not always supported the guidelines and implementation has been patchy. Only a
few parts of the country are likely to have results as encouraging as Brighton
Hove.

HIV clinicians there, led by Martin Fisher of Brighton
Sussex University Hospitals NHS Trust, have placed a strong emphasis on
expanding HIV testing in recent years. There have been numerous educational
interventions for non-specialist clinicians, service innovations and research
studies.

General practitioners have been trained to recognise the
symptoms of primary HIV infection and are offered free HIV testing kits. Pilot
projects have attempted to make HIV testing universal for new patients admitted
to hospital and in primary care. A pilot has demonstrated the merit of
automatic prompts for HIV testing when a ‘clinical indicator disease’ is
recorded in the electronic patient record system.

Rapid testing has been in offered in community settings,
such as gay bars, a gay sauna and Terrence Higgins Trust premises. A walk-in sexual
health service has been opened next to Brighton station.

The data presented to the BASHH conference concern positive
test results (rather than all tests conducted) in Brighton Hove between
2000 and 2012. During that time, 1359 people have been diagnosed, predominantly
men who have sex with men (72.9%) and people of white ethnicity (77.1%).
Nonetheless, 15% of diagnoses have been in women.

In 2000, three-quarters of diagnoses were made in the
‘traditional’ settings of sexual health clinics, antenatal clinics and blood
transfusion services. However, since 2010, a majority of diagnoses have been
made elsewhere – in 2012, 57.8% were made in ‘non-traditional’ settings.

Diagnoses made by general practitioners have increased from
2.7 to 21.2% (p0.001). Those made in community settings have risen from 0
to 12.9% (p0.001).

Hospital outpatient diagnoses have increased to a lesser extent, and
the proportion of diagnoses made in inpatient settings has actually
dropped slightly. However, actual numbers of diagnoses were not shown, so it is
possible that this is an artefact of increased diagnoses elsewhere.

Late diagnosis rates have gone down. In 2000, 52% of newly
diagnosed people had a CD4 cell count below 350/cells³, with this
dropping to 33% in 2012. The reduction in late diagnoses was most marked in the group of patients diagnosed through sexual health
clinics.

The number of people diagnosed with recent infection
(infection within the past year) has increased from 24.3 to 45.2% (p=0.005),
as did the proportion testing with symptoms of seroconversion (16.7 to 55.3%,
p=0.011). These improvements have been driven by testing in general practice,
with GPs now being more aware of symptoms.

Clinicians also seem to be increasingly aware of the
possibility of HIV infection in older people. The proportion of people over the
age of 50 who are diagnosed outside of sexual health clinics has steadily
increased from around half in 2000 to almost all in the last two years.

The researchers say that the city’s multiple HIV
testing initiatives have been associated with changes in the settings of HIV
diagnoses. Moreover, sexual health clinicians need to work with and support
colleagues in primary care, secondary care and voluntary organisations in order to improve testing practices.

The findings of the study could have
implications for ‘test and treat’ strategies currently being proposed as a way
of controlling the ongoing HIV epidemic among gay and other men who have sex
with men (MSM) in the United States and other countries.

“Identifying acutely infected patients with
high levels of viremia has considerable benefits at the individual and
community level, and underscores the importance of educating care providers in
the recognition of ARS [acute retroviral syndrome],” comment the authors.

The study was conducted by investigators
from Fenway Health, Boston, a medical facility that provides care to approximately
20,000 patients, over a quarter of whom are men who have sex with men.

Investigators at Fenway were concerned that
only 50% of people with HIV are fully engaged in care. They wanted to see if
utilisation of healthcare facilities in the period before diagnosis with the
virus was associated with the early detection of infections and suppression of
viral load within the first year of follow-up.

People were defined as engaged with care
if they had a negative HIV test or physical examination in the 24 months before
their diagnosis. All other patients were defined as new presentations.

A review of medical records held between 2000
and 2010 identified 754 new HIV diagnoses among men who have sex with men. Some
291 of these infections involved people who had already received care at
Fenway Health.

There were significant demographic
differences between people who were already known at Fenway and those seen
for the first time at the point of their HIV diagnosis. People who were
previously engaged with care were more likely to be white (p 0.001) and
have private insurance (p 0.001) than new patients.

In terms of HIV diagnosis, existing patients
were more often diagnosed with acute infection (20 vs 8%, p 0.001) or as
a consequence of routine screening (25 vs 11%, p 0.001) than new
patients.

Linkage to specialist HIV care was more
rapid for previously engaged patients, a median of just four days compared to
64 days for men being seen for the first time. One year after diagnosis, 86% of
existing patients were still receiving follow-up compared to 79% of new
patients, a significant difference (p = 0.012).

Focusing on the 12% of patients with acute
retroviral syndrome, the investigators found that 63% of these individuals were
already known to Fenway Health. Individuals diagnosed with acute retroviral syndrome were
more likely to have been tested after a risky sexual encounter (AOR = 17.32;
95% CI, 1.81-165.67) or to present with symptoms (AOR = 191; 95% CI,
26.16-1406.4) than people who had routine testing.

Almost a fifth of men (19%) met the
criteria for an AIDS diagnosis at the time their HIV was detected. Prevalence
of AIDS at the time of diagnosis was similar among engaged (17%) and new
patients (21%). Routine screening for HIV was associated with a lower risk of
AIDS at diagnosis (AOR = 0.47; 95% CI, 0.23-0.98).

Turning to longer-term outcomes, the
investigators found that 47% of the 595 patients who were still engaged with
care after one year had an undetectable viral load at this point. This included
almost all (99%) the people who had initiated antiretroviral therapy.

Black race was associated with lower odds
of virological suppression, a finding “corroborating other concerning
observations of the continued prevalence of racial disparities with regard to
HIV prevalence, diagnostic timing and engagement in care”. The authors suggest
their study confirms “the need for further research in this area and culturally-tailored
programs to engage Black MSM in their care environments”.

The investigators conclude their research
“confirms the positive influence of engagement in primary care prior to
seroconversion on important HIV outcomes at diagnosis and within one year”.
They call for further studies and public health initiatives to “focus on more
accurately defining engagement and retention, especially as it pertains to
healthcare provisions for MSM, and on the development of HIV prevention methods
specific to MSM to reduce the high incidence of AIDS when first diagnosed with
HIV.”

While many hepatitis C patients await interferon-free
direct-acting antiviral regimens, others have advanced liver disease and need
treatment now. This group includes liver transplant recipients, as HCV almost
always recurs and infects the new liver in the absence of treatment.

Elizabeth Verna from Columbia University and fellow
investigators with the CRUSH-C study evaluated triple therapy in a cohort of
liver transplant recipients at six US centres.

The analysis included 112 patients with HCV genotype 1 (55%
with harder-to-treat subtype 1a). Nearly 80% were men, a majority were white,
the median age was 58 years and 26% had the favourable IL28B CC gene variant.
Half had previously been treated with interferon-based therapy post-transplant,
with 25% being relapsers, 27% being partial responders and 48% being null
responders. Most had moderate-to-severe fibrosis. Participants used various
immunosuppressive regimens to prevent organ rejection including cyclosporine,
mycophenolate mofetil, tacrolimus and steroids.

Participants were treated with pegylated interferon,
ribavirin and one of the first-generation HCV protease inhibitors, telaprevir or
boceprevir (Victrelis). The median
time since liver transplantation at the start of therapy was 3.7 years.

Most patients (88%) used telaprevir, almost all with a
pegylated interferon/ribavirin lead-in. (This occurred as a consequence of
adding telaprevir to an existing course of therapy.) The median duration of
treatment after starting the HCV protease inhibitor was about 36 weeks. Standard
telaprevir triple therapy lasts 12 weeks, with pegylated interferon/ribavirin
alone continued through week 24 or 48, depending on early response. People who
received an extended lead-in of 90 days or longer were included in the safety
but not the efficacy analysis.

Looking at early virological response among participants who
had reached a given treatment duration, 66% of patients had undetectable HCV
RNA at week 4 of treatment, rising to 84% at week 12. Taken together, 64% had
extended rapid virological response (eRVR) – a good predictor of treatment
success in pivotal trials of easier-to-treat patients.

Of the 43 patients who completed therapy and
had at least 4 weeks of post-treatment follow-up, 65% achieved SVR4. Among
those with eRVR, however, the SVR4 rate rose to 93%. Extent of post-transplant liver
disease played a role, with 44% of patients with advanced disease
(cirrhosis or fibrosing cholestatic hepatitis) achieving SVR4
compared with 71% of those without advanced disease.

Adverse events were common in this cohort and 11%
discontinued treatment for this reason (23% with advanced disease and 6%
without). A majority of patients used growth factors, reduced their doses of
interferon or ribavirin, or required transfusions to manage blood cell
deficiencies. About one-third had creatinine increases indicative of impaired
kidney function. One in five experienced serious adverse events that required
hospitalisation, 4% experienced liver graft rejection and 6% died during
follow-up (4% due to liver-related causes).

“High rates of eRVR are achievable with triple therapy
exceeding previous rates with [pegylated interferon/ribavirin] alone despite a
difficult to treat population,” the researchers concluded. “SVR4
rates may be lower in patients with advanced disease.”

“These results must be balanced with high rates of
[adverse events], including hospitalization, kidney dysfunction and death,”
they continued. “Improving tolerability and identifying predictors of SVR
are critical to optimizing the risks-benefits of post-liver transplant triple
therapy.”

May 15, 2013

Nanoparticles May Transport HIV Meds to the Brain

The researchers bound the drug to MENs inserted into macrophage immune cells. They then used magnetic energy to draw the drug through a cell membrane manufactured as a laboratory version of the blood-brain barrier. Next the use of a low-energy electrical current prompted the drug’s release from the nanoparticle. Tests confirmed the functional and structural integrity of the drug after its release.

To read the Miami Herald story, click here.

To read the study abstract, click here.

To read a release on the study, click here.

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