Fw: Hot Topics at The Body’s “Ask the Experts” Forums

From: “News at The Body” <update@news.thebody.com>
Date: 13 Mar 2012 16:38:33 -0400
To: <nelsonvergel@yahoo.com>
ReplyTo: “News at The Body” <update@news.thebody.com>
Subject: Hot Topics at The Body’s “Ask the Experts” Forums

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March 13, 2012 Visit the Forums “Hot Topics” Library Change/Update Subscription



LIVING WITH HIV/AIDS
 How Can I Make a Difference With My Life?
As a person living with HIV I feel like I’m wasting my life. Despite being a college graduate, I have not had any form of employment for the last seven years. But I know I can make a difference. How can I share my knowledge on HIV/AIDS and help raise funds for the community?

Jacques Chambers, C.L.U., responds in the “Workplace and Insurance Issues” forum

 Dear Nelson: Am I Taking a Risk Every Time I Eat Sushi?
You advised against eating raw fish, in a previous response about what type of fish to avoid. Does that mean no sushi? I eat sushi about once a month. What are the risks?

Nelson Vergel responds in the “Nutrition and Exercise” forum
Visual AIDS: Art from HIV-Positive Artists
Image from the February 2012 Visual AIDS gallery Detail from:
“Fan Earrings,” 1998
Jerome Walker

Visit the March 2012 Visual AIDS Web Gallery to view our latest collection of art by HIV-positive artists! This month’s gallery, "From Arches to Earrings," is curated by Glynnis McDaris and Julia Trotta.

INSURANCE, WORKPLACE & LEGAL CONCERNS
 Can My Niece Press Charges Against a Boyfriend Who May Have Exposed Her to HIV?
I have a niece who was dating and sleeping with a guy for about three months. They had an argument and he admitted he was HIV positive. If he is indeed HIV positive, are there actions that can be taken against him, like charging him with attempted murder, because they did have unprotected sex?

Christa Douaihy, Esq., responds in the “Legal Issues and HIV” forum

 Should HIV-Positive Health Professionals Inform Their Employers About Their Status?
Is disclosing required in order for a health professional to practice? Where can I find more information?

Jacques Chambers, C.L.U., responds in the “Workplace and Insurance Issues” forum

More Questions About Insurance, Workplace & Legal Concerns:

HIV/AIDS TREATMENT
 Could My Med Switch Be Causing My Fatigue?
I was on Truvada (tenofovir/FTC), Reyataz (atazanavir) and Norvir (ritonavir) for over five years. But because of stomach issues, I had to switch out the Reyataz for Prezista (darunavir, TMC114) for about six weeks. I started getting terrible headaches, so my doctor switched me to Truvada and Isentress (raltegravir). But now I am feeling extremely tired, more than usual. Is it because of the new regimen?

Keith Henry, M.D., responds in the “Managing Side Effects of HIV Treatment” forum

 Can I Take Hallucinogenic Mushrooms With My HIV Meds?
I’m HIV positive and want to know if I can take hallucinogenic mushrooms. What are the risks? Will it affect my immune system or my health?

David Fawcett, Ph.D., L.C.S.W., responds in the “Substance Use and HIV” forum

 Is Resistance to a Regimen Inevitable?
If a person is adherent and does not get reinfected, can they still become resistant to their regimen? What have you seen in your clinical experience?

Benjamin Young, M.D., Ph.D., responds in the “Choosing Your Meds” forum
OTHER HEALTH ISSUES & HIV/AIDS
 Living With Tuberculous Meningitis: Can I Get My Concentration Back?
I have been living with HIV for 12 years, maintaining a CD4 count of 600 to 900. However, I contracted tuberculous meningitis and it has made my personality flip 180 degrees. Prior to this, I was seen as very sensible, considerate and polite. Now I have no reservations about speaking to a person I may have just met, and even go on for too long. Moreover, my attention span is shorter than ever. I used to devour books, but have only read one in the four years following my diagnosis. What can I do about this?

David Fawcett, Ph.D., L.C.S.W., responds in the “Mental Health and HIV” forum

 Lost Sex Drive: How Can I Regain My Mojo?
I am an HIV-positive 54-year-old male in a mixed-status relationship. My CD4 count is around 575 to 650 and my viral load is undetectable. But where is my sex drive? I used to love sex, but now I have little interest in it. Could it be because of my HIV meds? I am in good shape and work out three times a week. What else can I try?

Nelson Vergel responds in the “Aging With HIV” forum
Connect With Others My Boyfriend Recently Tested Positive: Should I Stay or Go Now?
(A recent post from the "My Loved One Has HIV/AIDS" board)

Two months ago, my boyfriend of four years, father of my 2-year-old daughter, was diagnosed HIV positive. After starting treatment, he is feeling great. I am negative and test regularly, but will get another test next month just to confirm.

However, I am really confused and don’t know if I can continue my life with him, knowing he is HIV positive. As for now, I love him and want to support him. Some days he feels like he should walk away and let me find someone else. I consider this sometimes, but we have a good relationship and do have a child together. Yet I’m scared to have sex even with protection. Any advice? — Obvious1

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UNDERSTANDING HIV/AIDS LABS
 What Does My CD4 Percentage of 6 Mean?
I have been off of HIV meds for over a year and just got my lab numbers back. My CD4 percentage is 6. Is this good or bad?

Benjamin Young, M.D., Ph.D., responds in the “Choosing Your Meds” forum

More Questions About Understanding HIV/AIDS Labs:

HIV & HEPATITIS TRANSMISSION
 Which HIV Meds Are Recommended as PEP?
This is the third day on my PEP (post-exposure prophylaxis) regimen, but I noticed that my doctor only prescribed me Truvada (tenofovir/FTC). Is this good enough? What are the usual PEP regimens?

Benjamin Young, M.D., Ph.D., responds in the “Choosing Your Meds” forum

 Are You Sure Hepatitis B and C Can’t Be Transmitted Through Food?
If hepatitis B and C can be transmitted through sharing razors and toothbrushes, why is it OK to share food and eating utensils? Aren’t they just as capable of transporting blood from one person to another?

Barbara McGovern, M.D., responds in the “Hepatitis and HIV Coinfection” forum
STRANGE BUT TRUE
 Can I Get HIV if There’s None To Begin With?
Can I contract HIV even though my partner is HIV negative?

Shannon R. Southall responds in the “Safe Sex and HIV Prevention” forum

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Getting HIV Out of its Hiding Places – Reports from CROI 2012

 NATAP/CROI: HIV Eradication Study by DMargolis with Cancer Drug

Here is link to webcast of the oral session at CROI called HIV Persistence, Latency, and Eradication where Dr David Margolis presented the results of the study he conducted which is discussed below:

from Jules Levin: The drug Zolinza used in this study appears to have been able to “disrupt HIV latency, a signifucant step in eradication”, flush out HIV RNA from latently infected resting CD4 cells, which is considered perhaps the major HIV reservoir that remains after successful HAART reduces & sustains HIV viral load to below 50 copies. This study has been a while in the making, years in fact, previously another drug was tried but unsuccessfully, and this drug & experiment appears to be successful, at least at first blush. It remains to be seen what the ultimate success will be in controlling HIV with this approach as well as with other approaches. So this appears to be a hopeful & successful step, but with more steps to go.

Zolinza May Help Reduce Latent HIV Reservoirs In People With HIV (CROI 2012)

aidsbeacon.com
Published: Mar 9, 2012 7:14 pm
Results from a recent small study indicate that Zolinza, a drug currently approved to treat a certain type of lymphoma, may successfully reduce the size of the latent HIV reservoir in HIV-positive adults taking antiretrovirals.
“This is a proof of concept demonstrating that latency can be targeted. This is a significant step towards eradication of HIV infection,” said Dr. David Margolis, a professor of medicine at the University of North Carolina at Chapel Hill and lead author of the study.
“The ability of this drug to deplete latent infection remains to be established and would be the next immediate goal of our work,” he added.
Dr. Margolis urged more research into the ability of Zolinza and other drugs to eliminate or reduce the latent HIV reservoir as a regular part of HIV infection management.
The results were presented yesterday at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
Latent HIV is HIV that is not actively replicating. Instead, it lies dormant, often in immune system cells with long lifespans, such as memory cells (cells that “remember” bacteria and viruses from past infections so they can be effectively fought again). Since antiretroviral drugs usually work by blocking replication, they do not work on latent HIV.
Eradicating latent HIV is a top priority for scientists attempting to cure HIV, and several drugs are currently being tested for their ability to reduce or eliminate this hidden reserve of the virus.
Zolinza (vorinostat) is a histone deacetylase (HDAC) inhibitor, a type of drug currently used as mood stabilizers and anti-epileptic treatments. More recently, HDAC inhibitors have been investigated as anti-cancer agents, and Zolinza is approved to treat a type of lymphoma.
Research has shown that Zolinza successfully activates latent HIV in infected cells in the laboratory. Once latent HIV is activated and begins replicating, scientists hope it will become susceptible to elimination with antiretroviral therapy (see related AIDS Beacon news).
In this study, researchers investigated whether the drug is capable of activating latent HIV in adults whose HIV is well-controlled with antiretroviral therapy.
The study included six HIV-positive participants, each of whom received a single dose of 400 mg Zolinza. All participants had undetectable amounts of HIV in the blood.
Researchers measured the amount of HIV RNA, a marker of latent HIV, in resting CD4 (white blood) cells, a type of immune cell that is targeted by HIV and is thought to be a major source of latent HIV. The researchers measured the HIV RNA both before and within eight hours after giving the participants Zolinza.
Results showed that the amount of HIV RNA measured in participants’ resting CD4 cells increased an average of five-fold after they took Zolinza. According to the study authors, this indicates that Zolinza successfully reactivated the latent HIV in these cells.
There was no increase in the amount of HIV in participants’ blood due to the treatment.
Participants reported no serious side effects, and none of the side effects were attributed to taking Zolinza.

——————-
CROI ABSTRACT
Administration of Vorinostat Disrupts HIV-1 Latency in Patients on ART
N Archin1, A Liberty1, A Kashuba1, S Choudhary1, J Kuruc1, M Hudgens1, M Kearney2, J Eron1, D Hazuda3, and David Margolis*1
1Univ of North Carolina at Chapel Hill, US; 2HIV Drug Resistance Prgm, NCI-Frederick, MD, US; and 3Merck Res Labs, West Point, PA, US

Background:  Despite ART, proviral latency of HIV-1 remains a principal obstacle to curing the infection. Inducing the expression of latent genomes within resting CD4+ T cells is a primary strategy to clear this reservoir. While histone deacetylase (HDAC) inhibitors such as suberoylanilide hydroxamic acid (SAHA or vorinostat [VOR]) can disrupt HIV-1 latency in vitro, the utility of this approach has never been directly proven in a study of HIV-infected patients.
Methods:  HIV+ participants on ART, stably <50 copies/mL, maintained ART, and resting CD4+ T cells are obtained via leukapheresis. If an increase in the frequency of HIV RNA expression was observed following ex vivo exposure of resting CD4+ T cells to VOR, patients received 400 mg VOR at separate visits. First, VOR pharmacokinetics were measured. Then biomarker measures of HDAC inhibition in peripheral blood mononuclear cells (PBMC), and measurements of unspliced HIV gag RNA in pools of 1 million resting CD4+ T cells were quantified during VOR exposure.
Results:  Five men have been studied (medians: age 45; CD4 count 562 cells/µL; 4 years of ART). VOR has been well tolerated with no adverse events greater than Grade I, and no adverse events attributable to VOR. Measures of PBMC cellular histone acetylation, and chromatin-bound histone acetylation at the human p21 gene promoter increased more than 2-fold within 8 hours of VOR dosing. VOR PK was comparable to oncology studies with Cmax 263 ng/mL (range 204 to 301) and Tmax 2 hours (range 1 to 4). In each participant, HIV RNA levels increased significantly in pools of resting CD4+ cells obtained after VOR dosing compared to baseline measurements (mean 5-fold, range 3- to 10-fold).
Conclusions:  We measured HIV RNA expression directly within circulating resting CD4+ T cells of patients in whom viremia was fully suppressed by ART. In all patients studied thus far, a single dose of VOR rapidly increased both biomarkers of cellular acetylation, and simultaneously induced up to a 10-fold increase in HIV RNA expression in resting CD4+cells. This is the first demonstration that a molecular mechanism known to enforce HIV latency can be specifically and successfully targeted in man, resulting in readily measureable HIV RNA expression in highly purified, resting CD4+ T cells. Our study provides proof-of-concept for HDAC inhibitors as a therapeutic class to directly attack and potentially eradicate latent HIV infection, and defines a precise approach for evaluating such strategies.


Frailty & Muscle Loss Increase Mortality & Are Common in HIV+

Subject: NATAP/CROI: Frailty/Muscle Loss in HIV Increases Mortality & is Common

NATAP http://natap.org/
_______________________________________________

Frailty & Muscle Loss Increase Mortality & Are Common in HIV+

from Jules Levin at CROI Live in Seattle. This poster session is a
breakthrough in that it is identifying that muscle loss & frailty are
fairly common in HIV+ persons & they increase mortality. AND HCV & HBV
contribute to frailty in one study below.read this:

“Frailty is a significant predictor of mortality among both HIV+ and
at-risk IDU……. Impaired functional capacity is strongly associated
with lower bone density and lower muscle mass in middle-aged HIV-1+
persons……Co-morbidity Is Predictive of Muscle Strength in HIV+
Veterans: Results from the VACS Index….
Overall, 40% of SUN study participants aged ≤50 years with
well-controlled HIV infection were pre-frail or frail. The significant
association of pre-frailty and frailty with a history of opportunistic
infection suggests earlier diagnosis of HIV infection and prevention of
opportunistic infections may reduce risk for frailty…….Prevalence
of low muscle mass increases with age. The highest prevalence was found
in the 41- to 50-year age group. Predictors of FFMi change appear to be
associated with age, lipoatrophy recovery, and time. FFMi is associated
with all-cause mortality in HIV+ patients, suggesting that this
biological entity can provide prognostic information, in HIV+
patients……….We have recently demonstrated that patients with
prior exposure to nucleoside analog ARV, which inhibit DNA
polymerase-γ, accumulate acquired mitochondrial DNA (mtDNA) mutations
in skeletal muscle, in an apparent acceleration of the process seen in
normal aging. Here we explore an in vivo functional correlate in aging
HIV+ patients. Abnormalities of resting muscle pH handling have been
associated with fatigue and may contribute to functional decline in
this patient group.”

Frailty and Pre-frailty in a Contemporary Cohort of HIV+ Adults

Nur Onen*1, P Patel2, J Baker3, L Conley2, J Brooks2, T Bush2, M
Kojic4, J Hammer5, E Overton6, and SUN Study Investigators

1Washington Univ Sch of Med in St Louis, MO, US; 2CDC, Atlanta, GA, US;
3Hennepin County Med Ctr, Univ of Minnesota, Minneapolis, US; 4Miriam
Hosp, Providence, RI, US; 5Denver Infectious Disease Consultants, CO,
US; and 6Univ of Alabama at Birmingham, US

Background:  HIV+ persons can become prematurely pre-frail and frail;
however, pre-frailty prevalence and risk factors for both frail and
pre-frail states have not been fully elucidated.

Methods:  Using data from a contemporary prospective observational
cohort of HIV+ adults (SUN Study), we determined the percentages of
non-frail, pre-frail, and frail participants at the most recent study
visit by the respective presence of 0, 1 to 2, and ≥3 of 5 established
frailty criteria as shown in the table. We evaluated associations with
pre-frailty/frailty using logistic regression analysis.

Results:  Of 308 SUN Study participants assessed—79% men, 58%
non-Hispanic white, median age 47 years (interquartile range 41 to 53),
95% on combination ART, median CD4 cell count 650 cells/mm3 (IQR 467 to
799), and 93% HIV RNA <400 copies/mL—57% were non-frail, 38% pre-frail,
and 5% frail 
(61%, 36%, and 4%, respectively, among the 199 [65%]
participants aged ≤50 years). Prevalence of frailty criteria are
presented in the table; exhaustion and physical inactivity
predominated.
 In multivariate analysis, pre-frail/frail vs non-frail
participants were more likely of non-white race/ethnicity (54% vs 33%;
adjusted odds ratio 3.24; 95% confidence interval 1.78 to 5.91), to
have had an AIDS-defining opportunistic infection (35% vs 15%; aOR
2.55, 95%CI 1.29 to 5.02), to have poorer median perceived health
scores on the SF-12 health survey
 (1, IQR 1 to 2 vs 2, IQR 1 to 3; aOR
2.12, 95%CI 1.49 to 3.03), to have higher median PHQ-9 depression
scores (6, IQR 2 to 11 vs 3, IQR 0 to 5; aOR 1.11, 95%CI 1.04 to 1.18)
and to be older (median age 48 years, IQR 44 to 54 vs 46 years, IQR 40
to 52; aOR 1.04, 95%CI 1.01 to 1.07). Lower CD4 cell count nadir,
female sex, and unemployment were not independently associated with
pre-frailty/frailty.

Conclusions:  Overall, 40% of SUN study participants aged ≤50 years
with well-controlled HIV infection were pre-frail or frail.
 The
significant association of pre-frailty and frailty with a history of
opportunistic infection suggests earlier diagnosis of HIV infection and
prevention of opportunistic infections may reduce risk for frailty.
Racial disparities warrant further investigation.
——————-

Low Muscle Mass in HIV+ Patients: Prevalence, Predictors, and Clinical
Implication

Giovanni Guaraldi*1, S Zona1, A Silva2, G Orlando1, F Carli1, A
Santoro1, N Crupi2, G Ligabue1, C Mussi1, and L Ferruci3

1Univ of Modena and Reggio Emilia, Italy; 2Hosp de Joaquim Urbano,
Porto, Portugal; and 3Natl Inst on Aging, NIH, Baltimore, MD, US

Background:  In HIV+ patients, muscle mass measured as fat free mass
index (FFMi = FFM/h2) in DXA has never been characterized in large
epidemiological cohorts. We aimed:  to describe the prevalence of low
muscle mass using t- and z-score, per age decades, defined as <–2 SD
from the mean FFMi for an Italian Caucasian population, respectively,
for the same age or in the age strata 30 to 39 years; to identify
predictors of FFMi change; and to assess the association between FFMi
and all-cause mortality in a large HIV+ cohort.

Methods:  This observational prospective study included all consecutive
patients from 2005 to 2011 who underwent at least 2 DXA scans,
performed 1 year apart. Univariate and multivariable longitudinal
linear regressions were built to evaluate FFMI change-associated
factors. Co-variates included in the models were:  age, sex, body mass
index (BMI), physical activity; change in leg fat percentage (assessed
with DXA), in visceral adipose tissue (VAT), and in total adipose
tissue of the abdomen (TAT) (assessed with abdominal CT); NRTI, NNRTI,
and PI cumulative exposure; CD4 nadir and recovery; vitamin D plasma
level; and time between DXA scans. A Cox model was built to predict the
impact of FFMi on all cause mortality after adjustment for age and sex.

Results:  A total of 1696 HIV+ patients (1046 men) were analyzed.
Median observation follow-up period was 3.5 years (IQR 2 to 5); 96% of
patients were on ART, and during the follow-up period 37 died. BMI
change and FFMI change appeared stable over time (ß = 0.001, p = 0.111;
ß = 0.001, p = 0.070, respectively). In men, the prevalence of low
muscle mass using t- and z-scores was 0.2% and 8.5%, respectively
. In
women, the prevalence of low muscle mass using t- and z-scores was 0%
and 1.5%, respectively. The highest prevalence of low muscle mass was
detected in the 41- to 50-year age group strata (t-score 0.5% and
z-score 16%). Predictors of FFMi change were:  age (ß = –0.01, p =
0.002), change of leg fat percentage (as a surrogate for lipoatrophy
recovery) (ß = –0.05, p <0.001), and time between DXA scans (ß = 0.17,
p = 0.013). FFMi was associated with all-cause mortality (HR 0.87,
95%CI 0.78 to 0.98) after adjustment for age and sex.

Conclusions:  Prevalence of low muscle mass increases with age. The
highest prevalence was found in the 41- to 50-year age group.
Predictors of FFMi change appear to be associated with age, lipoatrophy
recovery, and time
. FFMi is associated with all-cause mortality in HIV+
patients, suggesting that this biological entity can provide prognostic
information, in HIV+ patients.
———————

Frailty Predicts Mortality in a Cohort of HIV+ and At-risk IDU

Damani Piggott*, A Muzaale, S Mehta, T Brown, S Leng, and G Kirk

Johns Hopkins Univ, Baltimore, MD, US

Background:  Frailty, a syndrome of diminished physiologic reserve with
increased stressor vulnerability, predicts hospitalization, disability,
and mortality in older HIV– adults. We have previously observed a
significant association between frailty and HIV+, particularly advanced
HIV infection, among injection drug users (IDU). In this study, we
evaluated the impact of frailty on mortality in a cohort of aging HIV+
and at-risk IDU.

Methods:  Frailty was assessed biannually from 2005 to 2008 among
current and former IDU in the ALIVE cohorts and was defined by the
presence of ≥3 of 5 standard criteria:  weakness (grip strength), slow
gait speed, weight loss, low physical activity, and exhaustion. Cox
proportional hazards models with time-varying co-variates were used to
estimate the risk (hazard ratios with 95% confidence intervals) for
all-cause mortality among frail persons relative to their robust
counterparts (defined by the absence of any criteria) and to non-frail
persons.

Results:  For 1230 subjects at baseline, the median age was 48 years,
89% were African American, 418 (34%) were female, and 351 (29%) were
HIV+. The prevalence of frailty was 9%, while 31% met no frailty
criteria. In Cox multivariable analysis of 3365 person-visits,
increasing age and HIV status were associated with increased mortality
risk.
 Adjusting for age, race/ethnicity, gender, educational level, and
HIV status, frail persons had a 3.4-fold increased risk of death
relative to robust persons
 (HR 3.42, 95%CI 1.66 to 7.03). In stratified
analysis, increased mortality risk with frailty was observed among both
HIV– persons (HR 2.91, 95%CI 1.06 to 7.96) and HIV+ persons (HR 4.05,
95%CI 1.39 to 11.8). Controlling for advanced HIV infection (CD4 <350,
HIV RNA+), frailty remained a significant predictor of mortality (HR
3.13, 95%CI 1.25 to 7.82). In comparison to non-frail persons, similar
associations of frailty with mortality were observed.

Conclusions:  Frailty is a significant predictor of mortality among
both HIV+ and at-risk IDU
. Frailty provides prognostic information even
when accounting for advanced HIV disease suggesting that standardized
assessment may inform prediction of significant clinical endpoints.
Further exploration of the biological mechanisms and clinical utility
of frailty may aid management of aging HIV+ persons.
————————

Mitochondrial Function in vivo in Aging HIV+ Patients

Brendan Payne*1,2, M Trenell2, K Hollingsworth2, J Baxter3, V Lee4, E
Wilkins3, A Price1, and P Chinnery2

1Royal Victoria Infirmary, Newcastle upon Tyne, UK; 2Newcastle Univ,
Newcastle upon Tyne, UK; 3Northern Manchester Gen Hosp, UK; and
4Manchester Royal Infirmary, UK

Background:  We have recently demonstrated that patients with prior
exposure to nucleoside analog ARV, which inhibit DNA polymerase-γ,
accumulate acquired mitochondrial DNA (mtDNA) mutations in skeletal
muscle, in an apparent acceleration of the process seen in normal
aging. Here we explore an in vivo functional correlate in aging HIV+
patients.

Methods:  We recruited older HIV+ patients in clinical care (n = 24;
age 48 to 74 years) and age-matched controls (HIV–). Phosphorus
magnetic resonance spectroscopy (31P-MRS) was performed using a 3-T
scanner. Spectra were obtained from gastrocnemius/soleus at rest and
during recovery from brief exercise. Key measures were:  adenosine
triphosphate (ATP) production during recovery (as Qmax (ADP), maximal
rate of adenosine diphosphate (ADP) clearance; τ1/2 (PCr), half-life of
phosphocreatine); and pH handling. In HIV+ subjects, comparison was
made with cellular mitochondrial function by COX (cytochrome c oxidase)
histochemistry of lower-limb muscle biopsy.

Results:  Basal parameters of ATP metabolism differed between subjects
groups:  ADP (mean ±SD) HIV+ 10.2±0.7 mM, HIV– 9.5±0.5 mM (p = 0.001);
PCr HIV+ 41.0±15.2 mM, HIV– 30.7±2.1 mM (p = 0.003). Furthermore, basal
ADP levels in HIV+ subjects correlated with biopsy COX defect (r =
0.45, p = 0.032). In contrast, dynamic measures of ATP production
during exercise recovery were similar in HIV+ and control subjects:
Qmax (ADP) (mean±SD) HIV+ 26.6±18.6 mM/min, HIV– 23.0±10.2 mM/min; τ1/2
(PCr) HIV+ 29.9±13.4 s, HIV– 27.5±8.3 s. There was more variance seen
in the HIV+ than the HIV– group, however no disease or treatment
variable was significantly correlated with ATP production rate, nor was
cellular COX defect. HIV+ subjects showed disordered pH handling
compared with HIV– controls as evidenced by higher basal pH (mean±SD,
7.07±0.03 vs 7.04±0.02, p = 0.001) and post-recovery pH (7.09±0.03 vs
7.06±0.02, p = 0.008) but similar exertional minimum pH (6.98±0.13 vs
7.00±0.03, ns). Resting pH correlated with COX defect (r = 0.42, p =
0.044).

Conclusions:  The altered basal ATP metabolite levels in HIV+ subjects
coupled with preserved dynamic function, despite cellular mitochondrial
defects on biopsy, suggests functional compensation to an acquired
mtDNA defect, once therapy has been switched to a cleaner agent.
Abnormalities of resting muscle pH handling have been associated with
fatigue and may contribute to functional decline in this patient group.
———————–

Functional Impairment Is Associated with Low Bone and Muscle Mass in
Middle-aged HIV-1+ Persons

Kristine Erlandson*, A Allshouse, C Jankowski, S MaWhinney, W Kohrt,
and T Campbell
Univ of Colorado Denver, Aurora, US

Background:  Physical function impairment may be accelerated in the
presence of osteoporosis, obesity, or sarcopenia. HIV+ persons have
early physical impairment, but little is known about the contributions
of bone or body composition changes to impairment in persons aging with
HIV-1.

Methods:  We conducted a prospective study of 45- to 65-year-old HIV-1+
subjects who had been on ART >6 months and whose plasma HIV-1 RNA <48
copies/mL. Low functioning (LF) and high functioning (HF) subjects were
identified by deficits on both Fried’s frailty criteria and the Short
Physical Performance Battery and were matched by age, gender, and time
since HIV diagnosis. Bone, fat, and muscle were assessed by
densitometry. Osteoporosis was defined as T-score ≤–2.5, osteopenia as
T-score <–1 but >–2.5, sarcopenia as appendicular skeletal muscle index
(ASMI) <5.45 kg/m2 (female) and <7.26 kg/m2 (male). Insulin-like growth
factor (IGF)-1 and IGF-binding protein (BP)-3 were measured. Stratified
logistic regression for categorical variables and linear mixed effects
regression for continuous variables were estimated to account for
correlation within matched pairs. Body mass index (BMI), tobacco, and
nadir CD4+ T cells were adjusted in models of bone loss.

Results:  We identified 30 LF and matched them to 48 HF subjects; mean
age 52.7 years, CD4 T cell 598, 96% HIV-1 viral load <48 copies/mL, 18%
female, 77% white, 17% Hispanic. LF and HF were similar in age,
duration of ART, tenofovir use, and CD4 T- cells (all p >0.2). LF
subjects had significantly lower BMD and T scores at the hip and spine;
differences remained significant in multivariate analyses.
 Although all
persons with BMI <18.5 kg/m2 were LF, LF trended toward higher relative
body fat content. LF subjects had a greater prevalence of sarcopenia
(50% vs 25%, p = 0.04), lower lean mass, and lower IGF-1/IGFBP3.

Conclusions:  Impaired functional capacity is strongly associated with
lower bone density and lower muscle mass in middle-aged HIV-1+ persons. 

Whether bone or muscle loss is the result of disuse due to impairment,
or if low muscle or bone mass, mediated through effects of IGF-1, leads
to impairment by progressive weakness or inflammatory pathways remains
to be established. Further studies should investigate the role of
increased muscle/bone mass and increased IGF-1 on preserving functional
independence as persons with HIV age.
————————–

Co-morbidity Is Predictive of Muscle Strength in HIV+ Veterans: Results
from the VACS Index

Krisann Oursler*1, J Tate2, T Gill2, K Crothers3, T Brown4, S Crystal5,
J Womack2, D Leaf6, J Sorkin1, A Justice2, and Veterans Aging Cohort
Study Project Team

1Univ of Maryland Sch of Med and Publ Hlth and VA Maryland Hlthcare
System, Baltimore, US; 2Yale Univ Sch of Med and Publ Hlth and VA
Connecticut Hlthcare System, New Haven, US; 3Univ of Washington,
Seattle, US; 4Johns Hopkins Univ, Baltimore, MD, US; 5Rutgers Univ, New
Brunswick, NJ, US; and 6Univ of California, Los Angeles Sch of Med and
Greater Los Angeles VA Hlthcare System, US

Background:  Despite improved survival, HIV+ adults have increased risk
for physical disability due to muscle weakness, poor ambulatory
function, and low cardiorespiratory fitness. The objective of this
study was to determine whether the VACS Index, a comprehensive index of
generalized organ injury based on routine clinical laboratory data, is
associated with hand-grip and leg-strength, 6-minute walk distance, and
cardiorespiratory fitness (peak oxygen consumption, VO2 peak).

Methods:  HIV+ patients enrolled in the Veterans Aging Cohort Study
(VACS) participated in this cross-sectional study at the Baltimore VA
Medical Center from 2004 to 2007. The VACS Index was calculated
incorporating hemoglobin, FIB-4, eGFR, hepatitis C infection, CD4
count, HIV-1 viral load, and age; higher score reflected greater
co-morbidity. Analyses included nonparametric correlation (Spearman’s
rank) and linear regression models.

Results:  We included 2 women and 53 men:  91% African American race,
mean age of 52 (SD 7) years. The VACS Index was inversely correlated
with hand-grip strength (r = –0.36, p = 0.01) and lower extremity
strength (quadriceps, r = –0.45, p <0.01), but was not significantly
associated with 6-minute walk distance (r = –0.26, p = 0.07) or VO2
peak (r = –0.13, p = 0.3). A 20-point higher VACS Index score was
associated with a 10% lower leg strength (mean 76 newtons; 95%CI –124
to –29; p <0.001; see the figure), which remained significant after
adjustment for muscle cross-sectional area (p = 0.04). The VACS Index
explained 34% of the variance in specific leg strength. In contrast, an
index restricted to CD4 count, viral load, and age did not correlate
with any of these measures (p >0.08).

Conclusions:  In this sample of predominantly African American men
ranging in age from 31 to 72 years, the VACS Index was significantly
associated with upper and lower extremity strength
. The VACS Index may
be valuable for identification of patients at high risk for disability
due to muscle weakness. Association of Leg Strength with the VACS Index.

Fw: Breaking, Clinically Relevant HIV/AIDS Research From CROI 2012

From: “The Body PRO” <news@thebodypro.com>
Date: 08 Mar 2012 14:38:17 -0500
To: <powertx@aol.com>
ReplyTo: “The Body PRO” <news@thebodypro.com>
Subject: Breaking, Clinically Relevant HIV/AIDS Research From CROI 2012

Welcome to The Body PRO Newsletter, a bi-weekly review of the latest breaking news and research in HIV medicine, aimed specifically at informing health care professionals.
TheBodyPRO.com covers CROI 2012
STUDY SUMMARIES AND ANALYSES FROM CROI 2012
The 19th Conference on Retroviruses and Opportunistic Infections (CROI 2012) is wrapping up in Seattle, Wash., but TheBodyPRO.com’s coverage of this critical meeting is just heating up!

Visit our CROI 2012 home page for a growing selection of articles in which our team recaps and analyzes the clinical significance of a wide array of presented studies. Currently available conference coverage includes:

Much more will be added over the next several days, including the latest on antiretroviral clinical trials, immune-based therapies and a range of HIV-related comorbidities. Be sure to check back often for the latest summaries, analyses and discussions on clinically relevant CROI 2012 research — and follow @MylesatTheBody on Twitter for bite-sized, real-time updates directly from the conference.
IN OTHER NEWS
Although CROI 2012 is capturing headlines on the research front this week, the world keeps on turning, and there are other developments to report that are of importance to HIV frontline professionals. Here is a sampling of stories recently published on TheBodyPRO.com:

  • New HIV Care Guidelines Focus on Entry Into and Retention in Care
    In this week’s Annals of Internal Medicine, an expert panel convened by the International Association of Physicians in AIDS Care (IAPAC) published guidelines on entry into care, patient retention and adherence to HIV medications. Ben Young, M.D., Ph.D., examines why we these new guidelines are worth paying attention to.
  • Interactions Between Protease Inhibitors and Statins Can Increase the Risk of Muscle Injury
    A new U.S. Food and Drug Administration warning cautions against drug-drug interactions between statins and protease inhibitors used in the treatment of HIV and hepatitis C. The warning states that the interaction can cause an increase in statin levels that may increase myopathy risk.
  • Tenofovir Linked With Risk of Kidney Damage
    A recent study offers the most conclusive evidence to date that tenofovir (Viread), one of the fundamental backbones of antiretroviral therapy in the U.S., can increase an HIV-infected patient’s risk of kidney damage and chronic renal disease. Despite the findings, the clinical ramifications of the data are unclear.
  • HIV/AIDS Organization Spotlight: Mujeres Unidas
    HIV stigma still runs deep in San Antonio, Texas, where many HIV-infected patients are Latinos. “We’ve got people in doctors’ offices — front offices, back offices — where we’ve had clients that appear for an appointment, and they’re told, ‘Oh, the doctors won’t see patients like you,'” says Tina Sigler, the executive director of Mujeres Unidas.
  • Mapping the Virus With Geographic Information Systems
    A new type of technology may allow frontline HIV professionals and public health officials across the U.S. to develop a more complete understanding for the drivers of HIV in their communities than ever before. It does so by tying basic info about the area (such as education, income levels or even the presence of mass transportation options) into HIV-specific data such as incidence and prevalence.


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Pre-CROI HIV Cure Review Workshop Organized by Community Advocates- Meeting Notes

Thanks to Siegfried Schwarze, a research activist from  Germany, for writing down these notes from the meeting we had this past Sunday, March 4, 2012 in Seattle prior to CROI-2012.
****************************************************************************
Sometimes the most important events don‘t take place at the conference
itself but rather at  the surrounding
workshops. This seemed to be the case this year. Before the official opening of
the Retrovirus Conference, American activists organized a cure workshop.
Among the 60 or so participants there were even some high-profile researchers
and FDA employees underlining the quality of this workshop.
Dan Kuritzkes started with an overview of the work of the Aids Clinical
Trials Group (ACTG)
in the field of the cure, this being meanwhile the focus
of the work of this study network. He emphasized the importance of asking the
right questions first:
–  Can the residual virus production below the limit of detection been
suppressed by intensification?
–  is there a practically relevant decay of latent reservoirs?
–  can strategies that activate latent cells further lower the viral load?
–  can a combined approach lead to control of viral replication without
drugs (functional cure)?
Apart from that, we must first find out how to approach the reservoirs
methodically and what to measure.
Then he gave an overview of current ACTG trials:
–  A5276s: Patients with ongoing viral replication inspite of therapy (70
patients recruited, further 40 patients identified as suitable)
–  Planned study to look at the decay of reservoirs in different patient
groups (acute / chronic infected, elite controller, blipper, patients failing
therapy / resuppressing)
Interventional studies:
–  A5248/9s: Viral dynamics with TDF/FTC/RAL (cf. Abstract 672). Since
viral decay is much faster with Raltegravir-containing regimens, the pecularities of
this combination should be looked at.
–  A5281: studying a multi-antigen/cytokine/DNA-vaccine (already
recruiting, so far no tolerability issues)
–  A5286: Study looking at Rifaximin (an oral broad-band antibiotic that
is not being resorbed and therefore active only in the gut). Can the microbial
translocation and the resulting systemic inflammation be mitigated? Also the
influence on the reservoirs is to be studied.
–  A52301: Anti-PD1-Antibody: Quiescent cells harboring latent HIV can be
forced out of latency with antibodies against the PD1-receptor and start
producing virus. This study is still in concept phase.
–  A52308: ART for elite controllers
–  PR652: Effect of romidepsin (a cancer drug developed by Celgene that
also acts as HDAC-inhibitor that can activate latent cells but isn‘t mutagenic
in the Ames test as other drugs of this class) on the reservoirs: concept
Finally, Kuritzkes came back to the questions that need to be addressed:
–  What is the goal?
–  sterilizing cure?
–  functional cure, i.e. control of the virus by the immune system?
–  reduction / elimination of the remaining viral load?
–  reduction / elimination of viral reservoirs in the various
compartments?
Which endpoints should be looked at?
–  proof of biological activity on the target or the selected mechanism?
–  proviral DNA in PBMSs?
–  proviral DNA in cells of the compartments (which?)?
–  cell-/tissue associated viral RNA?
–  no viremia during analytical treatment interruption (ATI)
Here he pointed out the (dis-)advantages of an ATI:
Pros:
-Best test for functional cure
-quantitative and qualitative analysis possible:
            -Rebound of viral load
(or lack of)          
–  time to rebound
–  time to new setpoint
–  setpoint at a new (lower) level than before therapy
Cons:
–  Risk of inflammatory syndrome like during primary infection
–  risk for OI, CV-events, death (like in SMART-study)
–  increased transmission risk
We also have to think which patients are best being studied:
–  patients with successful ART (i.e. undetectable VL)
–  first vs. following regimes?
–  highly therapy experienced patients?
–  patients with well preserved immune function (high CD4-counts) or with
advanced disease?
–  Elite controller?
–  acutely infected patients?
–  patients in need of a bone marrow transplant?
Finally, we must not forget the risk-benefit-balance since all new
therapies will have to compete with established ART which is generally well
tolerated and harbors usually only minor risks.
After that, Romas Geleziunas, Director of Virology at Gilead Sciences
gave an overview of his company‘s activities in this area.
Gilead is focussing on the activation of HIV-expression in latently
infected cells.
There are several possibilities:
–  De-repress chromatin (HDAC-inhibitors)
–  activate transcription factors (NF-ƘB)
–  activate HIV mRNA Elongation (PTEF-b)
–  Other mechanisms, still to be found by Hight-throughput analysis (HTS)
Gilead has developed an automatic system that can measure the reversal
of latency with high numbers of samples at the same time. Already several new
drugs have been discovered that can wake cells from latency. One of these,
GSI-002 has the advantage of not being mutagenic and not activating T-cells
itself. Some other compounds they found have such unbelievable names as “Thapsigargin“ or “Tyrphostin A“.
Another possible mechanism to eliminate HIV uses the “toll-like-receptor 7“ (TLR7). This receptor binds single-strand RNA and leads
to the production of type-1 interferons (IFN alpha/beta). GS-9620 is a
TLR7-agonist that has been shown to lower RNA and viral antigen production in
several animal models. In a next step they will look whether this drug can play
a role in eliminating HIV-infected cells. The mechanism of HIV latency needs to
be understood still more fully and new drugs need to be discovered that play a
role in or can interfere with this process.
Dale Ando, working for Sangamo Biosciences, once more presented the
method of his company to knock out the gene for the CCR5-receptor with sequence
specific zinc finger nucleases. This leads to CD4-cells that are immune against
infection with CCR5-tropic HIV. Unfortunately, they didn‘t show any new data.
The procedure seemed to have worked exceptionally well in one patient, who is
heterozygous for the Δ32-mutation, i.e. he has only one functional CCR5-gene
per cell. Therefore, the next studies will recruit preferentally such patients.
Furthermore, the procedure will be adapted for stem cells. The problem is, that
the introduction of the zinc finger nuclease into the cells also triggers the
differentiation process and the cells wouldn‘t be stem cells any more.
Sometimes the devil is lurking in the details… Good news is, that the
procedure has been automated, so more patients can be treated which facilitates
larger studies.
Birger Sørensen from Bionor Pharma, a small Norwegian Biotech company
with only 19 employees presented a very interesting approach: They changed
certain highly conservated regions of the p24 protein in a way that makes it
much more effectively recognized by human immune cells. For some time it was
already known that infected people with a strong immune response against p24
have a slower disease progression. In order to further strengthen the vaccine
response, they use their product called Vacc-4x together with GM-CSF (a growth
factor for granulocytes/macrophages). Four primary and booster immunizations in
40 patients led to 92% showing a immune response with good tolerability. In
another study patients were immunized while on ART, then there was a 10 week
waiting period to allow the immune system to calm down and finally ART was
stopped. In all patients the viral load rebounded upon interruption, but the
vaccinated patients reached a new setpoint that was about 0,4 log lower (i.e. average
viral load 20.000 cp/ml instead of 60.000). They hope to further lower the
setpoint with more round of vaccination. In addition they try to improve the
immune response with immune modulators like lenalidomide.
Another approach, called Vacc-C5 aims in a different direction:
antibodies against the C5-region of gp120 cannot neutralize the virus, but they
still lead to a slower disease progression. This is probably because the
complex of C5 and gp41 bears some similiarity with the human HLA-complex and can
hyperactivate the immune system. Antibodies can block this hyperactivation and
so slow down the disease progression. In animal trials it was possible to
produce antibodies with the Vacc-C5 vaccine. Trials in humans are planned. Both
approaches together would make use of the cellular as well as the humoral arm
of the immune system and such a combined approach could be an important step on
the way to a cure. The main problem right now is money because studies are
expensive and a small company like Bionor is heavily dependent on investors.
John Zaia from Beckmann Research Institute gave an overview over the
state of stem cell research in the area of HIV. It was a stem cell transplant
that led to the cure of the “Berlin patient” and brought cure research back on
the scientific agenda of the HIV researcher. But it is still unknown which
factors were important for this experiment to succeed. Some researchers think
that the graft-vs.-host-reaction, which almost killed the patient, was crucial
– in addition to the radiation and the intense chemotherapy. So far, there is
no second “Berlin patient”, probably because the combination of the right
tissue antigens and the CCR5-Mutation is rather rare. That‘s why they try to
introduce the required CCR5-mutation artifically in bone marrow cells of
donors. Another possibility to get stem cells is cord blod from newborns. But
again here is the problem of the rare occurence of a CCR5-Mutation so there are
plans to found a blood bank of cord blood with CCR5-Mutation. Alltogether the
field of stem cell therapy is still in it‘s infancy. In patients who don‘t need
a stem cell transplant for medical reasons (i.e. lymphoma), the risks are still
too high. This method has only a chance for broader use when there will be new
developments making radiation and chemotherapy unnecessary.
Pablo Tebas gave an overview over the activities of his workgroup.
Apart from collaboration with Sangamon in the field of zinc finger nuclease
(see above), the group also tries to increase the CD8-mediated killing of
HIV-infected cells by providing the CD8s with a new T-cell-receptor that can
recognize HIV much better than it‘s natural counterpart. Clinical studies
including 16 weeks of ATI and rectum biopsies are planned. And there is renewed
interest in the long known antiviral activity of interferon alpha against HIV.
In a study with HIV patients that had undetectable viral load, stopped therapy
and used pegylated interferon alpha as monotherapy, the viral load could be
kept below 400 cp/ml in 45%. At the same time, the number of integrated HIV
genomes in the circulating CD4-cells went down. Interestingly, this effect was
also seen in a group of patients receiving only half of the standard dose (90
µg instead of 180 µg interferon alpha per week) – with much better
tolerability.
David Evans and Nelson Vergel, two of the activists who had organized
the workshop, did a internet survey about the willingness of patients to
participate in clinical studies that are not of immediate benefit to them but
maybe even have some serious risks. They found among many other things, that
unexpectedly many patients would consider participating in such studies for
mainly altruistic reasons.
Steven Deeks provide additional insight in the mechanisms of viral
persistence of HIV:
–  reservoir of long living CD4 positive Tcm (Central Memory cells)
harboring transcriptionally inactive HIV genome (latently infected)
–  homeostatic proliferation of these cells (i.e. because these cells
divide to make up for natural decay, the integrated HIV genome will also be
distributed to the daughter cells and the number of latently infected cells
therefore decreases very slowly)
–  low level („cryptic“) viral replication induced by environmental
stimuli, e.g. interactions with HIV infected CD4-cells in tissue.
–  failure to develop or maintain an effective anti HIV immune response
Deeks described these mechanisms in further detail and also some ideas
how to overcome them, e.g. antibodies against PD1 to reverse latency.
Keith Jerome and Hans-Peter Kiem were the last presenter and described
their efforts to
–  establish an HIV-resistant immune system permanently in patients and to
–  eliminate existing HIV reservoirs.
For the first goal they also use zinc finger nucleases. The viral
reservoirs will be attacked with different tools: One idea is to mark infected
cells with siRNA-probes to make them visible for the immune system so that
killer cells can get rid off the infected cells. Another method uses “homing
endonucleases”, special restriction enzymes from yeast. The enzyme Y2-Anil has
been changed in a way to recognize HIV-specific areas in the genome and cut
them. These cuts will be recognized by the cells repair system and the gaps
will be filled with random nucleosides. This leads to “nonsense“ viral sequence
that doesn‘t produce active virus anymore. This method has a big advantage
against the Tre-recombinase that has been described some time ago. Y2-Anil
recognizes longer, very conserved regions of HIV so that it could be effective
against a broad range of different HIV types whereas Tre recombinase is limited
to the LTR region of HIV (in fact the efficacy of Tre recombinase has been
shown only against a very artificial laboratory strain of HIV and not the wild
type virus).
All speakers of this exceptional workshop shared the view that we must
not raise premature and unrealistic hopes in patients. First steps have been
made but we need many more successes in analytics, basic science and
translational research in the animal model as well as in patients before the cure
will be within reach.
Siegfried Schwarze

Report of This Weekend’s HIV Cure Workshop in Seattle

A couple of months ago a rag tag group of activist–including Project Inform (represented by myself), the Treatment Action Group (TAG) and the AIDS Treatment Activists Coalition (ATAC)–reached out to some of the world’s leading HIV researchers and companies working on HIV cure research and asked them to spend an entire day with us talking about potential barriers to moving such research forward at the fastest possible pace.
We also asked them to tell us the things that people like us–ordinary people with HIV and their allies–could do to boost research momentum and progress. At first, we were worried they might not be willing to add yet another day to an already long conference, the Conference on Retroviruses and Opportunistic Infections (CROI), taking place the following week. Would they see activists as worthy allies? Would they consider our goal–to map out an advocacy agenda to increase and hasten HIV cure research–something worth spending their time on?

Fw: Hot Topics at The Body’s “Ask the Experts” Forums

From: “News at The Body” <update@news.thebody.com>
Date: 06 Mar 2012 15:17:15 -0500
To: <nelsonvergel@yahoo.com>
ReplyTo: “News at The Body” <update@news.thebody.com>
Subject: Hot Topics at The Body’s “Ask the Experts” Forums

If you have trouble reading this e-mail, you can see the online version at: www.thebody.com/topics.html
March 6, 2012 Visit the Forums “Hot Topics” Library Change/Update Subscription

LIVING WITH HIV/AIDS

 Are You Giving Up on the Cure?
I was reading your last response about a functional HIV cure in which you claimed that it would most likely take more than 10 years to develop a cure. Reading your previous responses on the issue you seemed much more optimistic. What happened?

Nelson Vergel responds in the “Aging With HIV” forum

MIXED-STATUS COUPLES

 How Much of a Risk Are We Taking With Unprotected Oral Sex?
I’m an HIV-negative man and my girlfriend is HIV positive with a viral load of 200,000 and a CD4 count of 750. Oral sex is very important to both of us. I’ve performed unprotected oral sex on her multiple times, and vice versa, and we’re careful about sores and cuts; we always use condoms for intercourse. I’ve read literature that says anything from there’s no HIV risk with unprotected oral sex to I’m most likely already infected. What do you think? Do you know of any documented cases of someone contracting HIV from oral sex on a female?

Shannon R. Southall responds in the “Safe Sex and HIV Prevention” forum

INSURANCE, WORKPLACE & LEGAL CONCERNS

 How Can I Get Health Coverage Back for My Registered Domestic Partner?
I’m a retiree in California and have health coverage through my (former) employer, a large California-based aerospace company. My registered domestic partner has had health coverage for the past five years as my dependent. For 2012 my employer is denying coverage for domestic partners. Any idea why they can now refuse coverage, and what we can do about it?

Jacques Chambers, C.L.U., responds in the “Workplace and Insurance Issues” forum

 Two Chiropractors Refused to Treat Me: What Can I Do?
Two different chiropractors have refused to treat me due to my HIV status, directly stating that they didn’t have the proper gloves or facilities to treat “people like me.” Are there grounds to sue based on this type of discrimination? What actions can I take?

Christa Douaihy, Esq., responds in the “Legal Issues and HIV” forum

the latest in hiv research: croi 2012 @ thebody.com
Seattle What’s coming down the pipeline in HIV treatment, prevention and care? CROI is the largest annual science meeting in HIV, where researchers and clinicians go to learn the most important lessons and developments in the field. The gathering began this weekend, and TheBodyPRO.com — TheBody.com’s sister site for health professionals — will be on hand to bring you wide-ranging coverage.

Visit our CROI 2012 home page frequently this week for key study summaries and a discussion of conference highlights!

HIV/AIDS & HEPATITIS C TREATMENT

 What’s New With Ibalizumab?
I’ve had very good luck with ibalizumab, the drug in development (TNX-355, formerly known as Tanox). Can you give me an update on what’s going on with this drug in 2012? Are there any new developments we should know about?

Nelson Vergel responds in the “Nutrition and Exercise” forum

 Do Calcium and Magnesium Have a Negative Effect on Isentress?
I switched to a regimen of Isentress (raltegravir) and Truvada (tenofovir/FTC) recently and am doing very well on it so far. Every morning I usually drink a glass of milk after taking Isentress. I also take vitamin D and calcium supplements. I heard somewhere that calcium and magnesium can affect the effectiveness of Isentress. Is it true? Should I stop drinking milk when I take Isentress as well?

Benjamin Young, M.D., Ph.D., responds in the “Choosing Your Meds” forum

 Another Time Around With Hepatitis C Meds: For How Long Will I Be Treated?
I’m a 55-year-old man with hepatitis C genotype 1B (my initial viral load was 3.8 million) and in otherwise good health. I’m currently 20 weeks into triple therapy with Incivek (telaprevir), peginterferon and ribavirin, and my hepatitis C viral load was undetectable at four, eight and 12 weeks. I’ve been unsuccessful on dual therapy before. What does this mean for the length of my treatment course now?

Barbara McGovern, M.D., responds in the “Hepatitis and HIV Coinfection” forum

OTHER HEALTH ISSUES & HIV/AIDS

 Positive Anal Pap Smear but Negative HRA: What’s Going On?
I’ve been HIV positive for four years, with a CD4 count of 330 and an undetectable viral load for the past three and a half years. Recently I had a high-resolution anoscopy (HRA) and the examination didn’t show any abnormalities, so I was relieved at that. However, my anal Pap smear result showed anal intraepithelial neoplasia (AIN 2). Should I be worried about precancerous changes in my anal canal? How do you interpret these results? If I have HPV (human papillomavirus), how long would it take an HIV-positive person like me to get rid of it?

Nelson Vergel responds in the “Aging With HIV” forum

 How Do I Know if I’m Depressed?
I take Isentress (raltegravir), Selzentry (maraviroc, Celsentri) and Viramune (nevirapine). I’ve been HIV positive for 22 years and I’m doing well. However, lately I’ve been losing my drive to exercise and eat well, as I have for the past several decades. I still go dancing every weekend and have a great group of friends, but being single and keeping healthy just for myself is getting hard at age 63. Is this the state of mind the younger generation calls depression? Could it be a side effect of HIV meds? Do you think I’d take better care of myself if I were in a relationship?

David Fawcett, Ph.D., L.C.S.W., responds in the “Mental Health and HIV” forum

Connect With Others Pen Pal for a Poz Friend in Prison?
(A recent post from the “Living With HIV” board)

A friend of mine is HIV positive and has been in prison for the past 27 years for a crime he didn’t commit. Recently the Innocence Project has taken his case and they have hopes of having my friend released. He became HIV positive while being held in protective custody in 1985. I am hoping to connect him with someone who would like to be a pen pal / friend to him and answer some of his questions about living with HIV. Would anyone out there be interested in contacting him? — DawnW

Click here to join this discussion, or to start your own!

To do this, you’ll need to register with TheBody.com’s bulletin boards if you’re a new user. Registration is quick and anonymous (all you need is an e-mail address) — click here to get started!


HIV & HEPATITIS TRANSMISSION

 Can a Person With Hepatitis C Donate Organs?
Could someone living with hepatitis C (hep C) donate their organs (besides their liver) to others in general? Could they give organs to other people living with hep C?

Benjamin Young, M.D., Ph.D., responds in the “Choosing Your Meds” forum

 Why Was I Tested for HIV?
I just officially found out I’m pregnant. I already took a preliminary, preconception HIV test six months ago and it came back negative, but I was sent out for another test today. Why would they do this, since my husband and I are completely monogamous with each other and have participated in no other risky behavior since my last test? Is it possible that the first test was a false negative or was not done correctly? Do I need to be concerned?

Shannon R. Southall responds in the “Safe Sex and HIV Prevention” forum


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Activist Central

 Tell Gilead to Reduce the Cost of HIV Medications Now!

 Under Attack: Your Health Care Rights

 Ohioans Living With HIV/AIDS Need Our Help!

 Activists Launch New Survey to Help Speed HIV Cure Research

 Demand Hershey Reverse Decision on HIV+ Student and Dismiss School Officials

 Count HIV+ Women In! PWN Launches National Campaign on World AIDS Day

HIV Reservoirs and Cure Research Lecture at CROI 2012

The first presentation in this link shows Dr John Mellors speaking at the Conference of Retroviruses and Opportunistic Infections in Seattle on March  5, 2012.  He did a great job at an overview of where we are in HIV Cure Research.

HIV Reservoirs and Cure Research Lecture

ViiV Announces Expanded Access of New Integrase Inhibitor…But Activists Are Concerned About Its Potential Misuse

The dolutegravir expanded access program (EAP) has been designed to provide free access to Shionogi-ViiV Healthcare’s investigational integrase inhibitor, dolutegravir (DTG, S/GSK1349572) in an open-label protocol program to adults living with HIV who have documented raltegravir or elvitegravir resistance, who have limited treatment options, and who require DTG to construct a viable antiretroviral regimen for therapy. The dose is 50 mg twice a day for patients with multi drug resistance (the drug will also be eventually approved for once daily use for treatment naive patients)

But before you consider the use of this new drug, read the following warning: Activists Advise Caution About Access Program

Who can participate in the dolutegravir EAP (ING114916)?

The dolutegravir EAP is available to adults living with HIV who (Note: Not all inclusion criteria are listed):
  • Are male or female age 18 years or older (female patients of child-bearing potential should use every precaution to prevent pregnancy)
  • Have documented plasma HIV-1 RNA levels ≥400 copies/mL within 3 months prior to the screening visit
  • Have documented raltegravir or elvitegravir resistance
  • Are unable to construct a viable background regimen of anti-retroviral therapy with commercially available medications.
The dolutegravir EAP is not available to adults living with HIV who (Note: Not all exclusion criteria are listed):
  • Have estimated creatinine clearance (CrCl) <30 mL/min
  • Are pregnant or breastfeeding
  • Have had a known or suspected allergic reaction to an integrase inhibitor
  • Have an alanine aminotransferase (ALT) level >5 times the upper limit of normal (ULN)
  • Have an ALT >3 times ULN and total bilirubin >1.5 times ULN
  • Have evidence of severe hepatic impairment
  • Are eligible for, and have access to, an actively enrolling DTG Phase III clinical trial
  • Have any condition (including but not limited to alcohol and drug use) or any active clinically significant disease or findings during screening of medical history or physical examination, which, in the opinion of the treating physician would interfere with safety or compliance
  • Requires or is anticipated to require any of the prohibited concomitant therapy.
*Please note: country specific criteria may also apply.
The dolutegravir EAP is now open and accepting participants in the USA and Canada.
For Europe and the International region, it’s expected that the EAP will start to open in March/April 2012 as local regulatory and ethics approvals are obtained.

How to apply for participation

For adults living with HIV: Please discuss your possible participation with your healthcare professional. If the EAP is available in your country, check with your healthcare provider if he or she is a participating site. If not, your healthcare provider may contact PAREXEL for further details on how to access the program.
For healthcare professionals treating HIV: If you have an eligible patient(s), please contact PAREXEL at dolutegravir-eap@parexel.com for further details about the program.

What is dolutegravir?

Dolutegravir (DTG, GSK1349572) is an integrase inhibitor under development as a treatment for HIV-1 infection. Phase III studies to assess the safety and efficacy of dolutegravir in antiretroviral naïve and experienced adults living with HIV are currently underway. The safety and efficacy of dolutegravir has not yet been fully established or thoroughly evaluated by regulatory agencies.