HIV Lipoatrophy 2007

© Visionary Health Concepts, New York 2007

Released October 5, 2007

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The What, the Why, and the Howof Lipoatrophy in HIV CEU Information

Accreditation Statement(s): ANCCMedical Education Collaborative (MEC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

RNs, LPNs, LVNs and NPs can receive up to .7 contact hours for participation in this program. This program is cosponsored with Medical Education Collaborative, Inc. (MEC) and Visionary Health Concepts. Provider approved by the California Board of Registered Nursing, Provider Number CEP 12990, for .8 contact hour(s).

Joint SponsorThis activity is joint sponsored by Visionary Health Concepts and Medical Education Collaborative (MEC). MEC is a non-profit organization that has been certifying quality educational activities since 1988.

Commercial SupportThis activity was made possible by an educational grant from Abbott Laboratories.

Learning Objectives Upon completion of this educational activity, participants should be able to:

• Recognize the physical symptoms of HIV-associated lipoatrophy

• Assist patients in understanding the way lipoatrophy is diagnosed and treated

• Discuss recent studies related to ART and lipoatrophy

Target AudienceThis program is intended for all healthcare providers, including nurses, treating HIV-positive patients, especially those who are seeking current and comprehensive information on lipoatrophy.


Purpose StatementThe purpose of this program is to increase and improve patient/provider communication on the topic of lipoatrophy by providing both a simple, yet comprehensive, overview of the topic and an update of recent data related to the topic.

Release & Expiration DatesRelease date: October 5, 2007; Expiration date: October 5, 2008

Instructions for CreditThere are no fees for participating in or receiving credit for this educational activity. This activity was developed to be completed within the time designated on the title page; providers should claim only those credits that reflect the time actually spent in the activity. For questions regarding the accreditation of this activity, please contact Medical Education Collaborative at 303-420-3252.

Follow these steps to earn CEU:• Read the target audience, learning objectives, and faculty disclosures. • Study the educational content online or printed out. • Online, choose the best answer to each test question. • You many also print out and return the completed test to toll-free fax 800-407-2505. • To receive a certificate, participants must score at least a 70% on the post test and submit it along with the credit application and evaluation form to the address/fax number indicated. Statements of credit will be mailed within 6-8 weeks following the program.

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Faculty DisclosuresThe planning committee and faculty members have the following disclosures:

CEU ChairpersonAndrew Carr, MBBS, MD, FRACP, FRCPA

St. Vincent's Hospital; Professor of Medicine, University of New South Wales, Sydney, Australia

Dr. Andrew Carr has the following relationships to disclose: grants for paid research, speaker’s bureau and advisory boards from Abbott Laboratories.

EditorMaggie Sosa, APRN, BC, AACRN, ACHPNNPNurse Practitioner, Broadway House for Continuing Care, Newark, NJ, USA

Maggie Sosa has no relationships to disclose.


Faculty Disclosures continued

WritersLillian ThiemannPresident, Visionary Health Concepts, Gardiner, NY, USA Lillian Thiemann has no relationships to disclose. Deneen RobinsonSavant Consultants, Dallas TX, USA

Deneen Robinson has the following relationships to disclose: stock ownership: Abbott Laboratories; advisory committee: Bristol-Myers Squibb; speaker’s bureau: Gilead Sciences.

Accredited ProviderThe employees of Medical Education Collaborative, the accredited provider for this activity, have no significant relationships to disclose.


In The What, The Why, and The Howof Lipoatrophy in HIV slide set, we’ll:

• Describe what lipoatrophy is, and what it’s not

• Discuss current studies about lipoatrophy in HIV

• Provide information on surgical and non-surgical treatment of lipoatrophy

We’ll also:

• Explore the myths (and realities) of fat loss

• Provide tips for better communication with patients

• Point out the differences between lipoatrophy and AIDS wasting

• Review types of body fat changes (lipodystrophy)

Antiretroviral therapy extends life

Percentage of persons surviving through June 2005, by years after acquired immunodeficiency syndrome (AIDS) diagnosis cohorts during 1981-2003 and by year of diagnosis--United States

[Centers for Disease Control and Prevention 2005]

WWW.FREEHIV.COM DRUG CHARTCurrently-approved HIV medications

Easy-to-print version available at www.freehivinfo.com

NRTI, NtRTI - Nucleoside and or Nucleotide Reverse Transcriptase Inhibitors (nukes)

Brand name (generic name, abbreviation)

Picture Year approved

Retrovir®

(zidovudine, AZT)

1987

Videx® (didanosine; ddI):buffered versions

1991

Zerit® (stavudine; d4T) 1994

Epivir® (lamivudine; 3TC) 1995

Combivir® (Retrovir + Epivir, CBV) 1997

Ziagen® (abacavir, ABC) 1998

Trizivir® (Retrovir + Epivir + Ziagen)

2000

Videx® EC (didanosine; ddI): delayed-release capsules

2000

Viread® (tenofovir DF, TDF) 2001

Emtriva® (emtricitabine, FTC) 2003

NNRTI - Nonnucleoside Reverse Transcriptase Inhibitors (non-nukes)



Viramune® (nevirapine, NVP) 1996

Rescriptor® (delavirdine, DLV)

1997

Sustiva® (efavirenz, EFV) 1998

Atripla™ (Sustiva* + Viread + Emtriva),

* Viread and Emtirvia are non-nucleoside reverse transcriptase inhibitors (NRTIs).

2006

Crixivan® (indinavir, IDV) 1996

Norvir® (ritonavir, RTV) 1996

Viracept® (nelfinavir, NFV) 1997

Kaletra® (lopinavir + ritonavir, LPV/RTV)

2000

Lexiva® (fosamprenavir, fos-APV) 2003

Reyataz® (atazanavir, ATV) 2003

Aptivus® (tipranavir, TPV) 2005

Prezista™ (darunavir) 2006

Epzicom® (Ziagen + Epivir) 2004

Truvada® (Viread + Emtriva) 2004

Atripla™ (Sustiva* + Viread + Emtriva)* Sustiva is a non-nucleoside reverse transcriptase inhibitor (NNRTI)

2006

PI - Protease Inhibitors



Invirase® (saquinavir, SQV) 1995

Entry Inhibitors (including Fusion Inhibitors and CCR5 Antagonists)



Fuzeon® (enfuvirtide, T-20) 2003

Selzentry® (maraviroc) 2007

Lipodystrophy (lipo-diss-troh-fee)

• Lipo means fat, and the word dystrophy means abnormal looking

• A general “umbrella” term that is used to describe various changes that occur in the body in how it uses and distributes FAT

• The conditions that fall under the lipodystrophy umbrella can be very different in cause and effect

Lipodystrophy umbrella

Lipoatrophy (lip-oh-aah-troh-fee)

• Lipo means fat and atrophy means shrinkage

lipoatrophy = “fat loss”• Is often seen in people living with HIV who take

anti-HIV drugs

• Also can occur in those with HIV who have never taken anti-HIV drugs, and in other diseases such as diabetes or in rare genetic diseases

AIDS wasting is not lipoatrophy

Fat loss

Weight loss & diarrhea

CD4 Count

HIV under control?

Associated with risk of death?

Affects looks?

AIDS Wasting

yes yes Less than 50

No yes yes

Lipoatrophy(fat loss)

yes no Over 200 yes no yes

Lipoatrophy occurs in fat under the skin

• Face• Arms• Legs• Buttocks

Lipoatrophy occurs gradually

At first:• Legs, arms and face appear thinner• People may like that their cheekbones are starting to stand

out a little and that their body looks a little more “cut”

Then, as fat loss continues: • Skin loosens, becomes thinner • Bones, veins, tendons and muscles become much easier to see

Examples of lipoatrophy (men)

Examples of lipoatrophy (women)

FRAM Study Group

[FRAM Study Group. J Acquir Immune Defic Syndr. 2005;40:121-131.][FRAM Study Group. J Acquir Immune Defic Syndr. 2006;42:562-571.]

100

80

60

40

20

0

Per

iph

eral

Lip

oat

rop

hy

(%)

Belly fat gain Belly fat loss

NoYes

Belly fat loss

Men (n=425)

Women (n=183) 100

80

60

40

20

0

Per

iph

eral

Lip

oat

rop

hy

(%)

Belly fat gain

How many people have lipo?

• Reports vary from as little as 8% to 84%

– Largest studies suggest 40% to 65%

– The estimates are affected by how long people have been on HIV treatment and what type of HIV medication

• Reported less often in women—10% to 35%, and may be low due to underreporting.

[Bernasconi E et al. JAIDS 2002;31:50.] [Young J et al. Antiviral Therapy 2005;10:73.] [Miller J et al. HIV Med 2003;4:293.] [Lichtenstein KA et al. 13th CROI 2006; Denver. Abstract #769.] [Chen D et al. J Clin Enocrinol Metabol 2002;87:4845.]

Cause of lipoatrophy

• Anti-HIV medications are associated with fat loss

• Some anti-HIV medications cause more fat loss than others

[Lichtenstein KA. J Acquir Immune Defic Syndr. 2005; 39:395-400.][Jacobson DL, et al. Clinical Infectious Diseases 40(12):1837-1845. June 15, 2005.][Parker RA, etal. 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, 2005, Dublin, Ireland. Abs 4.. Antiviral Therapy 2005; 10:L5]

Families of HIV drugs: Nucleoside reverse transcriptase inhibitors (NRTIs)

Brand name Generic name Image

Atripla™ (Sustiva* + Viread + Emtriva)

efavirienz + tenofovir + emtricitabine

Combivir®

(Retrovir + Epivir)

zidovudine + lamivudine

Emtriva® emtricitabine, FTC

Epivir® lamivudine; 3TC

Retrovir® zidovudine, AZT

Trizivir® (Retrovir, Epivir + Ziagen)

zidovudine + lamivudine + abacavir


Truvada® (Viread + Emtriva

tenofovir + emtricitabine

Videx® didanosine; ddI

Videx® EC didanosine; ddI

Viread® tenofovir DF, TDF

Zerit® stavudine; d4T

Ziagen® abacavir, ABC

What are mitochondria?

• Mitochondria are the cell’s ‘energy factories’ where sugar and fat are burned to turn it into energy

• If mitochondria are damaged, fat cells start to shrink and then die

Switching anti-HIV drugs

Cha

nge

from

bas

elin

e (k

g)

Week

Switching NRTIs d4T/AZT did help reverse the fat loss.

However, there was no return to “normal”.

[Carr et al, AIDS 2001][Martin et al, AIDS 2004][McComsey et al, Clin Infect Dis 2004] [Milinkovic et al, CROI 2005]

[Carr et al, JAMA 2002][Moyle et al, CROI 2005] [Murphy et al, CROI 2005]

0

0.2

0.4

0.6

0.8

1

1.2

1.4

0 24 48 72 108

MITOX - ABCRAVE - ABCRAVE - TDFTARHEELtNRTI to rLPVd4T4030 - TDF

Families of HIV drugs: Non nucleoside reverse transcriptase inhibitors (NRTIS)


Atripla™ (Sustiva* + Viread + Emtriva)

efavirienz + tenofovir + emtricitabine

Rescriptor® delavirdine, DLV

Sustiva® efavirenz, EFV

Viramune® nevirapine, NVP

ACTG 5142

ACTG 5142: A study that compared three anti-HIV drug combos– NNRTI + 2 NRTIs [Sustiva (efavirenz) + 2 NRTIs]– Protease inhibitor + 2 NRTIs [Kaletra (lopinavir/rt)+ 2 NRTIs]– NNRTI + PI [Sustiva + Kaletra (no NRTIs)]

Results:– Sustiva + NRTIs is two times more likely to cause fat loss

(lipoatrophy) than Kaletra + NRTIs– Sustiva + Kaletra had lowest rate of fat loss

• 8% at 96 weeks compared to 36% in Sustiva + NRTIs arm vs 18% in Kaletra + NRTIs arm

– Patients using Viread (tenofovir, TDF) had less fat loss compared to other NRTIs used—Retrovir (AZT) or Zerit (d4T)

[Haubrich R, Riddler S, DiRienzo G, et al. 14th CROI, Los Angeles, 2007, Abs 38.]

[Riddler SA, Haubrich R, DiRienzo G, et al. XVI International AIDS Conference, Toronto, 2006, Abs THLB0204.]

Families of HIV drugs:Protease Inhibitors (PIs)


Aptivus® tipranavir, TPV

Crixivan® indinavir, IDV

Invirase® saquinavir, SQV

Kaletra® lopinavir + ritonavir, LPV/RTV

Lexiva® fosamprenavir, fos-APV


Norvir® ritonavir, RTV

Prezista™ darunavir, DRV

Reyataz® atazanavir, ATV

Viracept® nelfinavir, NFV

Families of HIV drugs:Entry Inhibitors


Fuzeon® enfuvirtide, ENF

Selzentry® maraviroc, MRV

Summary of factors

Factors not associated with lipoatrophy:

• Diabetes

• Lower nadir CD4+ cell counts

• White race

Ass

Factors associated with lipoatrophy:

• Specific NRTIs (Zerit and Videx)

• Lower baseline CD4, body mass index (BMI),

• Cholesterol treatment

[Lichtenstein KA. J Acquir Immune Defic Syndr. 2005; 39:395-400;] [Moyle, G. et al. The Rave Study. ICAAC, 2005]

SMART Study

People experiencing fat loss ask, “SHOULD I STOP MY PILLS?”

The short answer is: “NO!”

The long answer includes information about the SMART Study:• A huge study (5,472 people), SMART compared continuous anti-HIV

treatment against intermittent (“on and off”) treatment to see if side effects could be lessened and the virus still controlled or suppressed

• The study was stopped because of more AIDS and more deaths in the intermittent group; risk of heart disease was also greater in this group

[Phillips A, Carr A, Neuhaus J, et al. CROI 2007 Abs 41. ]

Take-home messages

• Daily, continuous anti-HIV treatment is better for the heart AND for controlling HIV than “on and off” anti-HIV treatment

• Some anti-HIV drugs cause less fat loss than others

• It’s better to avoid fat loss than to try to get fat back once it’s gone

Detecting fat loss

Facial lipoatrophy grading

Progression of facial fat loss

–Grade 1: Obvious only to patient

–Grade 2: Others start to notice

–Grade 3: Everyone notices

–Grade 4: Mirrors become the enemy

[Grinspoon, Carr. N Engl J Med 2005; 352:48.][James J et al. Dermatol Surg 2002;11:979–986.]

Self-reported fat loss

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

UpperBack

AbdominalFat

WaistChestNeckLegsButtocksArmsFaceCheeks0

Men

Women

HIV+ HIV-

% R

ep

ort

ing

Fa

t L

os

s%

Re

po

rtin

g F

at

Lo

ss

[FRAM Study Group. J Acquir Immune Defic Syndr. 2005;40:121-131.][FRAM Study Group. J Acquir Immune Defic Syndr. 2006;42:562-571.]

Tools to measure fat loss

• Different amounts x-ray energy are absorbed by fat, muscle and bone

• Exposes patient to only 20% of the radiation that a regular chest x-ray uses

• Very accurate; recommended at change of HIV therapy, especially when fat loss is reason for switch

• Covered by most insurance

DEXA (Dual-Energy X-ray Absorptiometry)

[Levine J et al. [Levine J et al. J Appl PhysiolJ Appl Physiol 2000;88:452.] 2000;88:452.]

[Kamel E. et al [Kamel E. et al Obes ResObes Res 2000;8:36.] 2000;8:36.]

[Mitsiopouools [Mitsiopouools J Appl PhysiolJ Appl Physiol 1998;85:115.] 1998;85:115.]

Tools to measure fat loss (2)

• Uses x-rays to look at slices of the body. Expensive, more commonly used to measure fat gain, exposes patient to radiation, 1 per year allowed.

Lower jaw (mandible) measure - left

[Carey D et al. CROI 2007; Los Angeles. Abs #40.]

CAT scan

•Baseline mandible - left•Baselines drawn between points of bone •Maximum distance to skin line measured


Skin-fold test A metal tool is used to “pinch” body tissue in several places. The measurements are compared to standards. Requires a skilled technician.

MRI (Magnetic Resonance Imaging) uses a magnetic field to create an image of the body showing the location and amount of fat; very expensive

[Levine J et al. [Levine J et al. J Appl PhysiolJ Appl Physiol 2000;88:452.] 2000;88:452.][Kamel E. et al [Kamel E. et al Obes ResObes Res 2000;8:36.] 2000;8:36.] [Mitsiopouools [Mitsiopouools J Appl PhysiolJ Appl Physiol 1998;85:115.] 1998;85:115.]


Waist-to-hip ratio uses a mathematical formula to measure fat:

• May not hold true for people with HIV who have gained fat around the waist

• Gender and how much a person is overweight has

to be brought into the equation

Take-home messages

DEXA is the best test to get an all-around look at fat loss:

• Reliable and fairly easy to get for most people in the US

• Can measure facial fat loss

• Also measures bone density

So why does fat loss matter?

Fat loss and stigma

Fat loss may:• Be an unintentional signal to others of HIV-positive status• Decrease a person’s confidence and social involvement • Cause a person to avoid or stop needed anti-HIV medication

because of fear of stigma

[O’Donovan CA, et al.. 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. November 13-16, 2005, Dublin, Ireland. Abs 34. Antiviral Therapy 2005; 10:L24.]

HIV-related stigma

The general public still fears and judges people living with HIV, and such feelings can:• Cause negative feelings toward persons living with HIV/AIDS, their

families and friends

• Make it easy to justify treating those of different gender, sexuality, and race badly

[Rintamaki L, Davis T, et al. AIDS Patient Care and STDs. 2006, 20(5): 359-368. doi:10.1089/apc.2006.20.359.]

Management options

1. Non-surgical options

2. Surgical options

Two main types of management options have been studied in clinical trials:

The goal is to look normal

Can’t we just take another pill?

Agents studied to try to increase fat

Results

Rosiglitazone Minimal effect and may hurt heart by raising cholesterol and triglycerides

Pioglitazone In one study pioglitazone raised limb fat but only in those NOT taking Zerit (stavudine, d4T)

Pravastatin Fat gains shown but the study was small, and of short (12W) duration

Uridine NucleoMaxx® is EXPENSIVE! Fat gains shown but the study was small, and of short (12W) duration

Human Growth Hormone Makes fat loss worse

[Slam L, et al. 13th CROI 151LB.] [Cavalcanti RB, et al. and Grinspoon S et al. J Infect Dis.--both Published online, ahead of print (May 2, 2007).] [Mallon PWG et al. Antiviral Therapy 10: L5, 2005.] [Macallan, DC, et al.. 46th ICAAC. Abs H-1897.]

]

Surgical options - facial restoration

• There are currently several treatments to restore the appearance of the face

• These products are facial fillers that correct the symptoms of lipoatrophy

• They do not correct the cause of the problem: fat cell destruction

Commonly-used options for HIV-related facial lipoatrophyPRODUCT TYPE/SESSIONS FDA APPROVED? COST

Sculptra (Poly-L-lactic acid)

Non-permanent/

several sessions needed

Yes Patient assistance for product only (under $40,000/yr income: www.needymeds.com/papforms/ sculpt1039.pdf). Labor cost avg. $400 per session. Full price: $1100 per session for product.

Radiesse (Calcium hydroxylapatite)

Non-permanent/


Yes Patient assistance for product only (under $80,000 a year w/sliding scale). Labor avg. $400 Full price: $1200 per session.

Silikon 1000 (Purified polydimethyls-iloxane)

Permanent/


Off label use: FDA approved for intraocular injections to treat CMV- related retinal detachment

No patient assistance available. Full price: $800 per session.

Table provided by PoWeR (Program for Wellness Restoration) and www.facialwasting.org. Source: Comparison of Poly-L-lactic Acid and Calcium Hydroxylapatite for Treating Human Immunodeficiency Virus-Associated Facial Lipoatrophy; Cosmetic Dermatology, May 2007, Vol 20 No. 5

Commonly used options for HIV-related facial lipoatrophy (2)

PRODUCT TYPE/SESSIONS APPROVED? COST

PMMA-polymethylmethacrylate

Permanent/

1-2 sessions needed

Not FDA approved: Mexico, Brazil

$1200 avg total cost

Autologous fat transfer: fat pulled from one spot in the body and injected into the face

Non-permanent/


FDA approved $3,000 avg total cost

Hyaluronic Acid (Restylane, Perlane, Hylaform)

Permanent/ several sessions needed

Only Restylane is FDA approved

Approximately $1,500 per visit

Polyalkylimide (Bioalcamid)

Permanent/ several sessions needed

Not FDA approved: Europe, Canada, Mexico, others

$4,500 avg total

Table provided by PoWeR (Program for Wellness Restoration) and www.facialwasting.org. Source: Comparison of Poly-L-lactic Acid and Calcium Hydroxylapatite for Treating Human Immunodeficiency Virus-Associated Facial Lipoatrophy; Cosmetic Dermatology, May 2007, Vol 20 No. 5

Before After

• The hope is that the results will be visible and safe

• There is risk of infection and unwanted results with all facial fillers

Reconstructive therapy recommendations: DHHS 2006

Adverse effects Fat maldistribution

Causative ARVs PIs; d4T

Onset /clinical manifestations

Onset: Gradual: months after initiation of therapy

Symptoms:

• Lipoatrophy: peripheral fat loss manifested as facial thinning, thinning or extremities and buttocks (d4T)

• Increase in abdominal girth, breast size, and dorsocervical fat pad (buffalo hump)

Estimated frequency High: exact frequency uncertain; increases with duration on offending agent

Risk factors Lipoatrophy: low baseline body mass index

Prevention/Monitoring None to date

Management • Switching to other agents may slow or halt progression; however, may not reverse effects

• Injectable poly-L-lactic acid for treatment of facial lipoatrophy

[DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents 2006]

Butt-enhancer pants

• Padded shorts are designed to

– Make sitting less painful

– Fill out clothing and give a more “normal” rear view

Butt pants add back

• Male and female versions available• Cost $35-$40

What have we learned?

• It is better to avoid fat loss in the first place with careful anti-HIV drug selection than to try to fix it after it’s gone: The NRTI, Zerit (stavudine, d4T)—and to a lesser extent, Retrovir (zidovudine, AZT)—are to be avoided, if possible.

• Some anti-HIV drugs are more fat-loss friendly than others: Viread (tenofovir), Ziagen (abacavir), Kaletra (lopinavir/ritonavir) have all shown little—or significantly less—fat loss than the drugs they were compared to in recent studies

• Switching Zerit or Retrovir to fat-loss friendly NRTIs can help restore some fat, but a return to “normal” isn’t happening

• Use DEXA scan to assess for fat loss (or fat gain) early on and later in therapy. It’s good to have results from different time periods to compare

• There are patient assistance programs available to help with cost of two facial filler treatments

Tips to assist patients

• Always ask healthcare providers to do his/her homework (you do some too!) before choosing various therapies

• Be sure to continue to find ways to obtain up-to-date information and resources related to fat loss, and share the info with others

Patient–provider communication

• Taking anti-HIV therapy when and how it is supposed to be taken is a key part of HIV treatment success

• Healthcare providers should address all stigma-related issues (including fat loss) when counseling patients before antiretroviral treatment is started

Patient–provider communication (2)

• Counsel patients about when to start or change anti-HIV treatments

• Listen to patients’ concerns and assist them in finding the anti-HIV medicines that best fit their needs

[Rintamaki L, Davis T, et al. AIDS PATIENT CARE and STDs, Volume 20, Number 5, 2006]

Resources

For more lipoatrophy and HIV–related info: • Search term for Internet: HIV lipoatrophy 2007 • www.thebody.com• www.aidsmeds.com• www.thewellproject.com • www.aids-etc.org

For more info on padded undershorts:

• www.buttforyou.com

• www.lipowear.com

For providers: Lipodystrophy Case Definition webtools

• www.ti3m.com/hiv/default_ld.htm

Resources (2)

For more info on facial fillers:

• www.facialwasting.org

• www.sculptra.com

• www.thebody.com/lipo/sculptura

• www.jromano.com

The What, the Why, and the Howof Lipoatrophy in HIV

Legal DisclaimerThe material presented here does not necessarily reflect the views of

Visionary Health Concepts or companies that support educational programming on www.freehivinfo.com. These materials may discuss

therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare

professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

Copyright© 2007 Visionary Health Concepts

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