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Is It “Harm Reduction” or “First Do No Harm” ?

Is It “Harm Reduction” or “First Do No Harm” ?. James M Sosman, MD Section of General Internal medicine University of Wisconsin School of Medicine and Public Health. Case. ID: AK is a 52 yo man who presents CC: routine 6 month follow up for HIV

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Is It “Harm Reduction” or “First Do No Harm” ?

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  1. Is It “Harm Reduction” or “First Do No Harm” ? James M Sosman, MD Section of General Internal medicine University of Wisconsin School of Medicine and Public Health

  2. Case • ID: AK is a 52 yo man who presents • CC: routine 6 month follow up for HIV • HPI: AK was diagnosed HIV+ 5/05 during routine STD/HIV screening. He has been Asx. He reports that he would like to start a relationship with a HIV+ man who is on ART. AK has been reading and talking to others and learned that if he starts ART his risk of transmitting HIV may be “zero”. He inquires about the possibility of starting ART to reduce this risk, preferably with the new single pill ART.

  3. Case • PMHx: • No history of STD or genital warts • No medical problems • Hx of abdomenal liposuction • NKAD • Medications: none

  4. Case • SHx: • Worked as administrator • Lives alone, occasional ETOH no IDU no illicit drug use • Divorced and considers himself homosexual • Multiple prior sexual partners. He mostly used condoms but not with his previous main partner. • ROS: denies urethral, anal or oral discharge, pain or trauma/bleeding

  5. Case • PE: AK is in NAD and looks younger than stated age. • VS: 115/70, 70, 18, wt 170lbs • Remainder of exam WNL

  6. Case

  7. Case • Should we start AK on antiretroviral medication for the reasons he stated-to reduce the risk of HIV transmission?

  8. Dramatic Declines in AIDS Mortality Rates: 1996-2001 Mortality vs. ART utilization 100 40 Percentage of Patient-days on HAART 35 USE OF ART 30 75 25 DEATHS Percentage of patient-days on ART 20 50 Deaths per 100 person-years 15 10 25 Deaths per 100 Person-Years 5 0 0 1995 1996 1997 1998 1999 2000 2001 Palella F et al. 8th CROI 2001; abstract 268b.

  9. IMMUNE RECONSTITUTION 1000 >750,000 750 Viral Load (Copies/cc) 500 100,000 CD4 Counts (cells/cubic ml) 250 Detectable 0 0 1 2 3 4 5 12 24 48 Increased Risk OI Decreased Risk OI Time (Weeks)

  10. CD4 Cell Counts Increase through 7 Years of HAART Regardless of Baseline CD4 Cell Count Mean absolute value at year 7 = 776 cells/mm3 +501 cells/mm3 (n=60) Week Murphy R. et al., 10th EACS, Dublin, Ireland, November 2005, #P7.9/3 Study 720

  11. A Common Choice in Initial Once Daily HIV Treatment Tenofovir+FTC Efavirenz Plus Or Or One of several daily ritonavirboosted protease inhibitors: Atazanavir/rtv, Fos-amprenavir/rtv, Kaletra LPV/rtv Abacavir+3TC

  12. When to Initiate Treatment? • “Decision to begin therapy in the asymptomatic patient ... is complex” • Immune reconstitution impressive when starting at a CD4 > 200 cells/mm3 • Consensus that this is lower limit • CD4 <200 cells/mm3 is associated with opportunistic infections, disease progression, and mortality • Adherence fatigue • Risk of resistance • Risk of side effects and long term toxicity • Delay = increased rates of transmission? DHHS Guidelines: www.hivatis.org.

  13. Consequences of Anti-retroviral Treatment • Resistance can develop with as little as 30% dose reduction • Prominent cause of HAART failure • Transmission of multi-drug resistant HIV now documented • Public health consequences

  14. Increasing Prevalence of Drug Resistance in Primary HIV Infection Little et al NEJM 2002

  15. 2006 DHHS Guidelines CD4 HIV RNA Recommendation <200 Any Value Treat >200, <350 Any Value Treatment may be offered, though controversy exists >350 >100,000K Possibly initiate due to high HIV RNA; may defer until lower CD4; clinical outcomes data lacking >350 <100,000K Generally defer DHHS Guidelines. 2006

  16. 100% 80% 60% 3-Year Probability of AIDS 40% < 200 < 200 201 - 350 201 - 350 20% 351 - 500 351 - 500 501 - 750 501 - 750 0% > 750 > 750 CD4 count CD4 count > 55K 20-55K 7-20K 1.5-7K < 1.5K (cells/μL) (cells/μL) HIV-1 RNA Concentration (copies/mL) 100% 80% 60% 3-Year Probability of AIDS 40% 20% 0% > 55K 20-55K 7-20K 1.5-7K < 1.5K HIV-1 RNA Concentration (copies/mL) HIV and ART: Risk vs Benefit 3-Year Risk of AIDS With No Treatment 3-Year Risk of AIDS With First HAART Mellors JW et al. Ann Intern Med. 1997;126:946-954.Egger M et al. Lancet. 2002;360:119-129.

  17. Case • Based on immunologic guidelines, I would recommend continued watchful waiting for AK. He may be able to avoid initiating ART for 3-6 years. • However, AK still wants to start ART to reduce his sexual risk of transmission

  18. Transmission of HIV • Infectious Body Fluids • Blood, Semen, Vaginal Fluids, Breast milk • Routes of Transmission • Unprotected sexual intercourse (oral, vaginal, and anal) • Exchange of Blood or Blood Products (ie, sharing needles, body piercing/tattoo) • Perinatal transmission during pregnancy and delivery, or after birth through breast feeding

  19. Risk of Specific Exposures Per Contact TransmissionRate • Receptive Anal 0.8 - 5% • Insertive Anal < 0.1 - 1% • Receptive Vaginal < 0.1 - 1% • Insertive Vaginal 0.01 - 5.6% • Shared Needles 0.67 - 10% • Occupational NS 0.3% • Receptive Oral ???

  20. Effect of viral load on HIV transmissibility Ratios of Risk for Transmission and Acquisition of HIV Among Discordant Couples • <3,500 Referent • 3500-9999 5.8 • 10,000-49,999 6.91 • >50,000 11.87 • Per log increment in VL= 2.45 • See MMWR, July 18, 2004.

  21. Mean change in HIV RNA and CD4+ 6 months after superinfection +1.6 log10 c/mL –132 cells/mm3 ΔCD4+ (cells/mm3) ΔRNA (log10 c/mL) p=0.05 vs controls without superinfection HIV superinfection • Superinfection recently described in the literature1−4 • 3 of 78 (4.1%) patients in the first 6 to 20 months of infection in San Diego and Los Angeles5 • 1 of 32 (3.1%) newly infected subjects from the MACS6 • CD4+ progressed to <200 cells/mm3 2.4 years postinfection • Implications: • Counseling of HIV-infected partners 1. Altfeld M, et al. Nature 2002;420:434; 2. Jost S, et al.NEJM 2002;347:731; 3. Koelsch K, et al.AIDS 2003;17:F11; 4. Ramos A, et al. J Virol 2002;76:7444; 5. Smith D, et al. 11th CROI, San Francisco 2004, #21; 6. Gottlieb G, et al. ibid, #454

  22. Unprotected anal sex Unprotected anal sex, multiple partners Rectal gonorrhea Early syphilis Increasing rates of high-risk behavior and STDs in San Francisco STDs, high-risk behavior, in MSM1 Predictors of high-risk behavior among HIV+ individuals2 40 35 30 • Belief that undetectable VL reduces transmission vs no change in transmission: AOR 5.9 (95% CI 1.9–19) • Most recent VL undetectable vs detectable: AOR 9.3 (95% CI 2.3–37) 25 Percent 20 15 10 5 0 97 98 99 2000 2001 250 200 150 No. patients 100 50 0 97 98 99 2000 2001 1. Gibson S, et al. XIV Int AIDS Conference, 2002, #3430; 2. Colfax G, et al. ibid, #3445

  23. Primum Non Nocere- First Do No Harm • So-called Hippocratic injunction • Axiom central to medicine • Balance of harms vs the benefits of therapy • Growth of use and relevance • Mostly in 20th century especially after Nazi atrocities • Used in almost all medical schools as a graduation oath • IOM concern study about medical errors (1999) • Contemporary focus on risk/benefit and cost/benefit analysis • Concern that the directive emphasizes errors of commission over errors of omission

  24. Harm Reduction • Relatively new social policy (1920’s England, 1950s Canada, 1960s USA) • Methadone maintenance to reduce harm associated with heroin • 1990s • Needle exchange programs for IDUs • Pragmatic approaches that focus on the consequences of harmful behavior and not whether the behavior is “right” or “wrong” • Neither condones nor condemns behavior Marlatt, 1999

  25. Harm reduction Traditional strategies have limited effect, with unattainable goals Recognizes the structural inadequacies in society (poverty, access to care, discrimination) Compatible with health promotion Patient centered and “user-friendly” “Low threshold” access to treatment Abstinence model Goals are clearly stated Avoids ambiguous recommendations Avoids condoning unhealthy choices Based on moral idealism? Harm Reduction

  26. To start ART Reduces progression to AIDS May reduce the risk of HIV transmission and acquiring a HIV super-infection May encourage riskier behaviors Exposes patient to side effects, toxicity, and potential development of resistance To delay ART Prevents side effects and toxicity from ART Avoids potential to develop resistant virus Avoids “Exhausting” available treatments before they may have their greatest value/need May be at greater risk to transmit HIV or acquire a superinfection CaseHarm Reduction VsFirst Do No Harm

  27. Any thoughts on which approach to employ?

  28. Case • AK was offered ART and elected to start Atripla (Tenofovir, Emtricidabine, Effaverenz) one pill PO qhs. • AK was counseled regarding the risks and side effects of ART • AK was counseled regarding the continued need for safer sexual practices

  29. Case • AK called 10 days later complaining of acute onset of an erythematous pruritic rash on his back progressing to chest and legs. • Diagnosed with drug erruption • Atripla discontinued • Prescribed Prednisone and H1-blocker • AK was anxious to start another ART regimen

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