Offering ARV Treatment to All HIV-infected Persons in San Francisco Grant Colfax, MD Director of HIV Prevention and Research San Francisco Department of Public Health Institute of Medicine HIV Screening and Access to Care Workshop June 21, 2010

 Offer antiretroviral therapy to all HIV-infected individuals unless there is a reason not to  Decision to start ART made by patient in conjunction with the provider

 Old paradigm: Drugs are toxic so defer therapy as long as possible  New paradigm: Although new drugs are not completely benign, they are less “toxic” than the virus  Rather than treating only when there was a strong reason to treat, the default is now to treat unless there is a strong reason not to treat

 CD4 500 (n = 9,155)  Relative risk 1.94 (95% CI ) of death  CD4 <350 vs (n = 8,362)  Relative risk 1.69 (95% CI ) of death Kitahata, et al., NEJM, 2009 Risk for death decreased if therapy started when CD4 > 500

 HIV replication leads to liver, cardiac and renal disease  HIV replication is associated with increased risk for malignancies and declines in neurocognitive function  ART is associated with reduced risk of these non-AIDS complications Viral replication can do more damage than drug side effects

HIV Prevalence, by Region and Subgroup Adapted from: El-Sadr, et al., NEJM, 2010

Parameters2004 (%)2008 (%) Among MSM, HIV Test in Last 12 mos.6571 HIV-Positive People Unaware of Status Linkage to Care88% (2006–2007) Engaged in Care7178 ART Coverage (PWA)74 (2005)90 Virologic Suppression52 (2005)72

*Top value of percentage (including the gray area) indicates the proportion of ART use after excluding persons who were lost-to-follow-up.

*Shaded areas indicate patients who are known to have started ART but the type of ART does not refer to the highly active antiretroviral therapy (HAART) or such information is not available.

HIV Infections Averted * Charlebois, CROI, 2010

Donnell, et al., Lancet, Abstract #136.

Das, et al., PloSOne, 2010

GROUPAvg. Expend $ per Client Clients% Clients ADAP Only$13,5721, % Medi-Cal$6, % Private Insure$2, % Medicare$3,2881, % TOTAL$7,8204, % Source: California State Office of AIDS

CD4 Count: CD4 Count >500 ART Number (%) Yes 1,097 (60%)748 (48%) No 753 (40%)825 (52%)

 Over last 12 months  2,621 patients seen  2,169 (83%) already on ART  452 not on ART  1,685 (78%) of those on ART have undetectable HIV viral load  Resistance  Non-adherence  Recently started ART – not undetectable yet  In 2009, there were 501 new patients to PHP  Average CD4 = 426  124 (25%) were on ART at first visit (average CD4 = 375)  302 (75%) not on ART (average CD4 = 442) Courtesy of Brad Hare

 Use electronic medical record (HERO) to capture medication prescribing, medication switches and laboratory response to treatment (CD4 and viral load)  myHERO – patient portal, new features  Annual patient satisfaction survey  Monitor for patients lost to follow up or dropping out of care  Referred to outreach team for support and engagement  Active surveillance for resistance  Collaboration with UCSF virology lab Courtesy of Brad Hare

 Primary care provider (NP, Int Med, FP, ID/HIV)  Social workers  Screening and referral for substance use or mental health concerns (HIV Specialty Psychiatry/Psychology)  Housing, disability, benefits (including ADAP enrollment)  Pharmacist lead ART adherence program  1:1 assessments of barriers, education, medicine reviews, ongoing monitoring  Patient education program and support groups  Linkage to care team  Patient information sheet Courtesy of Brad Hare

Caveats and Challenges  Treatment decisions to benefit individual  We hope for secondary prevention benefits  Emphasis on changing provider behavior  Clinical guidelines don’t necessarily change practice  Pendulum has swung between early vs. deferred treatment several times  Many providers in SF have lived through eras of single, dual, early treatment  We don’t know the best way to encourage providers to adopt guidelines  In communities with more limited resources, it may not be possible to treat all  But we need to change our thinking about tolerating “a little bit” of virus  We don’t deny medications for many other chronic diseases where beneficial outcomes are relatively small or unknown  Community response  In SF, general support  Some patients will refuse tx; that’s OK, if risks/benefits are made clear  Conspiracy theories must be addressed

Testing and treating alone will not eliminate the epidemic… Coates, Lancet, 2008

Acknowledgements and Thanks  SFDPH  Moupali Das  Mitch Katz  Sharon Pipkin  Susan Scheer  Michaela Varisto  UCSF  Steve Deeks  Brad Hare  Diane Havlir  Jeff Sheehey