Offering ARV Treatment to All HIV-infected Persons in San Francisco Grant Colfax, MD Director of HIV Prevention and Research San Francisco Department of.

Offering ARV Treatment to All Offering ARV Treatment to All HIV-infected Persons in San FranciscoHIV-infected Persons in San Francisco

Grant Colfax, MDDirector of HIV Prevention and Research

San Francisco Department of Public Health

Institute of Medicine HIV Screening and Access to Care WorkshopJune 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 vs. >500 (n = 9,155) Relative risk 1.94 (95% CI 1.37-2.79) of death

CD4 <350 vs. 350-500 (n = 8,362) Relative risk 1.69 (95% CI 1.26-2.26) of death

Kitahata, et al., NEJM, 2009

Risk for death decreased if therapy started when CD4 > 500 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 effectsViral replication can do more damage than drug side effects

HIV Prevalence, by Region and Subgroup

Adapted from: El-Sadr, et al., NEJM, 2010

Parameters 2004 (%) 2008 (%)

Among MSM, HIV Test in Last 12 mos. 65 71

HIV-Positive People Unaware of Status 24 15-20

Linkage to Care 88% (2006–2007)

Engaged in Care 71 78

ART Coverage (PWA) 74 (2005) 90

Virologic Suppression 52 (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.

92% 92%87% 87%

93%88%

92% 92%

85%

93%

86%90% 88%

88% 88% 86% 84%89%

84%87%

90%

80%

89%

80%

87% 87%

0%

10%

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30%

40%

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60%

70%

80%

90%

100%

% R

ec

eiv

ing

AR

T

High Level Estimate* Low Level Estimate

70% 71%60% 65%

74%

61%69%

60%

73%

59% 62% 66%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

% R

ec

eiv

ing

AR

T

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

Charlebois, CROI, 2010

Donnell, et al., Lancet, 2010. Abstract #136.

Das, et al., PloSOne, 2010

GROUP Avg. Expend $ per Client

Clients % Clients

ADAP Only $13,572 1,986 44.68%

Medi-Cal $6,349 67 1.51%

Private Insure $2,784 957 21.53%

Medicare $3,288 1,435 32.28%

TOTAL $7,820 4,445 100.00%

Source: California State Office of AIDS

CD4 Count: 350-500 CD4 Count >500

ART Number (%) 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