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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%
20%
30%
40%
50%
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