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Presentation Outline ICHP Annual Meeting September 13-15

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DHHS Guidelines, March 2012: When to Start<br />

• Antiretroviral therapy recommended for all HIV‐infected pts; strength of<br />

recommendation varies according to CD4+ cell count or condition<br />

CD4+ Cell Count or Clinical Condition<br />

• CD4 + count < 350 cells/mm³ (AI)<br />

• CD4 + count 350‐500 cells/mm³ (AII)<br />

• CD4 + count > 500 cells/mm³ (BIII)<br />

________________________________________________________________<br />

• History of AIDS‐defining illness (AI)<br />

• Pregnancy (AI)<br />

• HIV‐associated nephropathy (AII)<br />

• HBV coinfection (AII)<br />

• Patients at risk of transmitting HIV to sexual partners (AI, heterosexuals; AIII,<br />

others)<br />

• HCV coinfection (BII)<br />

• Patients > 50 years of age (BIII)<br />

NRTI “Backbone”<br />

Nucleoside Reverse Transcriptase Inhibitors<br />

Truvada > Epzicom p > Combivir<br />

Tenofovir Adverse Effects<br />

• Nephrotoxicity<br />

‐ Vitamin D deficiency, metabolic bone disease<br />

‐ Fanconi Syndrome<br />

Elevated SCr<br />

Proteinuria<br />

Glucosuria<br />

Hypophosphatemia<br />

ls/mm3 CD4+ Cell Count (cell )<br />

Full Immune Recovery Is Associated With<br />

Higher Baseline CD4+ Count<br />

900<br />

800<br />

700<br />

600<br />

500<br />

400<br />

300<br />

200<br />

100<br />

0<br />

Moore R, et al. IAC 2006. Abstract THPE0109.<br />

Baseline CD4+ cell count<br />

< 200 cells/mm 3<br />

201-350 cells/mm 3<br />

> 350 cells/mm 3<br />

0 1 2 3 4 5 6<br />

Year of Follow-up<br />

GS934: Week‐48 Virologic Response<br />

• N = 517 antiretroviral‐naive<br />

patients randomized to:<br />

– TDF + FTC + EFV<br />

– ZDV/3TC + EFV<br />

• Superior efficacy with TDF +<br />

FTC<br />

• More discontinuations for<br />

h HIV-1 RNA<br />

< 400 Copies/mLL<br />

[TLOVR] (%)<br />

AEs with ZDV/3TC Patients With<br />

100<br />

80<br />

60<br />

P = .034<br />

77%<br />

68%<br />

40<br />

20<br />

0<br />

FTC + TDF + EFV<br />

ZDV/3TC + EFV<br />

(ITT n = 509)<br />

BL 8 16 24 32 40 48<br />

Weeks<br />

NNRTI<br />

Nonnucleoside Reverse Transcriptase Inhibitors<br />

Efavirenz > Rilpivirine > Nevirapine<br />

8/30/2012<br />

4

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