HIV Treatment Update 2013:

What’s new?

Christopher Vinnard, MD MPH MSCEAssistant Professor of MedicineDivision of Infectious Diseases & HIV MedicineDrexel University College of Medicine

A new report of a cure...

Functional HIV Cure after Very Early ART of an Infected Infant

Infant exposure to HIV was confirmed through review of maternal HIV antibody and plasma viral load testing

Infant infection was documented by plasma viral load testing

ART (Combivir + Nevirapine) initiated in the infant at 30 hours of age

Persistence of HIV following treatment discontinuation was assessed using plasma viral load, proviral DNA, and HIV antibody testing

Ultrasensitive assays done at age 24 and 26 months

CROI 2013

Results

Infant infection was confirmed by positive HIV DNA and RNA testing on 2 separate blood samples obtained on 2nd day of life

3 additional plasma viral load tests on day 7, 12, and 20 were positive, before reaching undetectable levels at age 29 days

Plasma HIV RNA remained undetectable between months 1 through 26, despite discontinuation of ART at age 18 months

A “functional cure”

Ultrasensitive methods found a single copy of HIV RNA in plasma at age 24 months

Replication-competent virus was not detected following co-culture of 22 million purified resting CD4+ T cells

Plasma viral load, PBMC DNA, and HIV-specific antibodies remained undetectable with standard clinical assays

Why did this approach work?

What about the first patient cured of HIV infection?

New approaches to treatment: Targeting the CCR5 Receptor

HIV binds to the CCR5 receptor to enter immune cells

“When to start treatment?”

New recommendations

Understanding the alphabet soup of recommendations

When to start: Overall

What are the reasons for this new recommendation?

Benefit to the patient AIDS defining events Cancers All cause mortality

Benefit to the patient’s partner ART was 96% effective in reducing

transmission between discordant couples

Prevention of HIV-1 Infection with Early Antiretroviral Therapy

When to start: Specific conditions

When to start: Opportunistic infections

A new one-pill-once-daily regimen

Percentage of patients with undetectable viral loads

Mean change of CD4 from baseline

Change in kidney function

A new indication for antiretroviral therapy

Take home message

From 2 years ago...

Why not 100% protection? Adherence

http://www.cdc.gov/hiv/prep/

What is a REMS?

Risk Evaluation and Mitigation Strategy

Manage known or potential serious risks with a drug or biological product

FDA sometimes determines that a REMS is needed in order for the benefits to outweigh the risks of an approved drug

REMS may include: Medication Guide, Patient Package Insert, communication plan, and other elements to assure safe use

https://www.truvadapreprems.com/#

New treatments (and new drug-drug interactions) for hepatitis C co-infection

HIV and Hepatitis C

~30% if HIV-infected individuals in the U.S. are co-infected with hepatitis C

Chronic hepatitis C infection is a leading cause of liver disease and mortality in HIV-infected patients

HIV/hepatitis C co-infected patients are at greater risk for liver disease and death, compared with hepatitis C patients without HIV infection

Improved sustained virologic response with the new treatments in HIV/hepatitis C co-infected patients

Telaprevir + PegIFN/Ribavirin

PegIFN/Ribavirin

Boceprevir + PegIFN/Ribavirin

PegIFN/Ribavirin

Beware drug-drug interactions!

For now, three options

Telaprevir NRTI backbone plus either raltegravir,

efavirenz, atazanavir/ritonavir, etravirine, or riplivirine

With efavirenz, increase dose of telaprevir

Boceprevir NRTI backbone plus raltegravir

Wait... New treatments on the horizon for 2014

So what’s new in 2013?

New report of a cured patient New research towards a “functional cure” New guidelines for “when to start” therapy

in different patient populations New one-pill-once-daily treatment regimen New indication for antiretroviral therapy

Pre-exposure prophylaxis New hepatitis C treatments, and new drug-

drug interactions with antiretroviral therapy

Newest member of the Vinnard family

Thank you!