November’s Antiretroviral Therapy CE at NYY Steakhouse, Manhattan, NY

The second November continuing education event was held at NYY Steakhouse near Rockafeller Center. The beautiful venue and evening, rich with New York Yankees history, was coordinated by President, Dr. Amisha Arya. Dr. Arya opened the event by introducing the evening’s speaker, Craig R. Ballard, PharmD, joining us from University of California San Diego. Dr. Ballard is an HIV specialist who works at UC San Diego’s Owen Clinic. The evening’s CE presentation was titled “New and Emerging Therapies for the Clinical Management of HIV Infection.” Dr. Ballard first gave an overview on the HIV diagnosis criteria.

The DDHS guideline recommends treating HIV patients, regardless of their RNA level or CD4 count.

The DDHS recommended Non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen is:

efavirenz/emtricitabine/tenofovir.

Recommended protease inhibitor (PI) regimens are:

atazanavir + ritovavir + emtricitabine/tenofovir or
darunavir + ritonavir + emtricitabine/tenofovir

Recommended Integrase strand transfer inhibitors (INSTIs) regimens include:

raltegravir + emtricitabine/tenofovir,
elvitegravir/cobicistat/emtricitabine/tenofovir,
dolutegravir + abacavir/lamivudine, and
dolutegravir + emtricitabine/tenofovir

The IAS-USA guideline has additional regimens for each of the different classes, in addition to DDHS’ recommended regimens.

Recommended NNRTI regimens:

Rilpivirine/emtricitabine/tenofovir
Efavirenz + abacavir/lamivudine

Recommended PI regimens:

Atazanavir + ritonavir + abacavir/lamivudine

Reommended INSTIs regimens:

Same as DDHS

Limitations to recommended therapy include drug-drug intersections, rash, low barrier to resistance with efavirenz-based and elvitegravr-based regimen. Raltegravir, ritonavir, and dolutegravir have adherence issues because they are not available as single tablet agents.

Potential therapeutic targets include the integrase inhibitors, reverse transcriptase inhibitors, protease inhibitors, fusion inhibitors, and CCR5 inhibitors. These are areas of development for research. Dr. Ballard proceeded by discussing new anti-retroviral formulations by comparing study designs and findings, which are highlighted below.

The ECHO study compares Rilpivirine + Emtricitabine/Tenofovir vs. Efavirenz 600mg + Emtricitabne/Tenofovir. Rhe THRIVE study compares Rilpivirine 25mg + 2NRTIs vs. Efavirenz 600mg + 2NRTIs. There was no significance difference in HIV RNA between the two arms for each of the studies at week 48 or at week 96. There was a higher failure rate, by not achieving less than 50 copies/ml, seen in the rilpivirine arm. Rilpivine had less CNS and psychiatric adverse effects and lipid abnormalities compared to Efavirenz.

Study 111 selected patients who were on efavirenz/emtricitabine/tenofovir and switched them to rilpivirine/emtricitabine/tenofovir. The single-tablet had record of resistance, but had no discontinuations based on adverse effects.

The SPIRIT study compared Emtricitabine/Rilpivirine/Tenofovir vs. PI+Ritonovir + 2NRTIs. The two arms had comparable virologic outcome, but the Emtricitabine/Rilpivirine/Tenofovir arm had more tolerability in adverse effect profile. At 24 weeks, patients on the PI+Ritonovir + 2NRTIs were switched to Emtricitabine/Rilpivirine/Tenofovir and reported higher satisfaction based on gastrointestinal adverse effects.

SPRING-2 compared Dolutegravir 50mg QD + FTC/TDF or ABC/3TC vs. Raltegravir 400mg BID + FTC/TDF or ABC/3TC in treatment naïve patients. The Dolutegravir group in patients who had greater than 100,000 baseline HIV RNA copies/ml had a greater reduction of HIV RNA, compared to raltegravir. Dolutegravir used with FTC/TDF showed greater reduction of HIV RNA compared to the ABC/3TC arm. The adverse effect profile for dolutegravir was similar to raltegravir.

The SINGLE study compared Dolutegravir + ABC/3TC vs. Efavirenz/FTC/TDF in treatment naïve patients with greater than 1,000 HIV RNA copies/ml. The Efavirenz/FTC/TDF showed greater reduction in HIV RNA copies compared to Dolutegravir + ABC/3TC. However, Dolutegravir exhibited a significant CD4 cell gain. Dolutegravir had less occurrences of CNS adverse effects such as dizziness and abnormal dreams.

The SAILING study compared Dolutegravir vs. Raltegravir in treatment experienced patients. Raltregravir showed lower HIV RNA, less than 50 copies/ml, while Dolutegravir demonstrated greater CD4 Cell gain. In patients with greater than 50,000 HIV RNA, Raltegravir exhibited a significant reduction in HIV RNA. In both patients with CD4 < 200 cells/mm3 and CD4 > 200 cells/mm3, Dolutegravir showed a greater increase in CD4 cells. Raltegrvir had a greater resistance profile and virologic failure.

The very educational evening was followed up by a question and answer session led by Dr. Ballard, then society updates by Dr. Arya. The evening concluded with dessert and networking amongst members.