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Brazil switching everyone from Kaletra to Darunavir - Can I keep my existing NRTI + NNRTI (4th combo - 15 years success)

Oct 21, 2017

Hello Dr. Young - Thanks for your great work on this forum!

I'm 55yo male, 21 years HAART, on 4th combo, 15+ years VL ud, CD4 600-800. Latest labs all normal - liver (TGO, TGP), lipids (HDL, LDL, TG), urea. (Maybe due to "paleo" diet?) I'm in Brazil - now they no longer offer Kaletra, switching everyone to Darunavir/Ritonavir. I want to minimize changes - just switch Kaletra to Darunavir/Ritonavir and keep everything else unchanged (currently AZT/3TC + Efavirenz). My doc/pharmacist here might want to remove the Efavirenz - but apparently "DRV/r + 2 NRTIs + NNRTI" does exist:

http://i-base.info/blog/2016/01/who-2015-guidelines-newly-recommended-generic-art-products-on-the-way-for-adults/

History: Dx AIDS 1995: VL 500,000, CD4 nadir 1, diarrhea / cachexia (160 -> 130 lb), oral candida, disseminated Kaposi's.

1st combo 1996-1998: Nelfinavir + AZT + d4T (switched d4T to 3TC due to neuropathy). 1997 Thalidomide (anti-angiogenesis) for Kaposi's. Rapid improvement: CD4 > 200, VL undetect, Kaposi's resolved, weight again 160 lbs.

2nd combo 1998-2000: Norvir/Saquinavir (liquid) + AZT/3TC + Efavirenz.

3rd combo 2000-2017: Kaletra (6 pills a day due to PK with EFV) + AZT/3TC + Efavirenz (+ Loperamide for gastro). In 2015 briefly switched AZT to Tenofovir due to slight lipoatrophy but reverted to AZT due to bad kidney lab values (urea).

Now Brazil public health system is switching everyone off Kaletra onto Darunavir/Ritonavir.

Due to personnel shakeup at my clinic, they gave me new Doc who's not HIV specialist. Doc made error on first Rx: wrote DRV instead of DRV/RTV. I printed out guidelines from the web and got Doc to correct the script. RTV boosts DRV 14-fold - so DRV without RTV would have only 1/14 the concentration - which sounds dangerous!

https://www.google.com.br/search?dcr=0&source=hp&q=darunavir+ritonavir+14+fold

I haven't switched combos yet - still gathering info and considering options.

Questions:

(1) Can I keep the rest of my combo unchanged? - ie Would Darunavir/Ritonavir (600/100 BID) + AZT/3TC + Efavirenz make sense?

The Brazilian HIV pharmacopeia is somewhat behind the USA - but still has many options:

http://azt.aids.gov.br/documentos/siclom_operacional/Solicitacao_Medicamento_SICLOM_nova%20vers%C3%A3o%20FEV_2017.pdf

With 15 years viral suppression, good labs, and minimal side effects (just gastro/diarrhea controlled by Loperamide, "vivid dreams" due to Efavirenz)... my philosophy is "If it ain't broke, don't fix it".

Darunavir/Ritonavir sounds good due to resistance profile and less gastro side effects. I want to minimize changing a 15-year successful combo, just swap one PI for another - keeping current 2 NRTIs + NNRTI unchanged.

(2) Should I get a genotype test before switching? Brazil public system only offers genotype when switching to DRV/r after virological failure. Current Doc (the one who didn't know that DRV requires RTV) probably won't order genotype test - but previous doc (now gone after personnel shakeup) gave me email address of top genotype expert in Sao Paulo and encouraged me to contact them. So maybe I could get a genotype test here if I really tried. I think ti would be safest to check for any RAMs (Darunavir Resistance-Associated Mutations) before switching.

Thanks for any help!

Response from Dr. Young

Hello and thanks for posting from Brazil.

Darunavir/ritonavir is a better tolerated, and generally more potent boosted protease inhibitor than the older lopinavir/ritonavir combo (Kaletra, Alluvia). There should be no reason why switching from Kaletra to a darunavir combination should be problematic, and I'd actually expect tolerability and side effects to be improved.

1) So, yes, you should be able to maintain the rest of your regimen, though the need for all 4 antivirals should be assessed by reviewing previous treatments/treatment failures and drug resistance profiles. Many people wind up on 4 drug regimens because of the goal of having 3 fully active medications, but with some drugs (boosted PIs and integrase inhibitors), this requirement may not be absolute.

2) Conventional genotype testing won't work if your viral load is low, or undetectable. Here in the US, we can obtain an archived genotype which can reveal resistance mutations in people with undetectable viral loads.

I hope that's a helpful start. Feel free to write back. BY



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