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IAS 2017: Boosted Darunavir Plus Lamivudine Matches 3-Drug Regimen


A combination of darunavir/ritonavir and lamivudine was just as effective as the same combination plus tenofovir, according to 24-week results from the ANDES study, presented at the recent 9th IAS Conference on HIV Science (IAS 2017) in Paris.

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Pedro Cahn and his research group in Argentina have been investigating the use of 2-drug antiretroviral therapy (ART) regimens consisting of boosted protease inhibitors or integrase inhibitors combined with lamivudine (3TC). These regimens offer potential advantages including saving money and sparing long-term side effects of tenofovir disoproxil fumarate (TDF), the drug most commonly employed as the third agent in first-line antiretroviral treatment.

The GARDEL study showed that the combination of lopinavir/ritonavir (Kaletra) plus lamivudine was non-inferior to the 3-drug combination of lopinavir/ritonavir, lamivudine, and a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) after 48 weeks of follow-up.

An Italian study, ATLAS, reported last year that the combination of atazanavir (Reyataz)/ritonavir and lamivudine was non-inferior to atazanavir/ritonavir and 2 NRTIs after 48 weeks.

The GEMINI 1 and 2 studies are currently investigating whether the integrase inhibitor dolutegravir (Tivicay) with lamivudine is non-inferior to a 3-drug regimen dolutegravir, tenofovir DF and emtricitabine (the drugs in Truvada). If successful, dolutegravir plus lamivudine could be the cheapest drug combination available for treatment in lower-income and lower-middle income countries, due to the low costs of manufacturing both drugs.

However, patent restrictions may not permit the sale of a generic version of dolutegravir in some upper-middle income countries. Use of a boosted protease inhibitor combined with lamivudine may offer an attractive alternative for first-line treatment.

Darunavir (Prezista) boosted with ritonavir or cobicistat is recommended as an option for first-line treatment in U.S. and European guidelines due to its high barrier to resistance.

The ANDES study randomized 145 previously untreated people with HIV in Argentina to receive either darunavir/ritonavir (800/100 mg once daily) plus lamivudine (300 mg once daily) or darunavir/ritonavir (800/100 mg once daily) plus tenofovir (300 mg) and lamivudine (300 mg).

The study population was predominantly male (91%), men who have sex with men (73%), and relatively young (median age 30). Just under a quarter of participants had a high viral load (>100,000 copies/mL) and the median CD4 cell count was 383 cells/mm3.

In this study, participants received a fixed-dose combination of darunavir/ritonavir manufactured by the Argentinean generic drug maker Richmond Laboratories and a generic form of lamivudine. The generic darunavir product is licensed in Argentina as bioequivalent to the branded product Prezista plus ritonavir and is marketed as Virontar N.

The primary outcome of the study is the proportion of participants in each treatment arm with a viral load below 50 copies/mL by intent-to-treat analysis at week 48. Cahn presented results of a secondary endpoint, the proportion of participants with a viral load below 400 copies/mL at week 24.

There was no significant difference in viral suppression at week 24: 95% in the 2-drug arm and 97% in the triple-therapy arm had undetectable viral load. There was only 1 case of virological failure, in the 3-drug arm.

Four participants in the 2-drug arm discontinued treatment for other reasons (1 due to rash, 1 due to a serious adverse event unrelated to the study drug, 1 withdrew from the study, and 1 was lost to follow-up).

Drug-related grade 2 or 3 adverse events occurred more frequently among those who received 3-drug therapy (21 vs 11 events), with neurological and gastrointestinal adverse events largely accounting for the difference. Rash occurred with similar frequency in each study arm (8.0% vs 7.1%). There were no drug-related serious adverse events in either arm.

The study is continuing to a second phase in which 190 additional participants will be randomized and all participants will be followed for 48 weeks to determine if the combination of darunavir/ritonavir and lamivudine is non-inferior to 3-drug therapy in longer-term follow-up.



P Cahn et al. Dual therapy with darunavir/ritonavir plus lamivudine for HIV-1 treatment initiation: week 24 results of the randomized ANDES study. 9th International AIDS Society Conference on HIV Science.Paris, July 23-26, 2017. Abstract MOAB0106LB.