EACS 2013: Dual Therapy with Kaletra + Lamivudine Works Well Regardless of Viral Load

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A dual combination of lopinavir/ritonavir (Kaletra or Aluvia) plus lamivudine (3TC or Epivir) as first-line therapy produced good virological suppression regardless of baseline viral load and was well-tolerated in the multinational GARDEL study, according to a late-breaking report at the 14thEuropean AIDS Conference this week in Brussels.

Triple regimens including 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) are the standard of care for antiretroviral therapy, but most NRTIs can cause side effects and simplifying treatment may improve adherence and reduce cost. Lopinavir/ritonavir as monotherapy has been shown to be inferior to standard therapy, but including 1 NRTI may be adequate.

Pedro Cahn from Fundacion Huesped in Buenos Aires and fellow investigators with the GARDEL Study Group compared the safety and effectiveness of a dual combination versus triple therapy for treatment-naive patients with stable viral suppression.

This randomized open-label Phase 3 study included 426 previously untreated patients in Argentina, Chile, Mexico, Peru, Spain, and the U.S. Nearly 85% were men (about 60% men who have sex with men and 35% heterosexual) with a median age of about 35 years.

The median baseline CD4 T-cell count was approximately 325 cells/mm3, 43% had high viral load (HIV RNA >100,000 copies/mL), and only 3% had a history of AIDS. People with NRTI or protease inhibitor resistance mutations at baseline were excluded.

Participants were randomly assigned to receive 400/100 mg lopinavir/ritonavir plus 150 mg lamivudine, both taken twice-daily, or a standard regimen of lopinavir/ritonavir plus 2 NRTIs in a fixed-dose combination. About 9% used abacavir/lamivudine (Epzicom or Kivexa), 37% used tenofovir/emtricitabine (Truvada), and the rest (54%) used zidovudine/lamivudine (Combivir).

Cahn explained that NRTI choice was based on national treatment guidelines in the various countries. While Combivir is no longer considered a preferred option in the U.S. and Europe, it is still used in middle- and lower-income countries.

Results

"Our results demonstrate that dual therapy with lopinavir/ritonavir + 3TC was non-inferior to triple therapy after 48 weeks of treatment, regardless of baseline viral load," the researchers concluded. "The dual therapy regimen showed fewer discontinuations due to safety and tolerability."

"Virologic failure, occurring at similarly low levels in both treatment arms, did not result in protease inhibitor resistance development, preserving a wide range of drugs for 2nd line antiretroviral therapy," they added.

Amongst NRTIs, lamivudine is very well tolerated. Cahn noted that the dual regimen does not require monitoring for kidney, liver, or blood cell toxicities, making it a useful option in settings with limited monitoring capacity.

10/19/13

Reference

Cahn P et al (GARDEL Study Group). Dual therapy with lopinavir/ritonavir (LPV/r) and lamivudine (3TC) is non-inferior to standard triple drug therapy in naive HIV-1 infected subjects: 48-week results of the GARDEL study. 14th European AIDs Conference (EACS 2013). Brussels. October 16-19, 2013. Abstract LBPS7/6.

Other Source

Fundacion Huesped. Successful new strategy based on dual therapy shows non-inferiority compared to standard of care triple combination in ARV-naive patients. Press release. October 18, 2013.