The ANDES study shows that the least expensive therapy is a "safe and well-tolerated" option.
By Ed Susman
MONTREAL — A two-drug combination using a generic formulation of the protease inhibitor darunavir/ritonavir plus lamivudine appeared to control HIV as well as the same combination with tenofovir added, according to results from the Phase IV ANDES trial reported here.
En el análisis por intención de tratar, el 91 % de los pacientes que recibieron la terapia dual lograron cargas virales indetectables usando el ensayo de 50 copias a las 48 semanas en comparación con el 93 % de los que recibieron la terapia triple ( P <0,01 para no inferioridad), dijo Maria Inés Figueroa, MD, de la Fundación Huesped en Buenos Aires, Argentina.
Y en el análisis por protocolo, las tasas de carga viral indetectable fueron del 98 % y 99 %, respectivamente ( P <0,01 para no inferioridad), anotó.
In a post-hoc evaluation of patients with higher viral loads at the start of the study, approximately 90% of patients on triple therapy achieved undetectable viral loads, compared with 87% of those receiving two-drug therapy, he added, explaining that the difference was outside the range of non-inferiority criteria.
"These results support the darunavir/ritonavir regimen as a potential therapeutic option for subjects who have never previously received antiretrovirals, at least for patients with a viral load below 100,000 copies/mL at baseline," he said at the International AIDS Conference.
"It's excellent to see the long-term results with generic darunavir-lamivudine," said session moderator Chloe Orkin, MD, of Queen Mary's University London.
"The message here, really, is that an inexpensive drug can have good results in treating people with HIV and that there is more than one two-drug therapy regimen besides dolutegravir that can be used to maintain HIV suppression," he told MedPage Today . "It's an important finding."
The open-label, randomized ANDES trial included 336 antiretroviral-naïve patients recruited from seven sites in Argentina. A total of 171 were assigned to receive dual therapy with darunavir 800 mg/ritonavir 100 mg in a fixed-dose combination plus lamivudine 300 mg, and 165 received triple therapy with the treatment plus tenofovir 300 mg.
The patients had a median age of 36 years and about 90% of the cohort were male.
Approximately 93% of patients enrolled in ANDES had CDC stage A disease, and approximately 23% had more than 100,000 copies/mL of circulating HIV RNA.
A total of seven patients experienced virological failure: three in the triple therapy group and four in the dual therapy group. Of the patients who experienced virological failure, three in the dual therapy group and two in the triple therapy group did not achieve undetectable viral loads.
The increase in CD4-positive cells, a marker of immune system health, was similar in both groups, Figueroa reported. Those receiving triple therapy achieved an average of 238 cells/ mm³ , while those receiving only triple therapy saw an average increase of 275 cells/ mm³ ( P = 0.442), a non-significant difference.
The dual therapy strategy was “safe and well tolerated,” he said. As anticipated, grade 2/3 adverse events were more frequent in the triple therapy arm (19% vs. 12% with dual therapy, P = 0.04). Patients in the triple therapy group also reported more abdominal pain.
The lipid profiles and abnormalities in liver enzyme tests were similar in both arms of the trial, he reported.