According to a study conducted in Catalonia, therapy with dolutegravir plus lamivudine has similar efficacy to triple therapy.
By: Elias El Hage
A study conducted entirely in Catalonia has shown that dolutegravir plus lamivudine therapy has similar efficacy to triple therapy. It does not produce resistance, has no side effects, is cheaper, and may offer a lower risk of long-term toxicity than triple regimens.
The study has been published in the journal The Lancet HIV and has been carried out at the Hospital Clínic / IDIBAPS , which coordinated the study, under the leadership of Esteban Martínez, senior consultant and associate professor of Medicine of the Infectious Diseases Service of the Hospital Clínic of Barcelona and member of the 'AIDS and HIV infection' group of IDIBAPS.
The other participating centers were the Germans Trias i Pujol Hospital, the Sant Pau Hospital, the Bellvitge Hospital, the Vall d'Hebron Hospital, and the Arnau de Vilanova Hospital in Lleida . This research has demonstrated the efficacy of dual therapy with dolutegravir and lamivudine for the treatment of HIV, compared to the standard three-drug treatment – dolutegravir and tenofovir-emtricitabine.
According to a statement released today by the Hospital Clínic, coinciding with the publication of this study, HIV is a disease that affects the cells of the immune system and prevents it from functioning normally. People infected with HIV require lifelong antiretroviral medication, which makes the disease chronic, but does not cure it.
During treatment there is an accumulated risk of toxicity or interactions with other drugs prescribed for other diseases, therefore, the research team of this study considered that dolutegravir did not present a risk of generating important drug interactions , had good tolerability, was a drug with a high barrier to the generation of resistance and did not present time or dietary restrictions.
Dolutegravir is a highly potent, second-generation integrase inhibitor. Integrase is an enzyme found in HIV that allows viral DNA to insert itself into the DNA of our cells, specifically CD4 lymphocytes. Dolutegravir prevents this insertion, thus preventing our immune cells from becoming infected and allowing them to continue performing their protective function. This medication, like other antiretrovirals, reduces the risk of developing Acquired Immunodeficiency Syndrome (AIDS) , other serious infections, or cancer.
In asymptomatic patients
The study participants were adults over eighteen years of age, HIV-positive by serological testing, asymptomatic, receiving standard triple therapy, and well-controlled. Some were switched to dolutegravir monotherapy, others to dual therapy with dolutegravir and lamivudine, and others continued with their triple therapy.
Each participant enrolled in the trial was scheduled for a follow-up appointment at their hospital every 12 weeks, for the 48 weeks the study lasted. Blood tests were performed to detect the amount of viral HIV RNA in plasma, the concentration of immune system cells such as CD4 and CD8 , and other parameters such as glucose, creatinine, insulin, lipids, and vitamin D were also analyzed.
Dolutegravir monotherapy was found to be suboptimal , so the study continued comparing dolutegravir and lamuvidin with standard triple therapy. After 48 weeks, similar efficacy was observed with both treatment regimens, but the double regimen required a lower dose and carried a lower risk of toxicity than long-term triple therapy.
Therefore, switching from triple to dual therapy represented an improvement in the quality of life for patients with HIV. Furthermore, dual therapy with dolutegravir was found not to produce resistance, most adverse effects were mild or moderate, and there were no significant differences in side effects between the two groups.
Patients' weight increased by an average of 1.5 kg with dual therapy compared to triple therapy , but no correlation was observed between weight changes and changes in metabolic parameters. Relevant neuropsychiatric aspects, such as sleep quality, were also unaffected in patients receiving dual therapy compared to those in the other group.
"All studies that aim to improve existing treatments by reducing side effects and toxicity without increasing costs are promising, as demonstrated in this study carried out thanks to the Carlos III Health Institute, the AIDS Research Network, and ViiV Hhealthcare . This clinical trial on HIV treatment is one of the largest in terms of the number of participants (265) conducted in Catalonia, and its findings are expected to have a positive impact on the treatment of people living with HIV," according to the Hospital Clínic.