Regime two dolutegravir drug and well tolerated Inhibitor Reverse Transcriptase Analogous Nucleosídea, lamivudine led to sustained viral suppression for most people in the first intervention of antiretroviral therapy (ART) in a small pilot study, according to a speaker late submission of the XXI International AIDS Conference (AIDS 2016) last week in Durban.
As people with HIV live a treatment throughout life, researchers continue to look for therapies that are better tolerated, easier to take and more affordable.
Viiv Healthcare dolutegravir (Tivicay also in the single tablet Triumeq scheme) is a potent integrase inhibitor with a high barrier resistance. Lamivudine (3TC; Epivir) is an inexpensive and well tolerated reverse transcriptase nucleoside analogues (NRTIs) with minimal side effects known drug interactions and widely available versions of lower-cost generic.
The study GARDEL lpreviously showed promising results using a dual combination of lopinavir / ritonavir (Kaletra) plus lamivudine. But dolutegravir is a more attractive option as IT has less toxicity and interactions drug-to-drug that protease inhibitors.
Pedro Cahn of huésped Foundation demonstrated the findings reported in Buenos Aires from PADDLE study, evidence of "study-concept" evaluating dolutegravir plus lamivudine for initial treatment of HIV.
This 4 phase of the pilot study has twenty participants previously untreated adults with low baseline viral load (criterion<100.000 copies / ml, although 4 were actually above this threshold) and resistance mutations not known NRTIs. All but one were men and the median age was 34 years. The median baseline viral load was about 24.000 copies / ml and CD4 count was approximately 500 cells / mm3. People with hepatitis B were excluded (lamivudine is also active against hepatitis B).
Participants in this study were opened treated with 50 mg lamivudine dolutegravir more 300 mg once a day for 48 weeks. To ensure safety a viral load was initially measured every few days and then every two weeks until the third month. The first ten participants were evaluated in 8 weeks before the next group of ten have started therapy. Treatment was discontinued if patients do not
reached at least a reduction of 1 log viral load at week, and if the viral load remained above 1000 copies / ml at week 12 or above 400 copies / ml at week 24, or if the viral load returned to emerge after becoming undetectable.
Andrew Cahnpresented a preliminary report of the study after 24 weeksin the Parliament of the AIDS conference last October and the results after 48 2016 week in AIDS. The current study has a term of 96 weeks.
- Viral load declined rapidly after initiation of therapy similar to that seen with the decline 3 the standard HAART drugs.
- Most participants had HIV RNA below 50 copies / ml in the third week and everyone - including 4 who started with viral load above 10.000 copies / ml - did so from the eighth week onwards.
- While all had undetectable viral load in 24 weeks in 48 1 weeks person experienced in the protocol, the line definition of treatment failure and 1 committed suicide, resulting in a response rate of 90%.
- The treatment was generally safe and well tolerated with few side effects or laboratory abnormalities.
Andrew Cahn explained that patients with treatment failure was the study discontinued, but your doctor kept the same scheme and it achieved viral suppression without changing therapy. Finally the researchers convinced him to enter a default schema.
The only serious adverse event was a suicide after a traumatic life event by an individual who was found later to have had a history not previously disclosed in suicide attempts; it was considered unrelated to the study drug.
"In this pilot proof of concept study, dual therapy with dolutegravir plus lamivudine achieved rapid viral suppression induced with a favorable safety / tolerability profile in the treatment of HIV-1 virgin -indivíduos ART," the researchers concluded:
"If confirmed in a well powered randomized clinical trial that this system of two drugs can be considered as a simple, powerful, well tolerated and potentially inexpensive strategy for the early treatment of HIV infection."
Andrew Cahn said more larger test data are needed to determine if the dual therapy is a safe and effective strategy. The 3 phase of the GEMINI study (NCT02831673), Which traced its first participant last week, will compare dolutegravir plus lamivudine versus the standard regimen of dolutegravir plus tenofovir / emtricitabine (Truvada drug).
"We have to wait and see," Cahn warned. "Do not do it at home until we have the results."
dolutegravir Antiretroviral is incorporated into the SUS
Medicament 2016 enter into the third line treatment of HIV infection
The dolutegravir Antiretroviral was incorporated into the SUS from the decision of the National SUS Technology Incorporation Commission (Conitec) as third-line drug in the treatment of HIV infection.
The third line of treatment is known as a rescue line. That is, the one indicated on failure patient care with the first and second lines. .. read more
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Translated by Claudio Souza's original Aidsmap:AIDS 2016: dolutegravir Plus Lamivudine Works Well as First-Line HIV Treatment
Reviewed by Mara Macedo