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18 oktoober 2018, 13:38

IDWeek-2018 presented new data confirming the long-term effectiveness of ART-schemes “in one pill”

IDWeek-2018 presented new data confirming the long-term effectiveness of ART-schemes “in one pill” - pilt 1

According to a number of studies presented at the IDWeek-2018 conference in San Francisco, several newest ARV-schemes “in one pill” are capable of supporting an undetectable burden of HIV for two years or more.

Two phase 3 clinical trials showed that most people who took Biktarvy or Delstrigo as a first-line therapy had an undetectable viral load for 96 weeks.

Another study showed that Symtuza had worked effectively for two years in people who had changed the ARV regimen.


Biktarvy as first line therapy

David Wol of the University of North Carolina presented the latest results of comparing the same type of Biktarvy and Triumeq schemes in a group of 629 people who started therapy for the first time from Europe and North America. The first 48-week results were presented at the International Conference on HIV / AIDS (IAS 2017) last summer.

Biktarvy contains the latest generation integrase inhibitor bictegravir, emtricitabine (FTC) and tenofovir alafenamide (TAF), a new formula that has less toxicity to the kidneys and bones than the older tenofovir disoproxil fumarate (TDF). Triumeq consists of an integrase inhibitor dolutegravir plus abacavir and lamivudine (3TC).

The majority of study participants (90%) were men, and their average age was 32 years. The mean CD4 count was about 450 cells / mm3, but 10% had less than 200 cells / mm3, indicating a significant immune damage.

At week 96, 87.9% of Biktarvy recipients and 89.8% of Triumeq recipients had HIV RNA of less than 50 copies / ml, demonstrating that Biktarvy is not inferior to Triumeq.

David Wol noted that both regimens performed equally well in groups of people who started treatment with a high or low viral load. Virological resistance was rare (0.6% and 2.2%, respectively), and no new resistant mutations were recorded in any treatment group. The observation is scheduled to continue until 144 weeks.

The treatment was safe and well tolerated. No one in the Biktarvy group stopped it due to adverse events, while in the Triumeq group, five refused.

In the Biktarvy group, adverse events associated with drugs were reported less frequently (28% vs. 40%, respectively). The most frequent side effects in both groups were diarrhea, headache, nausea, and upper respiratory tract infections.

Glomerular filtration rate (eGFR) - a key indicator of the normal functioning of the kidneys, showed no clinically significant changes in both groups.

Also, the decrease in bone density after the start of treatment was small and virtually identical in those taking Biktarvy and Triumeq.

And only the level of total cholesterol and LDL in the Biktarvy group increased significantly, however, only about 4% of those who took ARVT were put on appropriate therapy that lowered the level of lipids.

“These results for Biktarvy provide additional evidence of longer-term safety, efficacy, and high resistance barriers in people living with HIV-1,” the researchers conclude.


Delstrigo as first line therapy

Kathleen Squires from Thomas Jefferson University in Philadelphia presented at the conference the updated results of a clinical study of the 3rd stage of DRIVE-AHEAD, which assessed the safety and efficacy of first-line antiretroviral therapy with Delstrigo, a new combination containing the latest generation reverse transcriptase inhibitor in one tablet (NNRTI) doravirin plus TDF and lamivudine. Delstrigo was approved by the FDA last month.

The study involved 728 previously non-ARVT-positive people. About 85% were men, the average age is 31 years. The CD4 score is approximately 420 cells / mm3. 22% had a high viral load above 100 thousand copies / ml.

All participants were randomly selected to receive Delstrigo and similar Atripla, containing NNRTI efavirenz, TDF and emtricitabine.

Ms. Squires reported on the 48-week study results during the IAS-2017 conference. At IDWeek 2018, she reported 96-week results, showing that 77.5% of Delstrigo recipients and 73.6% of Atripla recipients still had a viral load of less than 50 copies / ml.

The lack of response to the virus was insignificant in both groups (9% and 8%, respectively), and less than 2% developed resistance to doravirine and the nucleoside reverse transcriptase inhibitor.

Delstrigo has been shown to be safe and well tolerated with long-term use.

By week 96, the ratio of people from the Delstrigo and Atripla groups who reported adverse events associated with taking the drug was 32% versus 65%, respectively. The difference was largely due to fewer neuropsychiatric side effects when taking Delstrigo, including dizziness (10% versus 38%), sleep disorders (14% versus 28%), abnormal dreams (5% versus 12%) and altered consciousness (5% versus 9 %).

The cholesterol and triglyceride levels in the Delstrigo group, unlike Atripla, remained virtually unchanged.


Symtuza as a new treatment option

Joseph Eron of the University of North Carolina presented the long-term results of the EMERALD study, which evaluated the ARV drug Symtuza, the first drug based on a protease inhibitor containing darunavir, cobicystat as a booster, TAF and emtricitabine.

Within the framework of Stage 3, 1141 patients from Europe and the USA participated. Over 80% of them were men, about 46 years old. All of them were HIV-positive for nine years and had a long history of treatment. The mean CD4 in the group of volunteers was 628 cells / mm3.

At baseline, all participants should have had a viral load below 50 copies / ml for at least two months. The majority (70%) have already taken boosted darunavir in a regimen with a few pills, and 22% were on boosted atazanavir. Another 8% had previously taken lopinavir / ritonavir.

All patients were randomly assigned to either their previous schemes or Symtuza.

At last year’s IDWeek conference, Joseph Eron presented the first 48-week study results. At that moment, those who remained in their basic mode could also switch to Symtuza.

At a conference in San Francisco this year, he reported that after 96 weeks, 91% of patients randomized by Symtuza still had HIV RNA of less than 50 copies / ml. Only 3.1% did not respond to therapy and 0.5% reached 200 copies / ml. No new HIV mutations were recorded.

The treatment was generally safe and well tolerated. At week 96, 22% of those who received Symtuza said they experienced side effects associated with the drug, but less than 1% of them could be considered serious. Only 2% of patients stopped taking medication.

Scientists did not record any clinically significant changes in eGFR after 96 weeks, bone density increased by more than 3% after the participants switched to Symtuza.

Cholesterol and triglyceride levels also increased after switching, but their growth stopped after 48 weeks.

“The 96-week results of the EMERALD study show that Symtuza can offer HIV-positive people with undetectable viral load a single pill option that can help them maintain high rates of virus suppression over time,” said Eron.

New data from the long-term AMBER study, evaluating Symtuza in a group of HIV-positive first-line people, will be presented at the Glasgow HIV congress later this month.

Autor: Ivan Shangin

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