Albuvirtide study china - Interim results weekly HIV med injections

[Jim Allen]

Interim results of weekly HIV treatment injection, interesting.
Would not be something for me but could maybe one day offer a solution to many who have no other means.

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http://www.aidsmap.com/New-long-acting-fusion-inhibitor-albuvirtide-plus-boosted-protease-inibitor-matches-standard-triple-drug-therapy/page/3095149/


The study randomised 389 treatment-experienced individuals who had experienced virological failure of a first-line regimen to receive either a weekly infusion of albuvirtide (dose unspecified) plus twice-daily dosing of the boosted protease inhibitor lopinavir/ritonavir, or a regimen of lopinavir/ritonavir twice daily plus two NRTIs: lamivudine and either tenofovir, abacavir or zidovudine, depending on previous treatment history (72% received tenofovir, 26% zidovudine, 1% abacavir and 1% tenofovir and zidovudine).

The protocol-specified interim analysis took place when half of the target recruitment had completed 48 weeks of treatment. The interim analysis reported on 175 people (83 in the albuvirtide arm and 92 in the triple-drug arm). The median age of participants was 40 years, 73% were male, 16% had CD4 cell counts below 100 cells/mm3 and 12% had baseline viral load above 100,000 copies/ml. Baseline resistance to at least one agent was present in 80% of the albuvirtide group and 83% of the NRTI group, most commonly lamivudine resistance. Genotypic resistance to tenofovir was present in 49% of the NRTI group. Protease inhibitor resistance mutations were detected in 3.8% of the albuvirtide group and 2.3% of the NRTI group.

At 48 weeks 80.4% of the albuvirtide group had viral load below 50 copies/ml by intent-to-treat analysis, compared to 66% in the triple-drug group. The albuvirtide arm was non-inferior to the standard triple-drug regimen in second-line treatment.

No resistance to albuvirtide was detected in the five individuals who had viral load above 500 copies/ml at weeks 24 or 48. One participant in each study arm developed resistance to lopinavir.

Albuvirtide was well tolerated. The most frequent adverse event in the albuvirtide arm was diarrhoea (grade 1 or 2 in 7.5% of individuals, compared to 14.1% in the triple-drug arm). Two cases of headache and two of dizziness were observed in the albuvirtide arm.

Elevated cholesterol was observed more frequently in the albuvirtide aim (11.8% vs 0%) but all elevations were grade 1 or 2. Triglycerides were mildly elevated in around a quarter of participants in each arm.

Dr Dong Xie of Frontier Biotechnologies said that whereas participants taking albuvirtide visited the clinic once a week, those in the triple-drug arm visited the clinic only once every three months, suggesting that those in the albuvirtide arm may have received more reinforcement for good adherence and explaining the trend towards superior virological suppression in this group.

[Jim Allen]

Ugh of course the "headline" in some online media is again incorrectly using the word "cure" when its not...

http://www.itechpost.com/articles/59384/20161130/answer-hiv-authorities-china-approve-1st-long-acting-cure.htm

[Jim Allen]

Update: its being reported that Albuvirtide has been approved in China

https://www.firstwordpharma.com/node/1570731

June 6th, 2018
By: Joe Barber
Tags: Top Story 3BNC117 Aikening albuvirtide Frontier Biotech CFDA AIDS and HIV Marketing & Sales Regulatory Affairs

Frontier Biotechnologies announced the approval in China of the long-acting fusion inhibitor Aikening (albuvirtide) as the first domestically developed drug for the treatment of HIV. The once-weekly injectable agent is designed to be used with other antiretroviral medicines to treat people suffering from HIV who have received antiviral therapy.

In 2016, Frontier Biotech reported that the Phase III TALENT study of Aikening met its primary objective based on an interim analysis. In the trial, Aikening plus ritonavir-boosted lopinavir was shown to be non-inferior to a World Health Organization-recommended second-line three-drug regimen at week 48 in treatment experienced HIV-1 infected adults. The company noted at the time, that patients given Aikening showed statistically better renal safety than those taking the control regimen containing Gilead Sciences' Viread (tenofovir disoproxil fumarate).