ViiV

The Access to Medicine (AtM) Foundation last week published a pediatric analysis of additional results from its 2021 AtM Index, finding just 7% of pharmaceutical companies’ R&D is for children under 12, despite significant gaps in treatment options for children.

The report praised GSK, Johnson & Johnson and Sanofi for being “the most active” in developing pediatric versions of products, and also named examples of drugs that “could each make a big difference” for LMICs: Eli…

Merck, Gilead and ViiV captured headlines for their HIV portfolios at this week’s annual Conference on Retroviruses and Opportunistic Infections (CROI).

First, Merck announced on Monday that a reformulated version of its islatravir NRTTI subdermal implant for HIV-1 pre-exposure prophylaxis (PrEP) may provide protection for “at least one year,” based on Phase 1 data. A company researcher told NAM Aidsmap that planned Phase 2 trials of the new version will be “very similar” to the Phase…

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GSK subsidiary ViiV asked the U.S. FDA last week to expand the label of Cabenuva—its long-acting injectable combination HIV regimen (containing ViiV’s cabotegravir and J&J’s rilpivirine)—to allow dosing once every two months in addition to the monthly regimen the regulator approved earlier this year.

The move follows The Lancet’s publication in December 2020 of data supporting bimonthly shots.

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GSK subsidiary ViiV notched U.S. FDA approval last week of Cabenuva, a monthly injectable combination HIV regimen (containing ViiV’s cabotegravir and J&J’s rilpivirine) for adults. The shot was approved by the European Medicines Agency in December 2020 and received a nod from Health Canada in March 2020.

The FDA also approved ViiV’s cabotegravir tablets (Vocabria), which it recommends be taken in combination with oral rilpivirine for one month prior to starting Cabenuva to ensure…

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Findings published in The Lancet last week support the use every two months of the injectable two-drug HIV regimen containing ViiV’s cabotegravir and J&J’s rilpivirine for long-acting maintenance of viral suppression in people living with HIV-1.

The European Medicines Agency also gave GSK subsidiary ViiV a nod for Rukobia (fostemsavir)—the company’s novel attachment inhibitor for the treatment of adults with multidrug-resistant HIV-1—after studies showed the medication achieved…

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GSK subsidiary ViiV and the UN-backed Medicines Patent Pool announced Monday their signing of a “first-of-its-kind” voluntary licensing agreement to allow four upper-middle-income countries to buy generic versions of HIV regimens containing ViiV’s dolutegravir.

Under the deal terms, “selected generic manufacturers” can supply medicines recommended by WHO or the U.S. Department of Health and Human Services to Azerbaijan, Belarus, Kazakhstan and Malaysia at a “significantly reduced price…

Gilead, GSK’s ViiV subsidiary and Merck all made HIV product announcements this week.

First, Merck said Monday that the Gates Foundation will support Phase 3 trials in sub-Saharan Africa of its islatravir nucleoside reverse transcriptase translocation inhibitor (NRTTI) as a once-monthly oral pre-exposure prophylaxis (PrEP) in women and adolescent girls at high risk for acquiring HIV-1. Enrollment could start as early as 2021, with Merck carrying out its own parallel trials in the…

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An injection every two months of ViiV’s cabotegravir is 89% more effective than daily Truvada (emtricitabine/tenofovir disoproxil fumarate) in preventing HIV acquisition in women, according to interim Phase 3 results from a study of the pre-exposure prophylaxis (PrEP) shot in sub-Saharan Africa, a ViiV press release said Monday.

Following recommendations from an independent monitoring board, the GSK subsidiary said it would halt the blinded, randomized portion of the 3,200-participant…

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GSK subsidiary ViiV has snagged a second approval for its monthly injectable two-drug HIV regimen containing ViiV’s cabotegravir and J&J’s rilpivirine, the company announced last week.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval in its October meeting, joining Health Canada, which issued a nod in March.

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Both Teva and GSK subsidiary ViiV targeted Gilead’s blockbuster HIV drug Truvada in recent days.

First, Teva launched two generics: the first U.S. generic version of Truvada as a pre-exposure prophylaxis (PrEP) therapy and treatment (when used with other HIV-1 medicines), and a version of Gilead’s 3-in-1 HIV combo, Atripla. According to the press release, the products will list at $48.51 and $78.86 per tablet, respectively, compared with Gilead’s average retail prices of $73.45 and $…

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