A new U.S. FDA approval adds adolescents to the population eligible for Cabenuva, the long-acting injectable HIV-1 treatment combining ViiV’s cabotegravir and Janssen’s rilpivirine, J&J announced Tuesday. Like adults, virologically suppressed adolescents age 12 and older can take the combo either monthly or every two months.
In related news, GSK subsidiary ViiV announced a Cabenuva label update last week. The FDA-approved update eliminates a mandatory oral lead-in with cabotegravir…
Unitaid will fund “two large-scale operational projects” distributing long-acting injectable HIV pre-exposure prophylaxis (PrEP) to at-risk populations in Brazil and South Africa, the WHO-hosted agency announced last week.
ViiV Healthcare—recently under fire for its reluctance to pursue voluntary licensing for the cabotegravir-based shots—will donate supplies. But the donation didn’t exempt the GSK subsidiary from pricing scrutiny from Unitaid’s executive director, who publicly urged…
The U.S. National Institute of Allergy and Infectious Diseases (NIAID) has dosed the first participant in a Phase 1 trial of a trio of mRNA-based vaccines against HIV, according to a press release Monday from the U.S. National Institutes of Health.
Manufactured by Moderna through a NIAID-backed contract, each of the three candidates in the mRNA-1574 vaccine program encodes for “different but highly related, stabilized proteins” of HIV, the press release said. The U.S.-based study seeks…
When ViiV Healthcare announced last week that it would not pursue a voluntary licensing deal for its long-acting HIV prevention shot, blowback was swift. Advocacy groups cried foul. STAT remarked on the “surprise move.” The company backpedaled within days, but its updated statement continued to indicate the GSK subsidiary would remain the sole supplier of long-acting cabotegravir, “at least during the initial years.”
The statement that triggered the furor was less obliging: “voluntary…
A consortium seeking to optimize existing cryptococcal meningitis therapy flucytosine has launched a South African Phase 1 trial to evaluate a new formulation of the antifungal, the Drugs for Neglected Diseases Initiative (DNDI) announced last week.
With funding from the European & Developing Countries Clinical Trials Partnership, DNDI and other members of the 5FC HIV-Crypto consortium will assess three sustained-release formulations that can be taken orally or via nasogastric tube…
Gilead last week offered new clinical data on the sustained efficacy of lenacapavir in heavily treatment-experienced people living with multidrug-resistant HIV. At 52 weeks, 83% of participants receiving the investigational, long-acting HIV-1 capsid inhibitor (in combination with an optimized background regimen) achieved an undetectable viral load, according to the California-based company's press release. Gilead presented the data at the 29th Conference on Retroviruses and Opportunistic…
Moderna and the International AIDS Vaccine Initiative (IAVI) have dosed the first participants in a Phase 1 trial of an experimental mRNA-based HIV vaccine (mRNA-1644) and boost candidate (mRNA-1644v2-Core), according to a joint press release issued last week.
The trial builds off a previous proof-of-concept study showing that a compound (developed by IAVI and Scripps Research) in mRNA-1644 generated a B-cell response in 97% of recipients. Both trials are part of a Gates Foundation-…
Gilead will pay rival ViiV $1.25 billion upfront and a 3% royalty on future U.S. sales (through 2027) of its once-daily single-tablet Biktarvy regimen—bictegravir, emtricitabine and tenofovir alafenamide—as part of a patent infringement settlement, ViiV’s parent company announced Monday.
The GSK subsidiary filed suit against Gilead in 2018, claiming that the bictegravir component of Biktarvy infringed on ViiV’s patents relating to its dolutegravir HIV drug and other compounds.
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Vir Biotechnology announced last week that the Gates Foundation is giving the San Francisco-based biotech $10 million in grant funding and a $40 million equity investment to back the development of platform technologies that can produce broadly neutralizing antibodies to treat HIV and prevent malaria.
The new initiative will trial the “potential impact of broadly neutralizing antibodies engineered to inhibit viral replication and spread in people infected with HIV, as well as their…
ViiV has won U.S. FDA approval for Apretude, the first long-acting injectable for pre-exposure prophylaxis of HIV, the GSK subsidiary announced Monday.
The cabotegravir-based shot can be administered as few as six times per year after the first two 600-mg doses, per the press release. In clinical trials, Apretude offered 69%-90% lower incidences of HIV when compared to daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets.
The FDA nod gives the injectable…