Janssen to discontinue HIV vaccine Phase 3 trial.
Janssen Pharmaceuticals and Global Partners announced their intention to discontinue the Phase 3 Mosaico study of the HIV vaccine. The Phase 3 trial did not demonstrate vaccine efficacy in preventing HIV infection versus placebo.
Jannsen announced it is yet to notify the participants; participants who contracted HIV received HIV treatment.
Janssen completed the vaccinations in October 2022. Nearly 3,900 cisgender men and transgender people vulnerable to HIV infection were recruited in 50 sites.
Viiv's Apretude approved in the US for HIV prevention
ViiV, an HIV-specialized company owned by GSK, Pfizer, and Shionogi, announced that the US FDA approved Apretude (cabotegravir extended-release injectable suspension) as a pre-exposure prophylaxis (PrEP) option to prevent sexually acquired HIV.
Apretude is indicated for patients who are at least 35 kg and are HIV-negative before initiating the therapy.
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The approval is based on two Phase IIb/III active-controlled studies (HPTN 083 and HPTN 084), which evaluated the efficacy of Apretude in men and cisgender women who are at risk of acquiring HIV. In HPTN 083, the incidence of HIV infection decreased by 69% vs. FTC/TDF tablets; in HPTN 084 study, the incidence was reduced by 90% compared to FTC/TDF tablets.
ViiV healthcare’s Vocabria received approval in Europe for HIV infection
ViiV Healthcare announced that the European Commission approved Vocabria (cabotegravir injection and tablets) in combination with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets) for HIV treatment. The drug is approved for the treatment of HIV-1 infection in adults who are virologically suppressed.
The approval is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) ATLAS-2M studies.
Among the trials, 55% of patients preferred not to take medication every day, 58% of patients said that taking medication every day reminds them of being HIV infected, 38% of patients reported anxiety while taking medicine every day.
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Vocabria reduces the days on which the drug is administered from 365 days to 12 or 6 times per year. Vocabria is the first long-acting injection, avoiding taking daily oral tablets following the initiation phase.
Cabotegravir is an integrase strand transfer inhibitor, prevents the integration of viral DNA with the host genetic material. This step is essential for the replication of the virus.