Long-acting HIV-1 treatment may remove need for daily therapy
ViiV Healthcare has received Marketing Authorisation for the first complete long-acting injectable HIV treatment in Europe.
Marketing Authorisation has been granted by the European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets).
The long-acting injectable regimen was preferred by the majority of clinical trial patients who tried the treatment over their previous daily oral therapy.
ViiV Healthcare, owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, announced the authorisation of the new treatment in the European Union (EU), for the treatment of HIV-1 infection in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the EU, for the treatment of HIV-1 infection in
What is Tivicay used for?
Tivicay (and Tivicay PD for children) is a medication in the class of drugs called “integrase strand transfer inhibitors” (INSTIs), which stop HIV from making copies of itself later in its life cycle. Tivicay is used for the treatment of HIV in combination with one or more other drugs. It was approved by the U.S. Food and Drug Administration in 2013. In 2020, the FDA approved Tivicay PD for use in children at least 4 weeks old and weighing at least 6.6 pounds (3 kg). The generic name for Tivicay is dolutegravir.
How often is Tivicay taken?
Tivicay is normally taken at the same time every day. Some adults who are also taking certain other medications that affect Tivicay levels in the body (including some antacids and laxatives) may need to take it twice daily. Always follow your medical provider’s instructions for how and when to take Tivicay.
GSK: ViiV Healthcare Gets FDA Approval For HIV Treatment Cabenuva
LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) said Friday that its majority-owned specialist HIV company ViiV Healthcare has received approval from the US Food and Drug Administration for Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.
Cabenuva is provided as a co-pack with two injectable medicines - ViiV Healthcare s cabotegravir and Janssen s rilpivirine - dosed once monthly, as an option to replace the current antiretroviral or ARV regimen.
The treatment is taken in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
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TITUSVILLE, N.J., Jan. 21, 2021 /PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen s rilpivirine and ViiV Healthcare s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resist
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Cabenuva allows virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine to maintain viral suppression with 12 dosing days per year
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ( GSK ), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines ViiV Healthcare s cabotegravir and Janssen s rilpivirine
- dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiati