HIV Treatment Revolution: From 365 Days to Just 6! EU Approves GSK/Janssen Vocabria/Rekambys with No Oral Lead-In Required
Oct 29, 2021 03:10
CST Updated
03:10
ViiV Healthcare
AIDS Drug Developer
Janssen Pharmaceuticals
Pharmaceutical R&D Developer
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Shionogi
Pharmaceutical R&D and Manufacturer
Pfizer
Pharmaceutical R&D Developer
GSK
Pharmaceutical R&D Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
October 28, 2021 /BioonBIOON/ --ViiV Healthcare is a company established byGlaxoSmithKline(GSK) Holding,Pfizer(Pfizer) and Shionogi-held HIV/AIDS drug research and development company. Recently, the company announced that the European Commission (EC) has approved updates to the Summary of Product Characteristics (SmPC) for Vocabria (cabotegravir injection and tablets) and Rekambys (long-acting rilpivirine injection) from Janssen Pharmaceuticals, a Johnson & Johnson subsidiary,Provides healthcare professionals and people living with HIV with the option to directly initiate injectable therapy without the need for oral lead-in therapy with cabotegravir and rilpivirine.. Oral cabotegravir and rilpivirine may be administered for one month to assess drug tolerability, which is an optional regimen in the updated SmPC. Data indicate that,The two initial routes of administration have similar safety and efficacy.
cabotegravir/rilpivirine (CAB/RPV), co-developed by ViiV Healthcare and Janssen Pharmaceuticals, a Johnson & Johnson company, is the first complete long-acting regimen for the treatment of HIV-1 infection in adults. Among them,Cabotegravir is a long-acting HIV-1 integrase strand transfer inhibitor, and rilpivirine is a long-acting non-nucleoside reverse transcriptase inhibitor.
In the European Union, the long-acting CAB/RPV regimen was approved in December 2020: Vocabria (cabotegravir injection and tablets) in combination with Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets) for HIV-1-infected adults who are virologically suppressed on a stable ARV regimen.In the European Union, this long-acting therapy (cabotegravir injection + rilpivirine injection) can be administered via injection once monthly or once every two months.
In the United States, Cabenuva was approved in January 2021 for once-monthly administration (only 12 injections per year). It is indicated for the treatment of adults with HIV-1 infection to replace their current antiretroviral (ARV) regimen, in those who have achieved virologic suppression (HIV-1 RNA < 50 copies/mL) on a stable regimen, have no history of treatment failure, and have no known or suspected resistance to cabotegravir or rilpivirine. Cabenuva is supplied as a co-packaged combination of two injectable drugs: cabotegravir (CAB) from ViiV Healthcare and rilpivirine (RPV) from Johnson & Johnson.
It is particularly noteworthy that,The CAB/RPV long-acting regimen is the world's first complete, long-acting HIV treatment regimen, administered via intramuscular (IM) injection once monthly or once every two months.. The market approval of this drug marks a major milestone,This will revolutionize HIV treatment by transitioning from daily oral medication year-round to injections administered once a month or once every two months, requiring only 12 or 6 injections annually.
This EU approval decision is based on the 124-week results from the Phase 3 FLAIR clinical trial, and is supported by extensive safety and tolerability data from Phase 2 and Phase 3 studies of oral CAB/RPV prior to intramuscular injection. In these studies, no safety signals were identified that would necessitate the use of oral lead-in therapy. As the Phase 3 FLAIRClinical TrialAs part of an extension study investigating the administration of injectable CAB and RPV without an oral lead-in, the results demonstrated that when initiating CAB/RPV injectable therapy, no significant differences were observed in maintaining HIV suppression, safety, tolerability, and pharmacokinetics, regardless of whether an oral lead-in period was used.
Dr. Harmony P. Garges, Chief Medical Officer at ViiV Healthcare, stated: “The ability to initiate CAB/RPV injectable therapy without an oral lead-in will streamline the treatment initiation experience for healthcare professionals and people living with HIV, enabling them to start long-acting therapy more quickly. People living with HIV face a range of challenges with daily oral antiretroviral therapy, including daily pill reminders and the fear of HIV status disclosure. We are pleased with this decision, which now allows these patients to transition from their current oral regimens to long-acting injectable therapy without the need for an oral lead-in. At ViiV Healthcare, we are proud to provide innovative options that meet the evolving needs of people living with HIV.” (Bioon.com)