VOCABRIA oral tablets, to be used for short time periods in conjunction with CABENUVA, have also been approved by
CABENUVA allows virologically suppressed adults living with HIV to maintain viral suppression while reducing their dosing schedule from 365 days to 12 days per year. VOCABRIA and CABENUVA should not be used in patients with known or suspected resistance to cabotegravir or rilpivirine. A kit with two injectable medicines-
The approval of CABENUVA is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 participants from 16 countries.[1],[2] Prior to initiating treatment with CABENUVA, oral dosing of cabotegravir and rilpivirine lead-in was administered for approximately one month to assess the tolerability of cabotegravir and rilpivirine. The studies demonstrated that CABENUVA, when injected intramuscularly in the buttocks, once a month, was as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression throughout the 48-week study period.
In both studies, the most common adverse reactions (Grades 1 to 4) observed in 2% of participants receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash, and diarrhoea. Over the 48-week study period, a total of 4% of participants discontinued CABENUVA due to adverse events.[3]
CABENUVA was preferred over their previous daily oral therapy by approximately 9 out of 10 patients who switched to cabotegravir and rilpivirine long-acting in ATLAS and FLAIR studies. Treatment preference data was collected from ATLAS and FLAIR clinical trial participants who received CABENUVA. In a pooled exploratory analysis of this Intent-to-Treat Exposed (ITT-E) population, 532 participants completed a single-item question at Week 48 (59 participants did not) and 88% (523/591) preferred CABENUVA compared with 2% (9/591) who preferred their previous ARV treatment. The results were descriptive in nature and are not intended to infer clinical significance.[4]
Cabotegravir and rilpivirine complete long-acting regimen for the treatment of HIV-1 infection therapy is under review by the
About CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) and VOCABRIA (cabotegravir tablets)
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL). CABENUVA is administered intramuscularly as two individual injections in the buttocks once a month by a healthcare provider.
VOCABRIA is indicated, in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL) as an oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA and as an oral bridging therapy for missed CABENUVA injections.
VOCABRIA and CABENUVA should not be used in patients with known or suspected resistance to cabotegravir or rilpivirine.
The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by
INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
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About GSK
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