What advice would you give to people suffering from TB? If you are suffering from TB, receiving treatment may not only save your life but will also prevent you passing the disease on to your friends and loved ones. Remember, TB drugs are available and TB is curable. If you have drug-sensitive TB, the treatment takes six months and side effects are rare. The treatment for drug-resistant TB is longer around two years and results in more side effects, but these are manageable.
I know that the treatment is difficult and that it can be hard to stick to it, but the end result is worth it. If you think you might have symptoms of TB, visit a doctor as soon as possible.
And please, never give up. You too can beat TB. Find out more about TB and how it can be cured. Feature story 05 August TB in Uzbekistan: "The regimen is long and arduous". Ukraine Uzbekistan. The FDA initially declined to approve Cabenuva in because of concerns related to chemistry, manufacturing and controls, but not safety.
The injectable regimen was found to be as effective in maintaining viral suppression as continuing an oral three-drug regimen. Additionally, nine of 10 patients preferred Cabenuva over daily oral therapy. The most common adverse reactions in both studies were pyrexia, fatigue, injection site reactions, headache, nausea, musculoskeletal pain, sleep disorders, rash and dizziness.
In November, the FDA designated long-acting cabotegravir a breakthrough therapy for HIV PrEP after data from several studies showed it was effective at preventing infection among transgender women, men who have sex with men and cisgender women.
This new treatment option will be celebrated by a subset of people with HIV who struggle with taking daily pills — for whatever reason — and who have the ability to successfully come to clinic for monthly injections. Although the efficacy and safety of Cabenuva has been proven in clinical trials, the implementation devil is in the yet-to-be-sorted out details, especially for large, understaffed clinics that now also have to deal with COVID Many people will require transportation and reminders to ensure visits within the treatment window, and this adds to complexity and cost.
Bimonthly injections could also drop the annual cost substantially if the dose price remains the same. Long-acting therapies of many types are definitely the future, and a small piece of that future is finally with us now. By Eamon N. Perspective from Melanie A.
Thompson, MD. Patient preference data was collected from clinical trial participants who received Cabenuva. The results were descriptive in nature and are not intended to imply clinical significance. Not only is it the first, complete long-acting regimen, which allows for a dramatic reduction in the frequency of dosing, but it also was preferred by most clinical trial participants when compared to their prior daily oral regimens.
The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV. Interim findings presented at AIDS demonstrated that at four months, the majority of clinical staff participants continued to perceive the implementation of Cabenuva as highly acceptable, feasible and appropriate for PLHIV, and clinical staff had a substantial decrease in what they thought would be barriers to implementation of the injectable regimen.
For years, many of our clients have struggled to manage their health while working to stabilize key aspects of their lives. Cabenuva will provide some people living with HIV greater freedom to pursue vocational, educational and other opportunities, like travel, without the need for daily oral medication management.
A long-acting regimen is an innovation we have been waiting for. Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults 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.
Cabenuva is administered as two intramuscular injections cabotegravir and rilpivirine in the buttocks during the same visit at a specialist clinic by a healthcare professional. 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. ATLAS NCT is a phase III, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of long-acting, injectable cabotegravir and rilpivirine dosed every four weeks compared to continuation of current oral ARV of two nucleoside reverse transcriptase inhibitors NRTIs plus an integrase inhibitor INI , NNRTI, or protease inhibitor PI among virally suppressed individuals.
Subjects were required to be virally suppressed for six months or greater, on first or second regimen, with no prior failure. Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 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 resistance to either cabotegravir or rilpivirine.
Please see full Prescribing Information. The most common adverse reactions Grades 1 to 4 observed in at least 3 subjects receiving Vocabria were headache, nausea, abnormal dreams, anxiety, and insomnia. Shionogi joined in October For more information on the company, its management, portfolio, pipeline and commitment, please visit www. ViiV Connect provides one-on-one support from dedicated access coordinators, as well as having an integrated website, one site with many resources, including a portal.
For more information on ViiV Connect, visit www. GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
For further information please visit www. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected.
Such factors include, but are not limited to, those described under Item 3. Cabenuva cabotegravir, rilpivirine Prescribing Information.
US Approval January New England Journal of Medicine, 12 , —
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