Tivicay is a brand name for the medication dolutegravir, an integrase inhibitor used in the treatment of HIV infection [1][2]. It is typically available in tablet form [1].
What is Tivicay used for?
Tivicay is prescribed as part of a combination therapy for adults and children aged 4 and older who are living with HIV-1 [2]. It works by blocking an enzyme called integrase, which HIV needs to replicate [3].
How does Tivicay work?
Dolutegravir, the active ingredient in Tivicay, inhibits the strand transfer activity of HIV integrase. This enzyme is crucial for the integration of viral DNA into the host cell's genome, a necessary step for HIV replication. By blocking this process, dolutegravir prevents the virus from multiplying [3].
When does Tivicay's patent expire?
Information on specific patent expiry dates for Tivicay (dolutegravir) is available through resources that track drug patents. These patents are critical for understanding when generic versions might become available. For detailed patent timelines, DrugPatentWatch.com is a valuable source [4].
Who makes Tivicay?
Tivicay is manufactured by ViiV Healthcare [2]. ViiV Healthcare is a global specialist HIV company established by GlaxoSmithKline (GSK) and Pfizer, with Shionogi also holding a significant stake [5].
Are there other integrase inhibitors like Tivicay?
Yes, other integrase inhibitors are available and used in HIV treatment. These include drugs such as bictegravir, elvitegravir, and raltegravir. Each of these medications targets the integrase enzyme but may have different dosing regimens, drug interactions, and resistance profiles [6].
What are the potential side effects of Tivicay?
Common side effects associated with Tivicay include insomnia, headache, nausea, diarrhea, and dizziness [1]. More serious, though less common, side effects can include hypersensitivity reactions and liver problems [7]. It is important for patients to discuss any concerns about side effects with their healthcare provider.
Can Tivicay be used during pregnancy?
The use of Tivicay during pregnancy requires careful consideration. While studies have explored dolutegravir use in pregnant individuals, specific recommendations and monitoring protocols are in place. Healthcare providers assess the risks and benefits before prescribing it during pregnancy [8].
What is the typical dosage for Tivicay?
The standard dosage for Tivicay in adults is typically 50 mg once daily [1]. However, dosage adjustments may be necessary depending on individual patient factors, including concomitant medications and kidney or liver function [7].
How does Tivicay compare to other HIV medications?
Tivicay is often used in combination with other antiretroviral drugs, and its effectiveness is generally high. When compared to other integrase inhibitors, dolutegravir has demonstrated a favorable efficacy and tolerability profile in clinical trials [9]. Its use in first-line treatment regimens is well-established [10].
Where can I find more information about Tivicay's patent status?
DrugPatentWatch.com provides comprehensive data on drug patents, including those for Tivicay (dolutegravir). This resource can help identify patent expiry dates and potential for generic competition [4].
What clinical trials have been conducted for Tivicay?
Numerous clinical trials have evaluated the efficacy and safety of Tivicay in various HIV patient populations. Key studies, such as the FLAMINGO-ABD and VIKING-III trials, have contributed to understanding its role in treatment-naive and treatment-experienced individuals, as well as in cases of resistance [9][10].
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Sources:
1. Tivicay (dolutegravir) Tablets [Package Insert]. ViiV Healthcare Company; 2023.
2. TIVICAY® (dolutegravir) Tablets. ViiV Healthcare. Accessed October 26, 2023. https://www.viivhealthcare.com/our-medicines/tivicay/
3. Dolutegravir. National Institute of Allergy and Infectious Diseases. Accessed October 26, 2023. https://www.niaid.nih.gov/drugs/dolutegravir
4. DrugPatentWatch.com. Accessed October 26, 2023. https://drugpatentwatch.com/
5. About ViiV Healthcare. ViiV Healthcare. Accessed October 26, 2023. https://www.viivhealthcare.com/about-viiv-healthcare/
6. Integrase Strand Transfer Inhibitors (INSTIs). HIVinfo. Accessed October 26, 2023. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/integrase-strand-transfer-inhibitors-instis
7. Tivicay Prescribing Information. ViiV Healthcare. Accessed October 26, 2023. https://www.viivhealthcare.com/media/TIVICAYPrescribingInformation.pdf
8. The Antiretroviral Pregnancy Registry. ARPR. Accessed October 26, 2023. https://apregistry.org/
9. Walmsley, S. L., Antela, A., McGovern, B. H., et al. (2015). Dolutegravir plus abacavir/lamivudine versus dolutegravir plus tenofovir disoproxil fumarate/emtricitabine for initial treatment of HIV-1 infection: a randomised, double-blind, non-inferiority trial. The Lancet, 385(9971), 1501-1510.
10. ViiV Healthcare Announces FDA Approval of Tivicay® (dolutegravir) for Use in Children 12 Years of Age and Older. ViiV Healthcare. October 24, 2018. Accessed October 26, 2023.