Drug updated on 4/24/2024
| Dosage Form | Tablet (oral; 10 mg, 25 mg, 50 mg); PD Tablet for suspension (oral; 5 mg) |
| Drug Class | HIV-1 integrase strand transfer inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Tivicay and Tivicay PD are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least 4 weeks and weighing at least 3 kg.
- Tivicay is indicated in combination with rilpivirine 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 for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
Summary
- Dolutegravir (Tivicay) is used in combination with other antiretroviral agents for treating HIV-1 infection in adults and pediatric patients, as well as a complete regimen for virologically suppressed adults.
- The information was derived from 21 systematic reviews/meta-analyses on Tivicay's safety and effectiveness compared to other antiretroviral agents.
- For pregnant women living with HIV, dolutegravir-based therapy does not present an increased risk of adverse perinatal outcomes compared to other ART classes, offering a safer alternative than Protease Inhibitor-based ART, which is associated with a risk of small gestational age outcomes.
- Dolutegravir-containing regimens have superior efficacy over non-dolutegravir containing regimens in achieving viral suppression at 48 to 96 weeks, especially beneficial for patients with high baseline viral loads (>100,000 copies/mL).
- Data shows reassuring safety and efficacy profiles for dolutegravir and Raltegravir use in children and adolescents, with minimal concerns regarding grade 3/4 adverse events or treatment discontinuations due to drug-related issues, making it the preferred regimen choice for this population group.
- Aging can affect the pharmacokinetics of ARVs; however, exposure to dolutegravir appears modestly increased or unaffected by age, suggesting that it could be a favorable option considering the higher likelihood of co-medications and comorbidities among older individuals living with HIV.
- Analysis of different Integrase Strand Transfer Inhibitors (INSTIs) indicates that dolutegravir may lead to more significant weight gain compared to others like Elvitegravir, suggesting a need for monitoring and management strategies for weight among recipients.
- In cases of virological failure on dolutegravir-based regimens, the most common resistance mutations were R263K and G118R, predominantly seen in INSTI-naive individuals, highlighting dolutegravir's high barrier to resistance as an essential factor for selection, especially for those experienced or with prior issues.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tivicay (dolutegravir) Prescribing Information. | 2022 | ViiV Healthcare, Research Triangle Park, NC |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| EACS Guidelines version 12.0. | 2023 | European AIDS Clinical Society |
| Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. | 2023 | NIH |
| Major revision version 12.0 of the European AIDS Clinical Society guidelines 2023. | 2023 | HIV Medicine |
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2022 | NIH |
| NYSDOH AIDS Institute HIV Clinical Guideline. | 2022 | New York State Department of Health AIDS Institute |
| European AIDS clinical society guidelines v10.1 October 2020. | 2020 | European AIDS Clinical Society |