Dovato (dolutegravir + lamivudine)
3 July 2019. Related: ARVs, Fixed dose combinations, Integrase inhibitors, Nukes.
Dovato is a white tablet embossed with “SV137”. (Source: aidsinfo.nih)
Dovato was approved in the US in April 2019 and in Europe in July 2019.
- Dovato is a two-drug Fixed Dose Combination (FDC) containing 50 mg dolutegravir plus 300 mg lamivudine (3TC)
- It is approved in the US for people who are using HIV treatment for the first time and who do not have resistance to either dolutegravir or lamivudine.
- Dovato can be taken with or without food.
- Side effects are similar to the individual drugs – see dolutegravir and lamivudine. This is mainly mood changes and sleep disturbance links to dolutegravir.
- Dolutegravir seems to have fewer side efffects than most other HIV drugs. However, since approval there have been more reports of CNS side effects (similar to efavirenz). These include anxiety, mood changes and difficulty sleeping in less than 1 in 20 (5%) people. If you still get these side effects and you are taking meds in the morning, then it might be better to change to a different drug.
- Since approval, several studies have reported that integrase inhibitors, including dolutegravir, are linked with unexplained weight gain.
- Dovato should not be used by HIV positive people who also need treatment for hepatitis B.
- There is currently a caution against women using dolutegravir/lamivudine either when conceiving a baby or during the first four weeks of pregnancy. US prescribing information recommends pregnancy testing before starting dolutegravir/lamivudine.
- Drug interactions: There is a caution for interactions with some supplements (containing calcium, magnesium or aluminium), antacids and multivitamins. This also includes antacids that include magnesium or aluminium.
This requires separating the dolutegravir dose. These products need to be taken a minimum of two hours after dolutegravir or six hours before. Another important interaction is that dolutegravir doubles levels of metformin, and requires careful monitoring.
- There is a drug interaction between dolutegravir/lamivudine and carbamazepine or rifampin. If coadministered with carbamazepine or rifampin, take one tablet of Dovato once daily, followed by an additional dolutegravir 50-mg tablet, approximately 12 hours from the dose of Dovato.
- Dolutegravir/lamivudine is manufactured by ViiV Healthcare with the brand name Dovato.
- For full details please see the full prescribing information.
The European patient leaflet and detailed Product Information for dolutegravir is online at this link at the European Medicines Agency (EMA). Direct link to the PDF format.
The Patient Information is a simplified summary: what the drug is, why it is used, results from studies and cautions including side effects.
The Product Information is a detailed technical summary that you can access as a PDF file by clicking the ‘Product Information’ tab. It describes more precisely how the drug works and how it is processed by your body. This includes, for example, reported food interaction studies in terms of calories or fat content. It includes more details of the study results and a full list of side effects and drug interactions.