Abacavir

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

Assessment report

Assessment report for Triumeq (dolutegravir/abacavir/lamivudine), ViiV Healthcare UK Limited, 26 June 2014, EMA/580654/2014.

Hazard

Persistence: "OECD 301B: DOC = 27 % Primary degradation = 41–94 %. Not ready biodegradable." OECD 308: Not submitted.

Bioaccumulation: Log D_ow = 1.20.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Ceriodaphnia dubia) NOEC 4 800 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC = 3.0 microgram/L.

PNEC = Lowest NOEC, 4 800 microg/L/100 (Assessment Factor (AF) for 1 chronic study) = 48 microg/L

PEC/PNEC = 0.0625 which gives the risk insignificant.

"Dolutegravir, abacavir or lamivudine are not PBT substances. Updated Environmental Risk Assessments were provided for acabavir and lamivudine. Dolutegravir is not expected to pose a risk to the environment. The available data do not allow concluding definitively on the potential risk of abacavir or lamivudine to the environment. Additional studies are required, please refer to section 2.3.5. The Applicant will submit the final reports two years following approval." No such information has been found on the EMA's website (2021-10-27).

Fass environmental information

Fass environmental information for Kivexa (abacavir, lamivudine) from GlaxoSmithKline (downloaded 2021-10-27).

Hazard

Persistence: "Abacavir is not readily biodegradable nor inherently biodegradable. The phrase “Abacavir is potentially persistent” is thus chosen."

Bioaccumulation: "Log D_ow = 1.20 at pH 7 (OECD 107)."

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Ceriodaphnia dubia) NOEC 5 600 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2019. PEC/PNEC = 1.88 x 10^-4 wich gives the risk insignificant.