VEKLURY (remdésivir) - COVID-19

Key points

Approval of reimbursement subject to susceptibility of the SARS-CoV-2 strain to remdesivir, in recommended cohorts and for patients for whom PAXLOVID (nirmatrelvir/ritonavir) treatment is not optimal particularly on account of contraindications or resistance, in the following indication: “treatment of COVID-19 disease for adults and paediatric patients (weighing at least 40 kg), who do not require oxygen therapy and who are at an increased risk of progression to a severe form of COVID-19”.

Therapeutic improvement?

No therapeutic improvement in the care pathway.

Role in therapeutic strategy?

Given the current predominant circulation of Omicron BA.5 and its sublineages, in particular BQ.1.1 (94% of screened tests) in France resulting in updating of the national guidelines, the early curative treatment strategy aimed at preventing progression to a severe form in at-risk patients is based on (see DGS-Urgent No. 2022-86 of 22/12/2022):

• PAXLOVID (nirmatelvir/ritonavir), as a first-line approach, regardless of the SARS-CoV-2 variant or sublineage causing the infection, particularly from 65 years of age regardless of vaccination status and any comorbidities;
• in cases of contraindication to PAXLOVID (nirmatrelvir/ritonavir) particularly associated with drug interactions AND in the absence of any renal contraindication, VEKLURY (remdesivir), as a second-line approach on account of continued in vitro efficacy regardless of the variant.

Note that monoclonal antibodies are no longer recommended in the current epidemic context. However, in its opinion of 19 December 2022, COVARS stated that sotrovimab (XEVUDY) may be discussed in cases of contraindication to PAXLOVID (nirmatrelvir/ritonavir).

Role of the medicinal product

Despite the many clinical uncertainties around the efficacy of VEKLURY (remdesivir) in a context of very rapidly evolving therapeutic strategies, the role of VEKLURY (remdesivir) has been defined with regard to its potential utility for certain patients at a very high risk of progression to a severe form of COVID-19.

The Committee deems that VEKLURY (remdesivir) could represent a therapeutic option in the treatment of adult and paediatric patients (weighing at least 40 kg) who do not require oxygen therapy and who are at an increased risk of progression to a severe form of COVID-19 only in the case of SARS-CoV-2 strains susceptible to remdesivir, in recommended cohorts and for patients for whom PAXLOVID (nirmatrelvir/ritonavir) treatment is not optimal particularly on account of contraindications or resistance.

Additional data are needed and expected to establish, with a superior level of evidence. the efficacy, adverse effects and risks of VEKLURY (remdesivir) in the marketing authorisation indication.

Refer to the national guidelines in terms of the strategy of the use of preventive and curative COVID-19 treatments.

The Committee points out that limited data are available in kidney and liver failure patients, and in pregnant women.

Use of VEKLURY (remdesivir) must be accompanied by close clinical monitoring considering the possible adverse reactions at the time of injection (particularly arterial hypotension) and kidney function and liver function follow-up (information lacking in the context of the RMP).

Special recommendations

The Committee points out that use of anti-COVID-19 treatments does not exempt patients from adhering to control and social distancing measures within the framework of COVID-19 prevention, and that VEKLURY (remdesivir) is not intended to be used as a substitute for SARS-CoV-2 vaccination.

The Committee relays the request from patient associations around the need to facilitate access to COVID-19 treatment in community settings.

Due to the rapidly evolving epidemiological context, the Committee would like to see regular updates of the national guidelines in order to adapt the COVID-19 care strategy according to data on the susceptibility of the variants in circulation to the treatments available.