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RUKOBIA (fostemsavir)

Opinions on drugs - Posted on Jun 18 2021

Reason for request

First assessment

Key points

Favourable opinion for reimbursement in the treatment of adults with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

The management of HIV infection is well standardised and is the subject of national and international guidelines. The treatment combinations recommended as first-line therapy include triple therapy with three highly active agents combining two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent (one protease inhibitor [PI], one non-nucleoside reverse transcriptase inhibitor [NNRTI] or one integrase inhibitor [INI]) or dual therapy with dolutegravir + lamivudine (DOVATO).

In patients with established virologic failure, the choice of the new treatment should ideally be discussed at a multidisciplinary team meeting, including clinicians, a virologist and a pharmacologist. The opinion of a team experienced in the management of these patients is essential in situations where the treatment options appear to be limited. Except in specific cases, treatment interruptions should be avoided. The optimal treatment regimen consists of three active agents, based on treatment history and cumulative genotype. ARVs that can be considered to be active are those belonging to a class not yet used or belonging to a class already used but for which the current or cumulative resistance genotype(s) suggest(s) that the ARV in question is active.

Introduction of a new therapy including just one active medicinal product is not recommended since this would lead to rapid selection of new resistance mutations. Following a change of antiretroviral therapy due to virologic failure, early control (after one month) of viral load (VL) and the safety of the new treatment is required.

Role of the medicinal product in the care pathway

RUKOBIA (fostemsavir) is a last-resort option, in combination with other appropriate antiretrovirals, for the treatment of patients with multidrug-resistant HIV-1 infection and for whom currently available antiretroviral therapies are unable to achieve viral suppression.

Other treatments with a last-resort MA like RUKOBIA (fostemsavir) include the medicinal product TROGARZO (ibalizumab), recently assessed by the Committee. The latter is administered by the IV route, in contrast with RUKOBIA (fostemsavir), which has the advantage of being administered orally. In certain cases, these two medicinal products have been used in combination in clinical studies (TMB-301 [42.5% of patients] and BRIGHTE [cohort B: 15% of patients]).

Special recommendations

Given the product characteristics and the complexity of management of patients in a multidrug failure situation, the Committee recommends restricting the prescription of RUKOBIA (fostemsavir) to physicians experienced in the management of patients with multidrug-resistant HIV-1 infection and following a documented proposal resulting from discussion at a multidisciplinary team meeting.



Clinical Benefit


The Committee deems that the clinical benefit of RUKOBIA (fostemsavir) is substantial in the MA indication.

Clinical Added Value



  • its antiviral activity against HIV-1 infection resistant to the antiretroviral medicines currently approved,
  • limited clinical data (BRIGHTE study) available in patients in a multidrug-resistant (multi-failure) situation having demonstrated a marked early virologic activity over a period of 8 days during functional monotherapy, with a reduction of viral load (VL) versus placebo of -0.625 log10 copies/mL (i.e., a 4.22-fold division of the VL in one week),
  • maintenance of this effect until at least week 96, thereby enabling 60% of patients to have an undetectable viral load after this time,
  • long-term follow-up data from this study (up to 96 weeks), which is reassuring in terms of immune response and safety of fostemsavir in combination with optimised background therapy (OBT),
  • the substantial medical need to have access to alternatives for patients in whom all the treatment options have been exhausted,

the Transparency Committee considers that RUKOBIA (fostemsavir), in combination with optimised background therapy, provides a moderate clinical added value (CAV III) in the therapeutic strategy in patients infected with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.


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