Maggiolo, Franco
Gulminetti, Roberto
Pagnucco, Layla
Digaetano, Margherita
Cervo, Adriana
Valenti, Daniela
Callegaro, Annapaola
Mussini, Cristina
Article History
Received: 24 May 2022
Accepted: 4 October 2022
First Online: 12 October 2022
Declarations
:
: FM has served as a consultant on advisory boards for Abbvie, Bristol-Myers Squibb, Gilead, Janssen and ViiV; he has received lecture fees from Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Merck Sharp and Dome, and has received research and educational grants from Abbvie, Bristol-Myers Squibb, Gilead, GlaxoSmithKline and Janssen-Cilag.
: RG has served as consultant on advisory boards for Abbvie, Bristol-Myers Squibb, ViiV Healthcare and received lecture fees from Bristol-Myers Squibb, Janssen-Cilag, Roche, ViiV Healthcare, Merck Sharp and Dome.
: CM has served as a consultant on advisory boards for Abbvie, Bristol-Myers Squibb, Gilead, ViiV, Janssen, she has received lecture fees from Bristol-Myers Squibb, Gilead,ViiV, Merck Sharp and Dome, and has received research and educational grants from Gilead and ViiV. Other authors: no conflict.
: No experimental procedure (e.g. randomization) was applied, and drugs were used according to a considered alternative option in Italian Guidelines. In all patients, the decision to switch therapy was taken on clinical grounds as they presented a clinically relevant reason, either because of concomitant diseases, altered laboratory tests, drug adverse events or risk of drug-to-drug interactions. The drug combination was presented as a possible alternative and discussed individually according to clinical needs. The possibility to use the dual combination was discussed according to available data and to results obtained with similar dual therapies. Alternatives were presented according to the specific clinical situation. The choice of the dual regimen was therefore a part of the patient/doctor relationship during normal clinical practice. Although patients were followed prospectively, none of them switched therapy after the decision to perform this analysis, consequently the local EC ruled out that no formal ethics approval was required and patients gave their informed consent solely for the use of clinical and laboratory data.
: Not Applicable.