BERLIN, Oct 21 (APM) - German prescribing guide Arzneitelegramm said the benefits of Bristol-Myers Squibb's Daklinza (daclatasvir) in combination with Gilead's Sovaldi (sofosbuvir) in hepatitis C (HCV) still had to be proven via further studies before the combination could be used "on a wider basis".
"The benefits for several patient groups, for whom the therapy has been approved, were not tested in the (existing) studies at all," the pharma-critical Arzneitelegramm said in an issue made available on Monday.
Daklinza is approved in HCV genotypes 1, 2, 3 and 4, though with different treatment regimens-
Although, the Daklinza/Sovaldi combination showed a virological response rate of 100% in both treatment-naïve and previously-treated patients without cirrhosis, the prescribing guide said it had been tested on "alarmingly few" patients.
Although, the Daklinza/Sovaldi combination showed a virological response rate of 100% in both treatment-naïve and previously-treated patients without cirrhosis, the prescribing guide said it had been tested on "alarmingly few" patients.
"In view of rapidly changing hepatitis C therapy, and the lack of extensive comparative studies, it is increasingly difficult to express well-founded recommendations. We judge daclatasvir as reserve medication for genotype 1."
Although the guide did not say what should take precedence over Daklinza, the drug is the third direct-acting antiviral (DAA) authorised in Europe, after Sovaldi in January (APMMA 36948) and Janssen/Medivir's Olysio in May. (APMMA 38408) (APMMA 39516)
The Arzneitelegramm said it found no value in GlaxoSmithKline's Anoro (umeclidinium+vilanterol), the follow-on chronic obstructive pulmonary disease (COPD) inhaler to Seretide/Advair (fluticasone+salmeterol).
The prescribing guide wrote: "Clinically relevant advantages over (Boehringer Ingelheim's) Spiriva (tiotropium) in terms of improved lung function and quality of life do not seem sufficiently proven. A lowered exacerbation rate is not certain, unlike with tiotropium.”
Anoro was tested against Spiriva in three randomised trials, with the simultaneous use of inhaled glucocorticoids being allowed. The primary endpoint-a clinically relevant difference of at least 100 ml in forced expiratory volume in one second (FEV1)-was reached with Anoro in only one of the studies, which is yet to be published, said the Arzneitelegramm.
While Anoro showed it reduced the risk of exacerbation compared to Spiriva, none of the three studies were set up to show the effects of exacerbations, the guide added.
Advantages in terms of tolerability were not proven - although long-term safety, especially with regards to cardiovascular and cerebrovascular side effects are being assessed in a post-marketing observational study, according to the Arzneitelegramm.
The Arzneitelegramm's opinion mirrors that of health technology assessment institute IQWiG, which found no added benefit for Anoro in COPD. (APMMA 40091)
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