NHS England will release crucial funding for HIV therapy Rezolsta, its once-daily, fixed-dose combination of darunavir and the ‘pharmacoenhancer’ cobicistat.
The drug is indicated for use in combination with other antiretroviral medications for treating adults with human immunodeficiency virus-1 (HIV-1) whose virus does not carry darunavir resistance-associated mutations.
This decision means that, across England, clinicians will be able to routinely prescribe darunavir - the UK's most prescribed protease inhibitor - combined with a ‘booster’ in a single pill to adults living with HIV-1.
“By funding treatment, NHS England is making available a treatment option for individuals who require darunavir to effectively control the HIV, but who would potentially also benefit from the convenience of fewer tablets to support their adherence to treatment,” noted Rozlyn Bekker, medical director of Janssen UK.
Less than two out of three HIV patients in the UK currently reporting 100 percent adherence after eight months of treatment, and experts believe that the fixed-dose combination of darunavir/cobicistat could help improve adherence by reducing the number of pills that a patient needs to take, the firm noted. “This is important given that optimal adherence is generally considered to be above 95 percent, the level required to prevent HIV becoming resistant to medication”, it said.
Clinical data show that once-daily darunavir/cobicistat, in combination with two nucleotide/nucleoside reverse transcriptase inhibitors, offers effective virological suppression, with virologic response rates over 48 weeks of 81 percent overall and 83 percent in treatment-naïve patients, the firm noted.
Also, just 5 percent of patients discontinued treatment due to adverse events, the most common of which were diarrhoea (27 percent) and nausea (23 percent), which were grade one or two in severity.