Treatment-naïve patients in the UK can now get access to Johnson & Johnson unit Tibotec Pharmaceutical’s HIV drug Prezista, after regulators expanded the drug’s approved uses.

Specifically, patients who have not received prior HIV therapy can now take Prezista (darunavir) 800mg with a low-dose ritonavir as part of combination therapy, offering healthcare professionals an additional option for managing the disease.

Therapy for treatment-naïve patients consists of two 400mg Prezista pills taken in a once-daily regimen, thereby offering patients greater convenience, the company says, which should in turn help to encourage better adherence and boost treatment outcomes.

In addition, Tibotec has launched a new 600mg tablet for treatment-experienced patients with HIV, which replaces the 300mg tablet and reduced the pill burden from four a day to two.

Prezista was first launched for highly treatment-experienced adults with HIV in February 2007, and subsequently won two additional marketing authorisations within two years to expand its licence to treatment-experienced adults in November 2008 and treatment-naive adults earlier this year.

“The relatively short approval timeline since Prezista's original launch demonstrates the European Commission’s confidence in [the drug’s] safety and efficacy in all adults with HIV,” a company spokesperson told PharmaTimes UK News.

Comparable price, better efficacy
In addition, the spokesperson said pricing for the treatment-naïve dose of Prezista is comparable to Abbott’s rival drug Kaletra (lopinavir) plus ritonavir, but stressed that the Prezista/ritonavir combination provides the “added benefit of superiority” over the Kaletra-based regimen, as demonstrated by findings of the ARTEMIS trial. At 96 weeks in the study, significantly more patients in the darunavir/r arm reached an undetectable viral load (<50 copies/mL) versus those taking the lopinavir/r combination.

“We welcome Prezista’s availability as an effective, once-daily option for adults who have never taken HIV medication before,” commented Mark Nelson, Consultant Physician and Deputy Director of HIV Research at Chelsea and Westminster Hospital, London, UK. “It has made a significant contribution in the care of treatment-experienced adults with HIV for the last two years, and this is an important treatment development for patients,” he added.