On 22 January 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Dutrebis, 150 mg lamivudine/300 mg raltegravir, film-coated tablet intended for the treatment of human immunodeficiency virus (HIV 1) infection in adults, adolescents, and children.
26 January 2015 | Street Insider
In general, the integrase ihibitors raltegravir and dolutegravir have potent anti-HIV activity and have relatively few interactions with other drugs. However in clinical trials of raltegravir, strains of HIV that can resist raltegravir have emerged in up to 60% of heavily treatment-experienced people, and up to 8% of participants who have never taken HIV drugs before. A study in France of patients who had virologial failure to HIV therapy while taking raltegravir has found that 61% had HIV that was still susceptible to all integrase inhibitors. In cases where HIV was resistant to raltegravir, 14% were also resistant to dolutegravir.
21 January 2015 | CATIE
The new anti-HIV integrase inhibitor dolutegravir is a highly potent drug. Alain Lafeuillade, a clinical researcher for 20 years in HIV disease, observed that Dolutegravir is highly effective alone in patients without integrase resistance. "Plasma viral load remained undetectable in my patients, and proviral HIV DNA in cells remained stable with only 50 mg 2 to 3 times a week," he said. He is proposing a low-dose dolutegravir monotherapy trial.
21 January 2015 | MMD Newswire
The NHS is to delay the introduction of a highly expensive drug that can save the lives of people infected with the hepatitis C virus. The move by NHS England is unprecedented, because the NHS rationing body, Nice (the National Institute for Health and Care Excellence) has approved the drug. Nice says sofosbuvir is cost-effective, because it is a cure for people who would otherwise run up huge NHS bills.
16 January 2015 | The Guardian
Johnson & Johnson unit Janssen has launched its once-daily, fixed-dose HIV combination therapy Rezolsta in the UK.
Rezolsta combines the company’s big-selling HIV therapy Prezista (darunavir) and Gilead Science’s Tybost (cobicistat).
15 January 2015 | Pharma Times
The treatment, AGS-004, is a personalized immunotherapy designed to train patients' T cells to better attack HIV. In a placebo-controlled Phase IIb trial, AGS-004 missed its primary endpoint of significantly lowering viral load among chronically infected patients.
12 January 2015 | FierceBiotech
Janssen R&D Ireland and Gilead Sciences have expanded two existing HIV drug collaborations through agreements to develop new once-daily HIV tablets, the companies said today in separate announcements. The value of both collaborations was not disclosed.
30 December 2014 | Genetic Engineering & Biotechnology News
On Monday, Gilead Sciences announced an expanded agreement with Johnson & Johnson to develop two different of cocktail pills to treat HIV. One drug will combine Gilead's tenofovir alafenamide, commonly called TAF, and Emtriva with Johnson & Johnson's Edurant. The other combines Gilead's TAF, Emtriva, and Tybost, along with Janssen's Prezista.
30 December 2014 | Motley Fool
Janssen-Cilag International NV (Janssen) today announced that the European Commission (EC) has approved the use of REZOLSTA ® (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus - 1 (HIV - 1) infection in adults aged 18 years or older. "REZOLSTA ® eliminates the need to take a boosting agent in a separate tablet with once - daily darunavir, reducing the pill burden for patients," said Christiane Moecklinghoff, M.D Ph.D, Medical Director, Virology, Janssen EMEA.
25 November 2014 | Janssen
HIV treatment remains far from perfect, and there are still seats at the table available for improved antiretrovirals. At IDWeek 2014 in Philadelphia, Paul Sax, M.D., made the case for this new generation of drugs, and provided an update on several of the most noteworthy candidates currently in development.
17 November 2014 | The Body Pro