Sovaldi scores in HIV patients
pharmafile | July 21, 2014 | News story | Sales and Marketing | Gilead, HIV, JAMA, hep C, hepatitis C, sovaldi
Patients with HIV and hepatitis C virus (HCV) have responded well to a combination of Gilead Sciences’ Sovaldi and ribavirin in a new study of 223 people.
The trial, reported in the Journal of the American Medical Association (JAMA), found that there was a 76% sustained viral response (SVR) in patients co-infected with HCV genotype 1 and HIV after 24 weeks of treatment.
This sort of impressive response is a major factor in why Sovaldi is expected to reach around $10 billion in sales by next year, and is on course to become the biggest selling medicine in the world.
Another reason for that figure is its eye-watering cost – £69,965 ($84,000) for a 24-week course – which has come under much scrutiny from the media and patient groups: however, the fact that it is demonstrably more effective than its rivals makes its case compelling.
In the latest study, patients with HIV and HCV genotype 1, 2 or 3 received the oral, interferon-free combination for 12 or 24 weeks. Patients infected with HCV genotype 1a had a higher rate of SVR than those with genotype 1b, perhaps because of the small number of patients with 1b infection.
Importantly, the study detected no ‘untoward effects’ of Sovaldi and ribavirin on HIV disease or its treatment with antiretrovirals. This means the combination can be co-administered with a wide range of antiretroviral drugs including those that induce (efavirenz), inhibit (ritonavir) or are metabolised by (darunavir or atazanavir) these enzymes, the study authors point out.
More than a quarter of the patients in the study were not eligible for interferon-containing HCV treatment regimens because of contraindications – making the Sovaldi combination a significant treatment option.
Among patients with HCV genotype 3 there was a substantially higher rate of SVR in treatment-experienced patients treated for 24 weeks with sofosbuvir and ribavirin (94%) – than in those treated for 12 weeks (67 per cent).
Yet while the results are good, there are limitations to the study – not least the underrepresentation of patients with cirrhosis (10%) and women (17 per cent).
Also, relatively few patients with advanced HIV disease (AIDS or low CD4 cell count) were enrolled, which means additional studies are needed.
Adam Hill
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