Sofosbuvir/ledipasvir is effective for people with HIV/HCV co-infection in real-world clinical practice
The sofosbuvir/ledipasvir (Harvoni) co-formulation used in real-world clinical practice produced good sustained virological response rates similar to those seen in clinical trials for HIV-positive people who have co-infection with hepatitis C, according to a pooled analysis presented at the 2016 Liver Meeting conference, organised by the American Association for the Study of Liver Diseases (AASLD) this month in Boston.
A new three-drug co-formulation containing Merck's grazoprevir plus the investigational agents MK-3682 and ruzasvir was highly effective for people with hepatitis C virus (HCV) genotypes 1, 2 or 3, with sustained response rates of 86 to 100% depending on treatment duration, according to study results presented at the conference.
More than 90% of HIV-positive people treated with direct-acting antivirals for hepatitis C – including many with liver cirrhosis – achieved sustained virological response and few discontinued treatment due to side-effects, showing that real-world clinical practice can produce results as good as those seen in formal clinical trials, according to results from a Spanish study presented at the conference.
A three-drug regimen of sofosbuvir, velpatasvir and voxilaprevir taken for 8 weeks demonstrated an overall sustained virological response rate of 95% for previously untreated people with all hepatitis C virus (HCV) genotypes, while a 12-week regimen cured 96-97% of people who experienced prior treatment failure on direct-acting antivirals (DAAs), according to a set of phase 3 studies presented at the conference.
Grave weaknesses in hepatitis C screening and linkage to care are still widespread in the United States and threaten to leave a large proportion of baby boomers with hepatitis C untreated, presentations at the conference showed.
AbbVie’s combination of glecaprevir and pibrentasvir cured at least 98% of people with hepatitis C in three large clinical trials covering five out of six genotypes of the virus, and is likely to receive marketing approval in the United States and European Union as the first ribavirin-free pangenotypic direct-acting antiviral combination next year, the conference heard.
AbbVie’s pangenotypic combination of glecaprevir and pibrentasvir cured almost all of the hardest-to-treat genotype 3 patients – those with cirrhosis and/or previous treatment experience – in a phase II trial, and looks suitable for use as an 8-week regimen in genotypes 2, 4, 5 and 6, according to results of studies presented at the conference.
If sufficient money is available to pay for direct-acting antivirals (DAAs), the US Veterans Affairs (VA) could cure the majority of veterans under its care of hepatitis C within three years, and has already shown it has the capacity to initiate almost 7000 people on treatment in a single month, George Ioannou of University of Washington, Seattle, reported at the conference.
Tenofovir alafenamide (TAF), a new lower-dose pro-drug, matches the older tenofovir disoproxil fumarate (TDF) for antiviral activity against hepatitis B virus (HBV) but causes less bone mineral loss, according to a report at the conference. The US Food and Drug Administration has approved stand-alone TAF for hepatitis B treatment and a European Medicines Agency committee issued a positive opinion.
Grazoprevir/elbasvir + sofosbuvir highly effective for hard-to-treat genotype 3 hepatitis C patients
A triple regimen of grazoprevir/elbasvir (Zepatier) plus sofosbuvir (Sovaldi) without ribavirin cured 96% of previously untreated and 97% of treatment-experienced people with hepatitis C virus (HCV) genotype 3 and liver cirrhosis, matching rates seen in easier-to-treat patient groups, according to results from the C-ISLE study presented at the conference.