CATIE HepCinfo Update 7.8

Hep C Info UpdatesHolkira Pak is now indicated for people with HIV/Hep C co-infection or post liver transplant

The Holkira Pak product monograph has been updated to include that people who are co-infected with HIV and Hep C or who have had a liver transplant can be treated with this drug combination.

Holkira Pak is a combination of three direct-acting antivirals (DAAs). DAAs attack the ability of the Hep C virus to make copies of itself. Holkira Pak consists of:

  • paritaprevir, a protease inhibitor, which is boosted with ritonavir
  • ombitasvir, an NS5A inhibitor
  • dasabuvir, an NS5B inhibitor

Paritaprevir/ritonavir and ombitasvir are co-formulated into one tablet. Dasabuvir is its own tablet. Holkira Pak may also be taken with ribavirin. It is approved in Canada for genotype 1 virus.

Sofosbuvir, velpatasvir and GS-9857 effective for people with treatment experience

A mid-stage clinical trial of the experimental Hep C treatment combination sofosbuvir, velpatasvir and GS-9857 showed high cure rates for almost all genotypes, reported researchers at the European Association for the Study of the Liver’s International Liver Congress (EASL 2016) in Barcelona.

Participants took sofosbuvir and velpatasvir, which are co-formulated into one pill, and GS-9857 daily for 12 weeks.

This trial included 128 participants from the U.S. and New Zealand. A majority of participants (75%) were men, most were white, and their average age was 58 years.

About half of participants had HCV genotype 1, 16% had genotype 2, 27% had genotype 3, and 7% had genotype 4 or 6. Almost half of participants had liver cirrhosis.

About 80% of participants had previously used direct-acting anti-virals (DAAs) and the rest had taken interferon and ribavirin without DAAs.

The overall cure rate was 99%. The treatment was generally safe and well-tolerated. The most common side effects were headache, fatigue, diarrhea and nausea but these were mostly mild or moderate.

Late-stage trials will study this treatment with a larger group of people. (, April 2016, in English)

Hydromorphone is as effective as pharmaceutical heroin for managing opioid use issues

Hydromorphone and pharmaceutical-grade heroin are both equally effective for the management of chronic heroin use issues among people who have not previously benefitted from methadone or buprenorphine, reported researchers in JAMA Psychiatry.

Pharmaceutical-grade heroin (diacetylmorphine) has been established as an effective treatment for people with severe opioid use issues. However it is not available in most countries.

This late-stage trial included 202 people who have been using street opioids long term in Vancouver. Participants were recruited between December 2011 and December 2013. About 70% were men and the average age was 44 years. Participants had been injecting heroin for an average of 15 years and had previously tried methadone treatment without success.

Participants were randomly assigned to receive either injectable diacetylmorphine or hydromorphone up to three times daily for six months at a clinic with an interdisciplinary healthcare team.

The researchers measured whether participants used street-acquired heroin or other opiates and the proportion of heroin-positive urine tests.

Participation was high, with greater than 80% of participants still in both groups after six months.

People receiving either treatment used street-acquired heroin or other opiates less often (three to five days a month) compared to prior to participation in the study (almost daily use). Most analyses, including urine tests, showed hydromorphone and diacetylmorphine were similarly effective at reducing use of street acquired drugs.

“Taken together, these results suggest that injectable hydromorphone is as effective as injectable diacetylmorphine for long-term injection street opioid users not currently benefiting from available treatments,” the researchers concluded.