CATIE’s HepC Info Update 6.5

New and Noteworthy

Holkira Pak cures 94% of people co-infected with Hep C and HIV
High cure rates for Harvoni in people co-infected with HIV and Hep C
Hep C testing program in an emergency department finds undiagnosed older adults with Hep C

In a small clinical trial, 12 weeks of treatment with Holkira Pak and ribavirin in people co-infected with Hep C and HIV cured the hepatitis C infection in 94% of participants, reported researchers in the Journal of the American Medical Association.

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

• 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.

All participants had genotype 1 hepatitis C virus. The majority of participants were white and male, with an average age of 51. More than half of the participants had absent or mild liver damage. Participants were taking stable antiretroviral therapy (ART) for their HIV infection and had CD4 counts of at least 200 cells/mm³.

31 people participated in the 12-week treatment arm, with 94% being cured. There was also a 24-week treatment arm with 32 participants.  91% of these participants were cured. Treatment was well tolerated in both arms with the most common side effects being fatigue, insomnia, nausea and headache.

“In this open-label, randomized uncontrolled study, treatment with the all-oral, interferon-free 3D-plus-ribavirin regimen resulted in high SVR rates among patients coinfected with HCV genotype 1 and HIV-1 whether treated for 12 or 24 weeks,” the study authors concluded. (HIVandhepatitis.com, February 2015, in English)

High cure rates for Harvoni in people co-infected with HIV and Hep C

In another small clinical trial, 12 weeks of treatment with Harvoni in people co-infected with HIV and Hep C produced high hepatitis C cure rates of 98%, reported the researchers in the Journal of the American Medical Association.

Harvoni is a combination of two DAAs, ledipasvir and sofosbuvir that are co-formulated into one pill that is taken once per day to treat hepatitis C.

This study included 50 participants with genotype 1 Hep C virus. The majority of participants were African-American and men and the average age was 58. Approximately, one-quarter of participants had advanced liver damage (F3) but people with severe liver damage (cirrhosis) were excluded from the study.

98% of participants (48 out of 50) were cured of hepatitis C. The treatment was well tolerated.  The most common side effects were nasal congestion and muscle pain.

“In this open-label, uncontrolled, pilot study enrolling patients coinfected with HCV genotype 1 and HIV, administration of an oral combination of ledipasvir and sofosbuvir for 12 weeks was associated with high rates of SVR after treatment completion,” the researchers concluded. “Larger studies that also include patients with cirrhosis and lower CD4 T-cell counts are required to understand if the results of this study generalize to all patients coinfected with HCV and HIV.” (HIVandhepatitis.com, February 2015, in English)

Hep C testing program in an emergency department finds undiagnosed older adults with Hep C

According to research published in Hepatology, an emergency department (ED) Hep C testing program for adults born between 1945 and 1965 found that 1 in 9 people tested positive for Hep C antibodies.

In the Alabama, U.S., hospital where the program was carried out, all medically stable adults born between 1945 and 1965 who attended the ED over a period of 11 weeks were tested for Hep C antibodies, unless the participant opted out.

A positive Hep C antibody test means that a person has had Hep C at some point in their life but does not confirm that they currently have it. For some people their body clears the virus or they become cured through treatment. In these cases, antibodies remain in the body, so a further test (RNA test) is needed to confirm an active infection.

Of the 2325 previously undiagnosed older adults seen at the emergency department, over 1500 people received a Hep C antibody test. Just over 13% (289 people) opted out of Hep C screening.

Of the group that were tested, 11% (170 people) were positive for Hep C antibodies. 88% (150 people) of this group were tested for Hep C RNA and 68% (102 people) tested positive for Hep C RNA, meaning that they have active hepatitis C infection. A coordinator attempted to link participants who tested positive for Hep C RNA to hepatitis C care.

“We observed high prevalence of unrecognized chronic HCV infection in this series of Baby Boomers presenting to the ED, highlighting the ED as an important venue for high-impact HCV screening and linkage to care,” the researchers concluded. (HIVandhepatitis.com, February 2015, in English)