Published: Nov 5, 2013 | Updated: Nov 5, 2013
By Ed Susman , Contributing Writer, MedPage Today
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal
WASHINGTON -- Combination therapy to treat patients co-infected with HIV and hepatitis C virus (HCV) can achieve a high percentage of virologic end-of-treatment response to the hepatitis infection without affecting suppression of the HIV, researchers reported here.
At 48 weeks, 83% of patients had a sustained response to hepatitis infection with the combination of telaprevir (Incivek)-pegylated interferon and ribavirin, and maintained suppression of HIV to less than 50 copies/mL, said Laurent Cotte, MD, co-ordinator of the study for the French National Agency for Research (ANRS), and a physician at Centre Hospitalier Universitaire de Lyon.
More than half the patients with HIV in France are co-infected with hepatitis C virus making this population of patients difficult to treat, Cotte told MedPage Today at the annual meeting of the American Association for the Study of Liver Diseases.
"Despite a high discontinuation rate related to toxicity (20.3%), a very high virological response rate was achieved at Week 48 with the combination therapy in patients who were already experienced with pegylated-ribavirin HIV co-infected patients," Cotte said at his poster presentation.
Cotte and his colleagues began dosing a cohort of 69 patients; 8 discontinued treatment before 16 weeks because of adverse events and 10 discontinued between 16 weeks and the end of the study.
At Week 16, 88% of the patients in the intention-to-treat analysis had achieved a virologic response to the telaprevir-based combination.
By the end of the study, 83% of the intention-to-treat population had maintained that response, he said. Cotte noted that the patients are being followed to determine if they can sustain the response and, in effect, cure the patient of the hepatitis C infection.
All the patients were treated with highly active anti-retroviral therapy and had controlled their HIV to undetectable levels using the 50-copies/mL assay. "We had one patient who recorded one reading of 59 copies/mL but that was just a blip," Cotte said. "Otherwise there was no problem in these patients staying HIV-suppressed,"
Cotte acknowledged the sweeping advances being made in treatment for HCV, noting that pegylated interferon and ribavirin may soon be obsolete drugs. "When we started this study, this was the standard of care treatment," he said. "But even with these newer regimens, this study will be the set point that shows what we will need for this population. It shows that these patients can be treated effectively."
"We had a very good virological response -- 83% of the patients achieving that by week 48. We also had significant adverse events, notably anemia, the need for erythropoietin, the need for blood transfusion and reduction in ribavirin dosing. Over the course of 48 weeks, about 70% of patients experienced those Grade 3 or Grade 4 events."
The median age of the patients in the study was 50. About 85% of the patients were non-black; 80% were men; about 55% were injecting drug users.
"About 30% of the 1 million patients infected with HIV in the United States are co-infected with hepatitis C virus," said Raymond Chung, MD, director of hepatology and associate professor of medicine at Massachusetts General Hospital/Harvard Medical School. "These are difficult patients to treat. We first have to make sure that the antiretroviral drugs used in treatment of HIV do not have drug-drug-interactions with the antiviral medication."
In the study 49% of the patients were on the antiretroviral atazanavir (Reyataz) in combination with ritonavir; 19% were on efavirenz (Sustiva) and 17% were on raltegravir (Isentress), Cotte reported.
Chung told MedPage Today that in Cotte's study the patients were taking those medications. "Historically, we were able to reach a sustained virologic response in about 50% of patients with infection with HCV alone. But if patients were co-infected with HIV, the success rate was about 35%."
"What these new combinations have shown is that we can level the playing field for HIV co-infected patients," Chung said. "We now expect to achieve about a 75% sustained virologic response with drugs such as telaprevir. This study fits into that formula."
He said that new all-oral regimens are expected to further change treatment to benefit these patients.
Cotte had no disclosures.
Chung disclosed commercial relationships with Idenix, Enanta, Gilead, Merck and Mass Biologic.
Primary source: American Association for the Study of Liver Diseases
Source reference: Cotte L, et al "High end-of-treatment (EOT) response rate with telaprevir-pegIFN-RBV in treatment-experienced HIV co-infected patients with HCV genotype 1: ANRS HC26 telapreVIH study" AASLD 2013.