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The inaugural Hepatitis Session was held on the morning of the opening day of the meeting. This was held in the main hall and was almost full, reflecting the increased interest by the Infectious Diseases community in the rapidly advancing direct acting antivirals for the treatment of both HIV/HCV co-infection and HCV mono-infection.
In the afternoon, a symposium on HCV was held, with international experts discussing areas of unmet need
Press release from CROI
1. 12 wks of ABT-450r nonnucl inhibitor and ribavirin achieved SVR24 in >90% treatment-naïve HCV GT1 patients and 47% prior nonresponders. Lawtiz E, et al. A38
This presentation included final results from both the PILOT and CO-PILOT Phase II studies, where all patients with HCV mono-infection received 12 weeks combination therapy with the ritonivir-boosted protease inhibitor, ABT-450, ribavirin and one of two non-nucleoside NS5B polymerase inhibitors (ABT-072 and later ABT-333 In Cohorts 1, 2 and 3, 44/44 treatment naïve patients achieved end-of-trearment response, of whom 2 relapsed within the first 12 weeks post-treatment, 3 more relapsed between 12 and 24 weeks post and 1 between 24 and 48 weeks post. Late relapses (more than 12 weeks post-treatment) is not seen following conventional treatment with PEG/RBV or PI/PEG/RBV and this observation emphasizes the need for longer post-treatment follow-up. This regimen was less effective in treatment-experienced patients. In Cohort 4, only 8/17 patients achieved SVR. In view of these suboptimal results, Abbott has added a third DAA, the NS5A inhibitor ABT-267, to the combination of ABT-450/r and ABT-333, in order to prevent post-treatment relapse. Current Phase III studies of this regimen are underway.
2. STARTVerso 4: High Rates of Early Virologic Response in Hepatitis C Virus Genotype 1/HIV Co-infected Patients Treated with Faldaprevir + Pegylated Interferon and Ribavirin. Dieterich D, et al. LB40
Faldaprevir is an oral second generation protease inhibitor, which is administered once daily with no food effect and no need for ritonivir boosting. Interim study results from STARTversoTM 4 presented today at CROI+ show that 84 percent of hepatitis C (HCV) patients also infected with HIV had undetectable levels of HCV at week 12 of treatment with faldaprevir (BI 201335) combined with pegylated interferon and ribavirin (PegIFN/RBV), regardless of whether they were treatment-naïve or relapsed after prior treatment for HCV. Patients who achieved early treatment success may be eligible for 24 weeks rather than the standard 48 weeks of treatment with PegIFN/RBV. The most frequent adverse events were nausea (37%), fatigue (33%), diarrhoea (27%), headache (23%), and weakness (22%), similar safety results to those observed in HCV mono-infected treatment-naïve patients in prior faldaprevir clinical studies.
3. Telaprevir for Acute Hepatitis C Virus in HIV+ Men both Shortens Treatment and Improves Outcome. Fierer D. LB156
Pre-existing HIV infection reduced the rate of spontaneous clearance of HCV following acute HCV infection and also reduces the rate of successful eradication following interferon-based treatment. In this open-labeled study, 18 HIV+ patients with acute HCV infection received 12 weeks triple therapy with telaprevir- based triple therapy and 15 (83%) achieved SVR (compared to around 60% in historical controls treated with 48 weeks PEG/RBV). Although a small study, the higher SVR rate and shorter duration would support the future use of triple therapy for all cases of acute HCV superinfection in HIV+ patients. However, caution is needed with direct drug interactions with anti-HIV medications
4. ANRS-HC27 BocepreVIH Interim Analysis: High Early Virologic Response with Boceprevir + Pegylated Interferon + Ribivirin in Hepatitis C Virus/HIV Co-infected Patients with Previous Failure to Pegylated Interferon + Ribavirin. Poizot-Martin E, et al. A37
Preliminary on-treatment results were presented from this Phase II study of boceprevir-based triple therapy in HIV/HCV coinfected patients, who have failed to respond to prior PEG/RBV. Of 64 patients who commenced treatment, 12 stopped within 12 weeks (1 discontinued for personal reasons, 4 for adverse events and 7 for treatment failure). The remaining 52 patients all had undetectable HCV RNA at week 12 and week 16.
The prior response to PEG/RBV determined on-treatment response to boceprevir-based triple therapy: HCV RNA was undetectable after 16 weeks in 90% prior responder-relapsers, 61% in partial responders and 38% in prior Null responders.
The early on-treatment virologic response rates observed in this study are similar to those achieved with boceprevir in HCV mono-infection but post-treatment responses are awaited.
5. High Early Virological Response with Telaprevir-Pegylated-Interferon-Ribavirin in Treatment-experienced Hepatitis C Virus Genotype 1/HIV Co-infected Patients: ANRS HC26 TelapreVIH Study. Cotte L, et al. A36
Preliminary on-treatment results were presented from this Phase II study of telaprevir-based triple therapy in HIV/HCV coinfected patients, who have failed to respond to prior PEG/RBV. Of 69 patients who commenced treatment, 8 stopped within 12 weeks (1 discontinued for treatment failure and 7 for adverse effects). The remaining 61 patients all had undetectable HCV RNA at week 12 and week 16.
68/69 patients had at least one adverse event, of which the most common was anaemia requiring intervention (41/69 patients).
The early on-treatment virologic response rates observed in this study are similar to those achieved with telaprevir in HCV mono-infection but post-treatment responses are awaited.
6. Suppression of Viral Load through 4 Weeks Post-Treatment Results of a Once-daily Regimen of Simeprevir + Sofosbuvir with or without Ribavirin in Hepatitis C Virus GT 1 Null Responders. Lawitz E, et al. LB155
These are the long awaited results from an exciting Phase II study combining two of the most potent direct acting antivirals currently in clinical development – the nucleotide polymerase inhibitor sofosbuvir (GS-7977) and the protease inhibitor simeprevir (TMC-435), in the most difficult-to-treat patient population – those with HCV GT-1 infection, who had Null response to prior treatment with PEG/RBV. The assumption was that the NUC would prevent the emergence of resistance to the protease inhibitors. 12 weeks combination sofosbuvir/simeprevir achieved SVR4 in 26/27 patients whilst 12 weeks combination sofosbuvir/simeprevir/ribavirin achieved SVR4 in 13/14 patients. Additional arms of 24 weeks combination sofosbuvir/simeprevir±ribavirin had similar SVR but higher rates of AEs and treatment discontinuation.
The authors concluded that the combination sofosbuvir/simeprevir for 12 weeks was highly effective and did not require the addition of ribavirin or extension to 24 weeks.