Separate clinical trials for HIV- HCV coinfected patients are NOT a necessity. Patrick Ingiliz, Berlin
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1 Separate clinical trials for HIV- HCV coinfected patients are NOT a necessity Patrick Ingiliz, Berlin
2 Back in the days when HCV genotype 1 was the problem SVR (%) % PRESCO HIV/HCV Peg2a/RBV 44% ADVANCE HCV mono Peg2a/RBV 75% ADVANCE HCV mono Telaprevir12 74% n= Study 110 HIV/HCV Telaprevir12 Side effects Interactions Núñez M, et al. AIDS Res Hum Retroviruses. 2007;23: Poordad et al., NEJM 2011;364: Jacobson IM, et al, NEJM 2011;364:
3
4 What s the bottom line since 2014? Indications for HCV treatment in HIV/HCV coinfected patients are identical to those in HCVmono-infection (Recommendation A1) (EASL) Same treatment regimens can be used in HIV/HCV patients as in patients without HIV infection, as the virological results of therapy are identical (Recommendation A1) (EASL) EASL recommendations April Accessed October Available at:
5 Is he or is he not?
6 Genotype 3? Cirrhotic? High viral load?
7 Why do we perform clinical trials? a) To answer a new research question? b) To get access to new drugs? c) To get a nice author position on a scientific paper?
8 What were the research questions answered by the last coinfection trials (2015)? a) ION-4: Sofosbuvir/Ledipasvir x 12 weeks b) Turquoise-1: Paritaprevir/r/Ombitasvir/Dasabuvir/RBV x weeks c) Ally-2: Daclatasvir/Sofosbuvir for 8-12 weeks
9 ION-4: SOF/LDV x 12 weeks in HIV/HCV GT1/4 Conclusions: The IFN-free, RBV-free, single tablet regimen of LDV/SOF administered once daily for 12 weeks is highly effective and well tolerated in treatment-naïve and experienced, genotype 1 or 4 HCV-infected patients with HIV- 1 co-infection, including those with cirrhosis. Naggie S et al. NEJM 2015
10 Turquoise-1: 3D (Paritaprevir/r/Ombitasvir/Dasabuvir) + RBV in HIV/HCV GT1 3D + RBV 12 weeks 24 weeks Conclusions and Relevance: 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 co-infected with HCV genotype 1 and HIV- 1 whether treated for 12 or 24 weeks. Further phase 3 studies of this regimen are warranted in patients with co-infection. Sulkowski et al., JAMA 2015
11 Ally-2: Sofosbuvir plus Daclatasvir for 8-12 weeks in HIV/HCV GT1-6 CONCLUSIONS: Among previously untreated HIV-HCV coinfected patients receiving daclatasvir plus sofosbuvir for HCV infection, the rate of sustained virologic response across all genotypes was 97.0% after 12 weeks of treatment and 76.0% after 8 weeks. Wyles D et al., NEJM 2015
12 Drug-drug-interactions between ARVs and DAAs NRTIs NNRTIs Protease Inhibitors Entry/ Integrase Inhibitors Abacavir Didanosine Emtricitabine Lamivudine Stavudine Tenofovir DF Zidovudine Efavirenz Etravirine Nevirapine Rilpivirine ATV; ATV/RTV DRV/RTV; DRV/COBI Fosamprenavir Lopinavir Saquinavir Dolutegravir Elvitegravir/cobicistat Maraviroc Raltegravir SMV SOF OMV/PTV/ LDV/ RTV SOF + DSV DCV No clinically significant interaction expected Potential interaction may require dosage adjustment, altered timing of administration or additional monitoring Do not coadminister For more information: EASL clinical practice guidelines 2015.
13 So what is the difference between HIV-HCV coinfected and HCV monoinfected patients? Table 1: Demographic of study cohort (medians and IQR) HCV HIV/HCV p n male 375 (55%) 194 (90%) <0.05 age (years) 55 (47 63) 48 (42 53) baseline HCV-RNA (IU/mL) 1.2 x10 6 (0,4 x x10 6 ) 1.3 x10 6 (0.28 x x10 6 ) baseline ALT (IU/mL) 64 (42 107) 67 (43 130) baseline HIV-RNA <20 copies/ml not applicable 176/201 (88%) baseline CD4+ cells/µl not applicable 614 ( ) cirrhosis 186 (27%) 28 (13%) <0.05 Opioid substitution 125 (18%) 41 (19%) Naive/pretreated 204 (30%) / 376 (55%) 73 (34%) / 114 (53%) GT (96%) 173 (81%) GT 4 29 (4%) 42 (19%) <0.05 SOF+PegIFN+RBV 77 (11%) 48 (22%) <0.05 SOF+DCV+/-RBV 92 (13%) 29 (14%) SOF+SMV 31 (5%) 6 (3%) SOF+LDV+/-RBV 385 (56%) 117 (54%) OBV+PTV/r+/-DSV+/-RBV 92 (13%) 8 (3%) Mauss et al. #1156, AASLD 2015
14 MSM and recreational drugs Drug GBMHS 2011 n=6861, 12M UK Gym survey, n=749, 12M ASTRA 2011/12 n=2248, 3M RFL ASTRA N=651, 3M Any recreational Cocaine Ecstasy Ketamine Mephedrone Crystal meth GBL/GHB Amyl nitrate Cannabis Courtesy: Mike Youle, Royal Free Hospital London
15 Ingiliz et al., manuscript submitted MSM and reinfection
16 HIV patients are getting old and fat just like everybody else n = 1286 Follow-up: Crum-Cianflone, N et al. PlosOne, 2010
17 Thank you for your attention
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