1. HIV and HCV Update for the Pharmacist – June 2014 John J
HIV and HCV Update for the Pharmacist – June 2014 John J. Faragon, PharmD, BCPS, AAHIV-P Regional Pharmacy Director, NY/NJ AETC Pharmacist, Albany Medical Center

2. Objectives Discuss recent guidelines changes for HIV infection
Using patient cases, discuss the role of sofosbuvir and simeprevir in HIV/HCV co-infection
Review consensus guidelines for managing HIV/HCV coinfection

3. DHHS Guidelines Update 2014: Recommended Regimens in ARV Naives Regardless of Baseline CD4 and Viral Load
NNRTI – Based Regimen
Efavirenz/tenofovir/emtricitabine (AI)
PI – Based Regimens:
Atazanavir/ritonavir + tenofovir/emtrictiabine (AI)
Darunavir/ritonavir + tenofovir/emtricitabine (AI)
INSTI – Based Regimens:
Dolutegravir plus abacavir/lamivudine – ONLY if patient HLA-B*5701 negative (AI)
Dolutegravir plus tenofovir/emtricitabine (AI)
Elvitegravir/cobicistat/tenofovir/emtricitabine – ONLY if pre-ART CrCl >70ml/min (AI)
Raltegravir plus tenofovir/emtricitabine (AI)
May 2014 updated regimens and removed the previous designation of preferred regimens and now call them “recommended” regimens, and are classified as NNRTI, boosted PI, or INSTI based. In general regimens recommended consist of 2 NRTIs and one of the 3 other classes in addition.
Read regimens above and include caveats
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14

4. DHHS Guidelines Initial Recommended Regimens - 2014
Atripla
1/day
Reyataz/Norvir/Truvada
3/day
This slide provides the pill burden of preferred regimens and pictures of what the pills actually look like
Prezista/Norvir/Truvada
3/day
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14.

5. DHHS Guidelines Initial Recommended Regimens - 2014
Isentress (BID)/Truvada
3/day
Tivicay/Truvada OR Epzicom
2/day OR
This slide provides the pill burden of preferred regimens and pictures of what the pills actually look like
Stribild
1/day
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14.

6. DHHS Guidelines Update 2014: Recommended Regimens, ARV Naives, ONLY if Pre ART Viral Load <100,000 copies/ml
NNRTI – Based Regimen
Efavirenz + abacavir/lamivudine – ONLY if patient HLA-B*5701 negative (AI)
Rilpivirine/tenofovir/emtricitabine – ONLY if patient has CD4 count>200 cells/mm3 (AI)
PI – Based Regimens:
Atazanavir/ritonavir + abacavir/lamivudine (AI) – ONLY if patient is HLA-B*5701 negative
The regimens listed here are also from the 2014 DHHS Guidelines and are the recommended regimens, but only if viral loads are less than 100,000 copies/ml at baseline. In this class there are 2 NNRTI based regimens, and one PI based option.
Of concern here is that some regimens do not perform as well in patients with higher viral loads so the viral load cutoff designation is important to recognize with these regimens.
Read regimens above with caveats
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14

7. DHHS Guidelines Update 2014 Alternative Regimens in ARV Naives
PI – Based Regimen
Darunavir/ritonavir + abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative (BII)
Lopinavir/ritonavir (once or twice daily) plus abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative (BI)
Lopinavir/ritonavir (once or twice daily) plus tenofovir/emtricitabine (BI)
INSTI – Based Regimens:
Raltegravir + abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative
The following regimens are listed on DHHS as Alternative regimens and should be used if patients can not use or tolerate a recommended regimen.
Read regimens on slide
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14

8. Preferred NRTI Backbones in Pregnancy – DHHS Perinatal Guidelines, March 2014
Abacavir/lamivudine
Available as fixed dose combination, once daily dosing. Do NOT use in patients testing positive for HLAB*5701
Tenofovir/emtricitabine or lamivudine
Available as fixed dose combination, once daily dosing. Tenofovir may cause renal impairment
Zidovudine/lamivudine
Available as fixed dose combination. Most experience in pregnancy to date, but twice daily adminstration, and potential for hematologic toxicity
In this slide, I have summarized in table format the changes to the DHHS guidelines. READ CHART with caveats on right side.
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available at Accessed 5/2/14

9. Preferred PI, NNRTI Regimens in Pregnancy – DHHS Perinatal Guidelines, March 2014
Preferred PI Regimens
Atazanavir/ritonavir + preferred dual NRTI backbone
Once daily administration
Lopinavir/ritonavir + preferred dual NRTI backbone
Twice daily administration. Once daily dosing not recommended in pregnancy. May need to increase dosage in 3rd trimester
Preferred NNRTI Regimens
Efavirenz + preferred dual NRTI backbone initiated AFTER first 8 weeks of pregnancy
Teratogenicity in primates.
Preferred PI and NNRTI regimens in Pregnancy are also listed here and include comments/cavetas. Read Slidewith caveats on right
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available at Accessed 5/2/14

10. Current Medications for HCV
Older Medications
Pegylated Interferon – PegIntron or Pegasys
Ribavirin
Older Direct Acting Antivirals
Boceprevir (Victrelis)
Telaprevir (Incivek)
New Direct Acting Antivirals
Simeprevir (Olysio)
Sofosbuvir (Sovaldi)

11. Challenges with Older DAA
Telaprevir (Incivek)
Rash – Black Box Warning
Anemia – Worse than Pegylated interferon + Ribavirin alone
Needs interferon and ribavirin – brings all ADRs with it too
Anorectal adverse events challenging
Only for Genotype 1 – ie not pangenotypic
Response guided therapy/stopping rules
Drug Interactions complex, especially when treating co-infection
Large pull burden (6/day), TID, now BID frequency

12. Challenges with Older DAA
Boceprevir (Victrelis)
Dygeusia –Anemia – Worse than Pegylated interferon + Ribavirin alone
Needs interferon and ribavirin – brings all ADRs with it too
4 week lead in period
Only for Genotype 1 – ie not pangenotypic
Response guided therapy/stopping rules
Drug Interactions complex, especially when treating co-infection
Large pull burden (12/day), TID frequency

13. Contraindicated medications with boceprevir and telaprevir
Drug Class
Contraindicated With BOC[1]
Contraindicated With TVR[2,3]
Alpha 1-adrenoreceptor antagonist
Alfuzosin
Anticonvulsants
Carbamazepine, phenobarbital, phenytoin
Antimycobacterials
Rifampin
Ergot derivatives
Dihydroergotamine, ergonovine, ergotamine, methylergonovine
GI motility agents
Cisapride
Herbal products
St John’s wort
HMG CoA reductase inhibitors
Lovastatin, simvastatin
Oral contraceptives
Drospirenone
N/A
Neuroleptic
Pimozide
PDE5 inhibitor
Sildenafil or tadalafil when used for tx of pulmonary arterial HTN
Sedatives/hypnotics
Triazolam; orally administered midazolam
The actual list of absolute no-no medications, medications that cannot be utilized with either telaprevir or boceprevir, is summarized on this table. It includes alpha-1 adrenergic antagonists, certain anticonvulsants, certain antibacterial agents, ergot derivatives, GI motility agents, certain herbal products, the HMG CoA reductase inhibitors utilized to treat elevated serum cholesterol, oral contraceptives as we already mentioned, certain neuroleptics, phosphodiesterase inhibitors, and sedative hypnotic agents. These drugs listed on these table should not be utilized in patients receiving boceprevir or telaprevir at all. If patients are already on these medications, the physician should search for an alternative medication before starting therapy.
1. Boceprevir [package insert] Telaprevir [package insert] , 3.

14. Concurrent Medication Boceprevir allowed Telaprevir allowed
Atazanavir/ritonavir (Reyataz®/Norvir®) No
Yes
Darunavir/ritonavir (Prezista®/Norvir®)
Fosamprenavir/ritonavir (Lexiva®/Norvir®)
No, not studied to date
Lopinavir/ritonavir (Kaletra®)
Efavirenz (Sustiva®)
Yes, increase TLV dose to 1125mg Q8H
Etravirine (Intelence®)
Yes, reduced etravirine levels reported
Rilpivirine (Edurant®)
Tenofovir (Viread®)
Yes, monitor renal fx
Raltegravir (Isentress®)
Elvitegravir (in Stribild®) ??
Dolutegravir (Tivicay®)
Maraviroc (Selzentry®)
Yes, MRV 150mg BID

15. Daclatasvir
Ledipasvir
ABT- 267
Telaprevir
Boceprevir
Simeprevir
Faldapravir
ABT-450
Sofosbuvir
ABT-333

16. Simeprevir FDA Approved November 22, 2013
FDA Panel recommended approval October 24, 2013, formal approval November 22, 2013
Recommend approval of simeprevir, an HCV NS3/4A protease inhibitor, in combination with pegylated interferon/ribavirin
150 mg once-daily for use by genotype 1 hepatitis C patients, either treatment-naive or prior non-responders, with food
No dosage recommendations for East Asian ancestry subjects
Janssen Research and Development. FDA Advisory Committee Recommends Approval of Simeprevir
for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients. Press release. October 24, 2013.
Accessed June 4, 2014.

17. Simeprevir Key Points Q80K mutation screening will be important
GT1a polymorphism
Substantial reduction in SVR rates if present at baseline
Pre-treatment screening recommended
Serious photosensitivity reactions have been observed during combination therapy
Use sun protection measures and limit sun exposure. Consider discontinuation if a photosensitivity reaction occurs.
Rash has been observed during combination therapy Discontinue OLYSIO if severe rash occurs.
Caution in Sulfa allergic, simeprevir is a sulfonamide
Hyperbilirubinemia also reported
Janssen Research and Development. FDA Advisory Committee Recommends Approval of SimeQ*)previr
for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients. Press release. October 24, 2013.
Accessed June 4, 2014.

18. Simeprevir Key Points
Duration of Treatment with Simeprevir, peg-interferon alfa, ribavirin
Simeprevir, peg-interferon alfa + ribavirin
Peg-interferon alfa + ribavirin
Total treatment duration
Naïve, prior relapser, including cirrhosis
First 12 weeks
Additional 12 weeks
24 weeks
Prior non-responders, including cirrhosis
Additional 36 weeks
48 weeks
Simeprevir Stopping Rules
Week 4, > 25IU/mL
Discontinue simeprevir, peg-interferon and ribavirin
Week 12, > 25IU/mL
Discontinue peg-interferon alfa and ribavirin (simeprevir complete at week 12)
Week 24, > 25IU/mL
Discontinue peg-interferon alfa and ribavirin
Janssen Research and Development. FDA Advisory Committee Recommends Approval of SimeQ*)previr
for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients. Press release. October 24, 2013.
Accessed June 4, 2014.

19. Simeprevir with PEG/RBV, GT 1 HIV/HCV CoInfection Design
Treatment naïve or Prior relapser
Prior partial or
Null responder
SMV + PR
Follow-up PR
RGT
Primary Analysis
Dieterich D et al. CROI 2014; Abst 24

20. Simeprevir + PEG/R,GT1 HIV/HCV CoInfection: SVR 12 Results, ITT
Dieterich D et al. CROI 2014; Abst 24

21. Drug Interactions Considerations
Simeprevir
Mild inhibitor of CYP1A2 activity and intestinal CYP3A4
Does not affect hepatic CYP3A4 activity
Inhibits OATP1B1/3 and P-glycoprotein
Multiple drug interactions expected

22. Medications to Avoid with Simeprevir
Medication and or Class
Rationale for Avoiding with Simeprevir
Anticonvulsants - carbamazepine, oxcarbazepine, phenobarbital, phenytoin
Co-administration with these medications is likely to reduce concentrations of simeprevir and lead to reduced simeprevir efficacy. Co-administration not recommended.
Antibiotics – clarithromycin, erythromycin, telithromycin
Co-administration with these medications is likely to increase concentrations of either simeprevir or the antibiotic due to CYP3A4 and P-glycoprotein (P-gp) inhibition. Co-administration not recommended.
Antifungals – fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
Co-administration with these medications is likely to increase concentrations of simeprevir due to CYP3A4 inhibition from the antifungals. Co-administration not recommended.
Antimycobacterials – rifampin, rifabutin, rifapentine

23. Medications to Avoid with Simeprevir
Medication and or Class
Rationale for Avoiding with Simeprevir
Corticosteroids – dexamethasone
Co-administration with dexamethasone is likely to decrease concentrations of simeprevir and lead to reduced simeprevir efficacy. Co-administration not recommended.
Propulsive – cisapride
Co-administration with cisapride may result in increased concentrations of cisapride leading to potential cardiac arrhythmias.
Herbal products – Milk Thistle, St. John’s Wort
Co-administration with milk thistle is likely to increase concentrations of simeprevir. Co-administration not recommended.
Co-administration with St. John’s Wort is likely to reduce concentrations of simeprevir leading to reduced simeprevir efficacy, due to intestinal P-glycoprotein (P-gp) induction associated with St. John’s Wort.

24. Simeprevir and HIV Medications
Concurrent Medication
Recommendation
HIV Protease Inhibitors
All HIV PIs
Significant increases or decreases in simeprevir levels expected when used with any HIV protease inhibitor, when used with or without ritonavir. Co-administration not recommended
HIV Non Nucleoside Reverse Transcriptase Inhibitors
Efavirenz (Sustiva®), Etravirine (Intelence®),
Nevirapine (Viramune®)
Significant reductions in simeprevir levels and reduced simeprevir efficacy due to CYP3A4 induction. Co-administration not recommended.
Rilpivirine (Edurant®)
Concurrent use at standard doses acceptable.

25. Simeprevir and HIV Medications
Concurrent Medication
Recommendation
HIV Integrase Strand Transfer Inhibitors
Dolutegravir (Tivicay®)
Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of simeprevir.
Elvitegravir (contained in Stribild®)
Significant increase in simeprevir levels expected when used with a cobicistat containing regimen. Co-administration not recommended.
Raltegravir (Isentress®)
Concurrent use at standard doses acceptable.
HIV Entry Inhibitors
Maraviroc (Selzentry®)
HIV Nucleoside/Nucelotide Reverse Transcriptase Inhibitors
All NRTIs

26. Sofosbuvir FDA Approved, December 6, 2013
FDA Panel recommended approval October 25, 2013
Recommendation covers both use with interferon-based therapy for treatment-naive people with HCV genotypes 1 or 4
Also use in dual therapy with ribavirin for people with easier-to-treat HCV genotypes 2 or 3 - the first approved interferon-free regimen
Gilead Sciences. FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic
Hepatitis C Infection. Press release. October 25, Accessed June 4, 2014.

27. Sofosbuvir + PEG-interferon + ribavirin Sofosbuvir + ribavirin
Sofosbuvir Key Points
Indication
NS5B nucleotide polymerase inhibitor for the treatment of chronic HCV as a component of combination anitiviral treatment regimen
400 mg tablet, once daily dosing, with no food restrictions
HCV Mono-infected and HCV/HIV Co-infected
Treatment
Duration
Genotype 1 or 4
Sofosbuvir + PEG-interferon + ribavirin
12 weeks
Genotype 2
Sofosbuvir + ribavirin
Genotype 3
24 weeks
Accessed June 4, 2014.

28. Sofosbuvir Key Points
Sofosbuvir + ribavirin ALONE for 24 weeks can be considered for GT1 if intolerant to interferon
No dosage recommendation can be made in patients with severe renal impairment or ESRD – up to 20 fold increase in SOF metabolite
Contraindications – Monotherapy, also ribavirin birth defects
Accessed June 4, 2014.

29. Sofosbuvir Key Points Adverse Events Additional info Drug Interactions
Headache and fatigue most common
Anemia and insomnia, nausea when adding peginterferon + ribavirin
Additional info
HIV/HCV coinfection studied, also data on patients with HCC awaiting liver transplantation studied
Drug Interactions
Intestinal PGP inducers likely to reduce levels –ie rifampin, St Johns Wort
Accessed June 4, 2014

30. PHOTON-1 Trial in HIV/HCV Co-infection
Open-label, phase 3 study of sofosbuvir plus weight-
based ribavirin in coinfection, genotypes 1, 2 or 3.
GT1,
Naive
GT2/3, Naive
SOF + RBV, n=114
SOF + RBV, n=68
SOF + RBV, n=41
GT2/3,
Experienced
SVR 12
SVR 24
Week
Naggie S et al. CROI 2014; Abst 26.

31. PHOTON-1: Results
Naggie S et al. CROI 2014; Abst 26

32. PHOTON-1: Results
Allowable ARVs: NRTIs, atazanavir/r, darunavir/r, rilpivirine & raltegravir
Most virologic failures had relapse
No sofosbuvir resistance seen
Naggie S et al. CROI 2014; Abst 26

33. PHOTON-1 Adverse Events
Patients, % AEs
24 Weeks SOF+RBV(n=155)
12 Weeks SOF+RBV(n=68)
Fatigue 39 35
Insomnia 15 21
Headache 14 13
Nausea 18
Diarrhea 11 9
Irritability 10
URI 12
Grade 3-4 AEs
Serious AEs 6 7
Treatment DC due to AEs 3 4
Death 1
Naggie S et al. CROI 2014; Abst 26

34. Drug Interactions Considerations
Sofosbuvir
Substrate for P-glycoprotein and breast cancer resistance protein
Intracellular metabolism mediated by hydrolase and nucleotide phosphorylation pathways
Minimal drug interactions expected

35. Medications to Avoid with Sofosbuvir
Medication and or Class
Rationale for Avoiding with Sofosbuvir
Anticonvulsants – carbamazepine, oxcarbazepine, phenobarbital, phenytoin
Co-administration with these medications is likely to reduce concentrations of sofosbuvir leading to reduced sofosbuvir efficacy. Co-administration not recommended.
Antimycobacterials – rifampin, rifabutin, rifapentin
Co-administration with these medications is likely to reduce concentrations of sofosbuvir leading to reduced sofosbuvir efficacy due to intestinal P-glycoprotein (P-gp) induction from rifampin.
Herbal products – St. John’s Wort
Co-administration with these medications is likely to reduce concentrations of sofosbuvir leading to reduced sofosbuvir efficacy due to intestinal P-glycoprotein (P-gp) induction associated with St. John’s Wort.

36. Sofosbuvir and HIV Medications
Concurrent Medication
Recommendation
HIV Protease Inhibitors
All HIV PIs, with or without ritonavir, except tipranavir
Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of sofosbuvir.
Tipranavir (Aptivus®)
Co-administration not recommended
HIV Non Nucleoside Reverse Transcriptase Inhibitors
All NNRTIs
Concurrent use at standard doses acceptable.

37. Sofosbuvir and HIV Medications
Concurrent Medication
Recommendation
HIV Integrase Strand Transfer Inhibitors
Dolutegravir (Tivicay®)
Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of sofosbuvir.
Elvitegravir (contained in Stribild®)
Raltegravir (Isentress®)
Concurrent use at standard doses acceptable.
HIV Entry Inhibitors
Maraviroc (Selzentry®)
HIV Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
All NRTIs

38. Post-treatment follow-up
COSMOS Study Design
SMV+SOF+RBV
Post-treatment follow-up
SMV+SOF
+ RBV
Randomized
2:1:2:1
Arm1
Arm2
Arm 3
Arm 4
Cohort 1 – Metavir F0-F2, prior null responders
Cohort 2 – Metavir F3-F4, prior null responders or naives
Primary Endpoint: SVR12
Secondary Endpoints: RVR, Tx failure, relapse rate, safety
Lawitz, etal. 49th EASL, April 9-13, 2014.

39. COSMOS, Baseline Characteristics
SMV/SOF+ RBV
24 weeks
n=30
SMV/SOF
n=16
SMV/SOF + RBV 12 weeks
n=27
SMV/SOF 12 weeks
n=14
Total
n=87
Male, % 70 44 74 71 67
White/African American
97/3
81/19
93/7
86/14
91/9
Hispanic, Latino 10 31 19 14 17
Median Age 58 57
Median BMI 28 29 27 32
GT 1a 77 75 82 79 78
GT 1a, Q80K 48 42 36 30 40
Median HCV VL
6.3
6.6
6.7
Null Responders 50 56 54
IL28B, non CC 73 88 85
Cirrhosis 43 63 41 47
Lawitz, etal. 49th EASL, April 9-13, 2014.

40. COSMOS, SVR 12 (ITT) Results
28/30
16/16
25/27
13/14
82/87
24 weeks weeks Overall
Lawitz, etal. 49th EASL, April 9-13, 2014.

41. www.hcvguidelines.org Released 1/29/14!

42. HIV/HCV Co-Infection, GT1
Preferred
Alternative
Treatment-naïve, prior PEG/RBV relapsers, IFN eligible:
SOF + PEG/RBV(WB) x 12 weeks
IFN ineligible:
SOF + RBV(WB) x 24 weeks
SOF + SMV ± RBV(WB) x 12 weeks
Treatment experienced, prior PEG/RBV nonresponders, regardless of IFN eligibility:
SMV x 12 weeks + PEG/RBV(WB) x 24 weeks
None
Treatment experienced, prior PEG/RBV
nonresponders
IFN eligible: SOF + PEG/RBV(WB) x 12 Weeks
IFN ineligible: SOF + RBV(WB) x 24 Weeks
Not Recommended:
TVR + PEG/RBV x 24 or 48 weeks (RGT), BOC + PEG/RBV x 28 or 48 weeks (RGT)
PEG/RBV x 48 weeks, SMV x 12 weeks + PEG/RBV x 48 wks

43. HIV/HCV Co-Infection, GT2
Preferred
Alternative
All patients, regardless of treatment history:
SOF + RBV(WB) x 12 weeks
Treatment naive and prior PEG/RBV relapsers:
None
Treatment experienced, prior PEG/RBV
Nonresponders:
IFN eligible: SOF + PEG/RBV(WB) X 12 Weeks
IFN ineligible: None
Not Recommended:
PEG/RBV x weeks, or any regimen with TVR, BOC, or SMV

44. HIV/HCV Co-Infection, GT3
Preferred
Alternative
All patients, regardless of treatment history:
SOF + RBV(WB) x 24 weeks
Treatment naïve, PEG/RBV relapsers:
None
Treatment experienced, prior PEG/RBV
Nonresponders:
IFN eligible: SOF + PEG/RBV(WB) X 12 weeks
IFN ineligible: None
Not Recommended:
PEG/RBV x weeks, Any regimen with TVR, BOC, or SMV

45. HIV/HCV Coinfection, GT4
Preferred
Alternative
All patients, regardless of treatment history:
IFN eligible: SOF + PEG/RBV(WB) x 12 weeks
IFN ineligible: SOF + RBV(WB) x 24 weeks
None
Not Recommended:
PEG/RBV x 48 weeks, any regimen with TVR or BOC

46. HIV/HCV Coinfection, GT 5,6
Preferred
Alternative
All patients, regardless of treatment history:
SOF + PEG/RBV(WB) x 12 weeks
None
Not Recommended:
PEG/RBV x 48 weeks, any regimen with TVR, BOC, or SMV

47. Standard Dosing Sofosbuvir – 400mg once daily
Simeprevir – 150mg once daily
Peg Interferon – 180mcg once weekly
Ribavirin – weight based dosing
<75kg – 1000mg daily in divided doses
≥75 kg – 1200mg daily in divided doses

48. IFN Ineligible Definitions
Intolerance to IFN
Autoimmune hepatitis and other autoimmune disorders
Hypersensitivity to PEG or any of its components
Decompensated hepatic disease
History of depression, or clinical features consistent with depression
A baseline neutrophil count below 1500/μL, a baseline platelet count below 90,000/μL or baseline hemoglobin below 10 g/dL
A history of preexisting cardiac disease

49. Investigational HCV Medications

50. Select Investigational Medications
All oral, interferon free likely in October 2014
Ledipasvir (FDC with sofosbuvir)
ABT-450/ritonavir+ABT-267 (ombitasvir) (FDC) plus ABT-333 (dasabuvir) BID
Other meds moving forward (not all inclusive)
Daclatasvir + asunaprevir + BMS
Faldaprevir
MK-5172, MK-8742
GS-9669, GS-9451, GS-5816

51. Select HIV/HCV Resources

52. www.hcvguidelines.org Released 1/29/14!

54.
CLICK HERE

55.
CLICK HERE

56. NY/NJ AETC – www.nynjaetc.org

57. NY/NJ AETC – www.nynjaetc.org

58.
Good reference

59. NY/NJ AETC – www.nynjaetc.org

60. NY/NJ AETC – www.nynjaetc.org