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Pharmacotherapy of HIV

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HIV, Pharmacotherapy of HIV, Anti retroviral therapy, New advances in AIDS/HIV

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Pharmacotherapy of HIV

  1. 1. PHARMACOTHERAPY OF HIV/AIDS Dr Manjeeta Gupta
  2. 2. Structure of HIV 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 2 Antigenic strains : HIV-1 & HIV-2 HIV-1(virulent strain) Worldwide HIV-2 (less virulent) West Africa
  3. 3. 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 3 Genetic design
  4. 4. Life cycle of HIV
  5. 5. Pathophysiology 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 5 - HIV attaches to T-cells & monocytes/macrophages - CD4 cell count ↓ --- immunodeficiency --- opportunistic infections - Macrophages --- ↓ migration response to chemoattractants -- defective intracellular killing of organisms - Impaired Ag presentation - Excessive production of TNF α --- dementia, wasting, unexplained fever
  6. 6. Diagnostic tests 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 6
  7. 7. 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 7 Revised WHO clinical staging of HIV/AIDS for adults and adolescents
  8. 8. Prevalence People living with HIV/AIDS in 2014 36.9 million Women living with HIV/AIDS in 2014 51% Children living with HIV/AIDS in 2014 2.6 million People newly infected with HIV in 2015 2.0 million Children newly infected with HIV in 2014 2.2 lacs AIDS deaths in 2014 1.2 million Child AIDS deaths in 2014 1.5 lacs 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 8 Leading cause of death HIV + TB  leading cause of death in 2013 (13% of new TB + HIV) The Global HIV/AIDS Epidemic Jul 31, 2015
  9. 9. Status of HIV epidemic in India ◦ 2.4 million (Adult prevalence -- 0.31%) • 1986: 1st case detected in Chennai • 1990: HIV/AIDS Cell set up by MoHFW • 1992: NACP-I launched • 1992: National AIDS Control Organisation (NACO) • 1999-2006: NACP-II launched • 2007-2012: NACP-III launched • NACP IV (2012-2017) 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 9
  10. 10. Declining Trends of HIV Epidemic in India 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 10 22.5 21.9 21.4 21.1 20.9 0.33 0.31 0.30 0.28 0.27 0.00 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.0 5.0 10.0 15.0 20.0 25.0 2007 2008 2009 2010 2011 AdultHIVPrevalence(%) NumberofPLHIV(Lakhs) Estimated Adult HIV Prevalence & Number of PLHIV, India, 2007-11 Number of PLHA (Lakhs) Adult HIV Prevalence (%) Female: 39%; Children: 7% Technical Report India HIV Estimates 2012, NACO & NIMS
  11. 11. Classification of Antiretroviral Drugs 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 11
  12. 12. Guidelines for starting ART ◦ All symptomatic patients ◦ Asymptomatic patients with CD4 count < 350/μl ◦ All HIV patients co-infected with HBV/HCV ◦ All pregnant HIV positive women ◦ All patients with HIV nephropathy PLUS NACO guidelines: ◦ All HIV patients with WHO clinical stage 3-4 ◦ All patients tested HIV positive 6-8 years ago ◦ History of TB/or Herpes ◦ HIV infected partners of AIDS patients ◦ All HIV positive children < 15years 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 12
  13. 13. HAART ◦ Highly Active Anti-Retroviral Therapy (1995) ◦ 3 ART (1 NRTI + 1 NNRTI + 1 PI with ritonavir or 2 NRTI + 1 PI with ritonavir) Goals: ◦ Achieve virologic suppression (viral load < 50 copies/ml) ◦ Reverse decline in CD4 count ◦ Reconstitute & preserve immunologic function (↓ opportunistic infections) ◦ Improve quality of life 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 13
  14. 14. First line NACO recommended 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 14 Preferred regimen Lamivudine + Zidovudine + Nevirapine Alternative regimens Lamivudine + Zidovudine + Efavirenz Lamivudine + Stavudine + Efavirenz Lamivudine + Stavudine + Nevirapine Others Lamivudine + Tenofovir + Nevirapine Lamivudine + Tenofovir + Efavirenz Lamivudine + Zidovudine + Tenofovir Second line regimens NRTI PI Standard regimens Tenofovir + Abacavir Lopinavir Didanosine + Abacavir Atazanavir Tenofovir + Zidovudine Saquinavir Tenofovir + Lamivudine Indinavir Nelfinavir Special circumstances Didanosine + Zidovudine Didanosine + Lamivudine
  15. 15. 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 15 The Value of Innovation in HIV/AIDS Therapy, Boston healthcare, Sept. 2014
  16. 16. NRTIs (Nucleoside reverse transcriptase inhibitors) ◦ Prevent infection of susceptible cells ◦ Phosphorylation ◦ Lack 3’ hydroxyl group ◦ Competitive inhibition ◦ Renal excretion (except AZT & ABC) ◦ ADR: Bone marrow suppression, GI intolerance, fatigue, headache, anorexia, insomnia, lactic acidosis, hepatic & renal toxicity, myopathy, pancreatitis, peripheral neuropathy ◦ Inhibit human DNA polymerase γ ◦ Less drug interactions 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 16
  17. 17. Zidovudine (AZT/ZVD) – 1st ART approved in 1987 --- BM suppression (anemia/neutropenia), pigmentation of nails Stavudine (d4T) -- hepatic steatosis, lipodystrophy Didanosine (ddI) -- optic neuritis, pancreatitis, hyperuricemia Zalcitabine (DDC) – diarrhea, stomatitis, oesophageal ulceration (Production stopped in 2006) Lamivudine (3TC) – Least toxic, well tolerated Emtricitabine (FTC) -- hyperpigmentation of skin Tenofovir (TDF) -- Nucleotide analogue, Available as tenofovir disoproxil fumarate (prodrug), Well tolerated, Flatulence (OATP drug transporter) Abacavir (ABC) -- Fatal hypersensitivity syndrome, genetic (release of TNFα) --- Onset 1-6 weeks (2- 9%), ↑ MI episodes (alcohol dehyrogenase) Combivir -- AZT+3TC Trizivir -- AZT+3TC+ ABC 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 20
  18. 18. NNRTIs (Non Nucleoside reverse transcriptase inhibitors) ◦ Potent, highly effective ◦ Active against HIV-1 ◦ Non-competitive inhibition ◦ Do not require phosphorylation ◦ No activity against host DNA polymerase ◦ Hepatic metabolism ◦ ADR: Hepatotoxic, rash, GI intolerance, fever, headache, fatigue, somnolence ◦ Fatal: Steven’s Johnson Syndrome ◦ Long term use: fat accumulation 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 21
  19. 19. Nevirapine (NVP) – Maculopapular rash (1st 6 weeks), fulminant hepatitis (↑ incidence in women with CD4 count >250), Steven’s Johnson Syndrome…extended release tablets available Efavirenz (EFV) – teratogenic, morbiliform rash, neuropsychiatric symptoms (seen with 1st dose) Delavirdine (DLV) – neutropenia (not used) Etravirine (ETV) – Newer agent (CYP3A4 inducer, CYP2C9 & CYP2C19 inhibitor) Rilpivirine – Newer agent for HIV-1, Only for treatment naïve patients. Depression, headache, insomnia, QTc prolongation 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 24
  20. 20. PIs (Protease inhibitors) ◦ Peptide-like ◦ Competitively inhibit viral aspartyl protease ◦ High inter-individual variability ◦ Highly plasma protein bound ◦ P-glycoprotein substrate, OATP drug transporter ◦ CYP3A4 (except Nelfinavir) ◦ Potential for drug interactions ◦ ADR: GI intolerance, rash, paresthesia ◦ Long term use: lipodystrophy & insulin resistance, ↑ TGs, ↑ cholesterol 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 25
  21. 21. “Boosted Ritonavir” ◦ Potent CYP3A4 inhibitor ◦ Inhibits 1st pass & systemic clearance ◦ ↑ bioavailabilty (longer T1/2) ◦ Reduces dose & frequency ◦ Overcomes deleterious effects of food on Indinavir ◦ Cannot be combined with nelfinavir 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 28
  22. 22. ◦ Saquinavir (SQV) -- 1st PI (1995) -- Available as hard gel capsules ◦ Indinavir (IDV) -- Crystalluria, nephrolithiasis, alopecia, metallic taste, hemolytic anemia • Nelfinavir (NFV) -- CYP2C19 (Only PI not boosted by ritonavir), Safe in pregnancy ◦ Ritonavir (RTV) – bitter taste ◦ Lopinavir (LPV) -- Only PI FDC (4:1) ◦ Atazanavir (ATV) -- unconjugated hyperbilirubinemia (inhibits hepatic glucuronyl transferase), ↑ PR interval (1st degree heart block), ↑ bleeding episodes in hemophilics ◦ Fosamprenavir (FPV) – Prodrug, better tolerated ◦ Darunavir (DRV) -- Use only in treatment experienced patients (newer) ◦ Tipranavir (TPV) -- intracranial hemorrhages; Use only in treatment experienced patients (newer) 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 29
  23. 23. Entry inhibitors Enfuvirtide
  24. 24. Enfuvirtide (T-20) -- 2003 ◦ Subcutaneous injection BD ◦ Synthetic polypeptide, binds to gp41 subunit of HIV-1 (fusion inhibitor) ◦ 84% bioavailability, 98% plasma protein bound ◦ Only in treatment experienced ◦ ADR: Local injection site reactions, rash, eosinophilia, ↑ risk of bacterial pneumonia, hypersensitivity (fatal) Maraviroc (MVC) – 2007 CCR5 antagonist blocks binding of HIV outer envelope protein gp120 to CCR5 chemokine receptor ◦ Bioavailability 30%, 76% plasma protein bound, CYP3A4 ◦ Treatment experienced CCR5-tropic MDR-HIV-1 strains ◦ ADR: Cough, fever, rash, abdominal pain, rhinitis, dizziness, sleep disorder ◦ Serious events (< 2%): hepatic failure, viral meningitis, osteonecrosis, rhabdomyelitis ◦ Lab abnormalities: ↑ bilirubin, amylase/lipase, AST/ALT 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 31 Entry inhibitors
  25. 25. Integrase inhibitors Raltegravir (RAL) -- 2011 ◦ Blocks catalytic activity of integrase  prevent insertion of HIV genetic material into host genome ◦ Biphasic elimination, Glucuroidation (UGT1A1) ◦ 83% plasma protein bound ◦ Antacids & iron bind to integrase (2 hrs dose interval) ◦ Adverse Events: GI intolerance, fever, headache, creatine kinase elevation (myopathy, rhabdomyolysis), exacerbation of depression ◦ Treatment experienced patients 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 32
  26. 26. Elvitegravir (2012) ◦ Available only as FDC (cobicistat, emtricitabine, tenofovir)  requires boosting cobicistat (PK enhancer, inhibits CYP3A4 & intestinal transport proteins) or ritonavir ◦ C/I in renal disorder Dolutegravir (2013) ◦ Retains activity against virus resistant to raltegravir & elvitegravir for HIV-1 ◦ UGT1A1 & CYP3A ◦ Inhibits renal organic cation transporter (OCT2) ◦ > 12yrs 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 33
  27. 27. Maturation Inhibitors Bevirimat (Phase III) ◦ Semisynthetic derivative of Chinese herb (syzigium claviflorum) ◦ Inhibits viral maturation – released viruses cannot infect other host cells ◦ Well tolerated (nausea, headache) ◦ Glucuronidation ◦ Cross resistance with PI 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 35
  28. 28. Azithromycin “Off-label” ◦ Prevent: Disseminated MAC  primary & secondary prophylaxis, syphilis ◦ Treat: toxoplasmosis, MAC, bacterial enteric infections (campylobacteriosis, shigellosis), bacteremia, osteomyelitis, syphilis Foscarnet ◦ Inhibits HIV reverse transcriptase ◦ In resistant cases, markedly ↓ plasma HIV load & improves immunological status ◦ Foscarnet induction therapy – 5 g iv BD for 6 weeks + antiretroviral regimen Hydroxyurea ◦ 1st ART targeting cellular factor (novel, inexpensive HIV combination therapy) ◦ Resistance resistant (impedes resistance to NRTIs) ◦ Cytostatic, immunomodulatory effects -- reduce activated HIV target cells (long-term treatment) ◦ Hydroxyurea-based regimens  Effective, potent (sustained viral suppresion), well tolerated in primary & chronic HIV 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 36
  29. 29. Post Exposure Prophylaxis (PEP) ◦ Initiate as soon as possible ◦ 2 drug regime (low risk): 3TC (150 mg) + AZT (300 mg) BD for 4 weeks ◦ Expanded 3 drug regime (high risk): Above + IDV/r 800 mg TDS* 4 weeks ◦ Serology: 0, 6, 12 weeks, 6, 12 months 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 37
  30. 30. Pregnancy ◦ 2nd trimester ◦ AZT (300 mg) + 3TC (150 mg) + NFV (1250 mg) BD ◦ Efavirenz – teratogenic ◦ Nevirapine - ↑ hepatotoxicity in CD4 > 250 Perinatal prophylaxis ◦ Intra-partum: AZT 2 mg/kg; 1 mg/kg/hr until delivery ◦ Post-partum: (Infant) AZT syrup 2 mg/kg QID or 1.5 mg/kg IV QID for 6 weeks ◦ Single dose of NVP (200 mg) --- onset of delivery + neonate within 1st 3 days (2 mg/kg) 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 38 Pocket Guide Adult HIV/AIDS Treatment January 2006
  31. 31. Hepatitis Co-infection HBV ◦ Tenofovir, Lamivudine (LMV), Emtricitabine (FTC) ◦ Hepatocellular inflammation “Flares”  LMV or FTC + entecavir ◦ In early HIV, treat HBV only: adefovir/entecavir HCV ◦ ART excluding didanosine with ribavirin 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 39
  32. 32. Opportunistic infections 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 40 TB (latent) > 5mm INH 300 mg//day + pyridoxine 50 mg/day PCP CD4 < 200/mm3 or CD4% <14, oral thrush TMP-SMX 1 tab/day Toxoplasmosis CD4 < 100/mm3 + anti-Tox IgG TMP-SMX 1 tab/day MAC CD4 < 50/mm3 Azithromycin 1200 mg/wk Clarithromycin 500 mg BD Varicella Exposure to chickenpox/zoster VZIG 6.25 mL IM < 96 hr
  33. 33. 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 41
  34. 34. Pneumocystis carinii pneumonia Acute therapy ◦ TMP-SMX 15-20 mg/kg/day IV for 21 days Chronic maintenance therapy ◦ TMP-SMX ◦ Alternative: Dapsone 100 mg/day ◦ Dapsone 50 mg/day + pyrimethamine 50 mg + leucovorin 25 mg/wk ◦ Dapsone 200 mg + pyremethamine 75 mg + leucovorin 25 mg/wk ◦ Pentamidine aerosol 300 mg/month ◦ Atovaquone 1500 mg/day 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 42 Toxoplasma gondii Encephalitis Acute therapy: Pyrimethamine 200 mg, then 50 mg (< 60 kg)/day + sulfadiazine 1,000 (<60 kg) QID + leucovorin 10-20 mg/day
  35. 35. Disseminated Mycobacterium Avium Complex Disease (MAC) At least 2 drugs as initial therapy ◦ Clarithromycin 500 mg BD + Ethionamide 15 mg/kg/day ◦ Consider adding a 3rd agent (CD4 < 50, high mycobacterial load, absence of ART); Rifabutin 300 mg/day ◦ Chronic maintenance therapy ◦ Clarithromycin 500 mg BD + Ethionamide 15 mg/kg/day +/- Rifabutin 300 mg/day lifelong until sustained immunity Cryptosporidiosis Acute therapy ◦ Amphotericin B 0.7 mg/kg/day IV + Flucytosine 25 mg/kg QID for 2 weeks followed by fluconazole 400 mg/day for 8 weeks/until CSF sterile ◦ Chronic maintenance therapy ◦ Fluconazole 200 mg/day 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 43
  36. 36. Immune Reconstitution Inflammatory Syndrome (IRIS) ◦ Initiation therapy with low CD4 or advancing disease ◦ Associated with better virological response to therapy Paradoxical worsening ◦ Onset: <1 week to years ◦ Incidence: 10-25% ◦ Implicating pathogens: TB, other mycobacterial diseases, cryptococcosis, HBV, HCV, Pneumocystis pneumonia ◦ Symptomatic relief ◦ Defer ART 1-3 weeks (depending on CD4 count) 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 44 CID 2004;38:1159-66
  37. 37. Salvage Therapy ◦ Treatment interruptions ◦ Multi-drug Rescue ◦ Drug selection based on past exposure & resistance, treatment failure ◦ Foscarnet induction ◦ Mega-HAART ◦ Typically 5-9 drugs ◦ Boosted PI ◦ 1-2 NNRTIs ◦ Several NRTIs ◦ Hydroxyurea ◦ Adherence > 95% required 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 45 3rd International Workshop on Salvage Therapy for HIV infection HIV/AIDS eJournal 6(3),2000
  38. 38. Investigational Agents NRTIs ◦ Apricitabine ◦ KP-1461 ◦ Stampidine ◦ Racivir ◦ Fozivudine tidoxil NNRTIs ◦ Elvucitabine (Phase III) ◦ Capravirine (Phase II) ◦ Lersivirine 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 46 aidsinfo.nih.gov Entry Inhibitors ◦ Vicriviroc (Phase III) ◦ Cicriviroc ◦ Apraviroc (Banned) ◦ AMDO70 ◦ PRO 140 ◦ Peptide T ◦ Ibalizumab ◦ BMS-488043 ◦ PRO 542 Integrase Inhibitors – GS 9137
  39. 39. Recent advances ◦ Gene modification ◦ Tesamorelin (INN) -- synthetic GHRH, used in HIV-associated lipodystrophy (↓ excess abdominal fat) ◦ Portmanteau inhibitor -- combination of 2 drugs, each being type of inhibitor (reverse transcriptase inhibitor + integrase inhibitor) & (integrase inhibitor + CCR5 entry inhibitor– 2011) ◦ Vaccines -- Viral gp120--RV 144 (Phase I/II), Live vector viruses– Adeno V520 (Phase II), pure gp120 protein + killed canary pox (Phase II) ◦ Vaginal rings (contraception + anti- HIV property) ◦ 1% Tenofovir vaginal gels (↓ risk of HSV-2 -----↓ risk of HIV) ◦ Pre-exposure prophylaxis (PrEP) -- FDC tenofovir disoproxil fumarate 300 mg + emtricitabine 200 mg (High risk) ◦ Combination pills Tenof-EM -- FTC + TDF (1 tablet OD) Trustiva -- EFV + FTC + TDF (1st 3-drug combination – July 2006) (1 tablet OD) 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 48
  40. 40. Crofelemer - Oral proanthocyanidine oligomer  relieves symptoms of diarrhea in HIV/AIDS in patients on ART. - It acts by voltage independently blocking 2 structurally unrelated chloride channels in the gut (CFTR – cystic fibrosis transmembrane conductance regulator) and calcium activated channel anoctamin 1. - Inhibition  few chloride ions excreted in gut  ↓ Na & H2O  improve stool consistency  ↓ duration of diarrhoea - Not absorbed in the gut……excreted with stool. Somatrem and Somatropin - Recombinant growth hormone for AIDS related wasting 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 49
  41. 41. India’s AIDS programme disintegrating? ◦ NACP-IV (2012-17)--- World Bank funded $250 million ◦ Supply of antiretroviral drugs, erratic since December 2013. Without replenishments, stocks depleted rapidly in 2014, eventually resulting in empty shelves from January. Over last 9 months, every ART centre in country has run out of at least 1 drug for several weeks. (Feb 2015) http://www.livemint.com/Politics/n2svOmWwLqMsZuViMKwHmJ/IsIndiasAIDSprogrammedisintegrating 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 51
  42. 42. Is HIV curable? ◦ Homozygous CCR5 allele  inactive CCR5 gene product --- high resistance against HIV1 ◦ In 40 year patient with AML (1998), allogeneic stem cell transplantation from HLA matched donor --- complete chimerism -- non–CCR5tropic variant ---- discontinuation of HAART ≥ 20 months, HIV1 virus remained undetected ◦ Central role of CCR5 receptor during HIV1 infection & disease progression 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 52 Long Term Control of HIV by CCR5 Delta32/Delta32 Stem Cell Transplantation — NEJM
  43. 43. ◦ Mississippi baby (2010) – HIV at birth from HIV-positive mother, In 2013 thought to be cured of HIV -------- July 10, 2014 ◦ Timothy Ray Brown, The Berlin patient, first and only person 'cured' of HIV- --stem cell transplant from a donor naturally resistant, off antiretroviral therapy since 1st day of his stem cell transplant (2008) 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 53 nejm.org february 13, 2014
  44. 44. 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 54
  45. 45. References ◦ Goodman Gillman 12th edition ◦ Katzung 13th edition ◦ Rang and Dale 7th edition ◦ KD Tripathi 7th editon ◦ KK Sharma 2nd edition ◦ NACO Annual Report 2014-15 (www.naco.gov.in) ◦ WHO-UNAIDS Report 2014-15. (www.unaids.org) ◦ Interim who clinical staging of hiv/aids and hiv/aids case definitions for surveillance. ◦ http://aidsinfo.nih.gov/guidelines on 9/14/2015 16-09-2015 MIMER Medical College Talegaon Department of Pharmacology 55

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