natgillin/translations-raw huggingface dataset:
7 Samtidig brug anbefales ikke:
Concomitant use not recommended:
Viread bør ikke tages sammen med andre lægemidler, der indeholder tenofovirdisoproxilfumarat (Truvada eller Atripla).
Viread should not be administered with any other medicinal products containing tenofovir disoproxil fumarate (Truvada or Atripla).
Viread bør heller ikke tages samtidig med adefovirdipivoxil.
Viread should also not be administered concurrently with adefovir dipivoxil.
4. 4 og tabel 1).
Co-administration of tenofovir disoproxil fumarate and didanosine is not recommended (see section 4.4 and Table 1).
Lægemidler, som udskilles gennem nyrerne:
7 Renally eliminated medicinal products:
Da tenofovir primært udskilles gennem nyrerne, kan administration af tenofovirdisoproxilfumarat samtidig med lægemidler, der reducerer nyrefunktionen eller konkurrerer om aktiv tubulær secernering via transportproteinerne hOAT 1, hOAT 3 eller MRP 4 (f. eks. cidofovir), øge serumkoncentrationerne af tenofovir og/ eller de samtidigt administrerede lægemidler.
Since tenofovir is primarily eliminated by the kidneys, co-administration of tenofovir disoproxil fumarate with medicinal products that reduce renal function or compete for active tubular secretion via transport proteins hOAT 1, hOAT 3 or MRP 4 (e. g. cidofovir) may increase serum concentrations of tenofovir and/ or the co-administered medicinal products.
Da tacrolimus kan påvirke nyrefunktionen, anbefales nøje overvågning, når det administreres samtidigt med tenofovirdisoproxilfumarat.
Given that tacrolimus can affect renal function, close monitoring is recommended when it is co-administered with tenofovir disoproxil fumarate.
Andre interaktioner Interaktioner mellem tenofovirdisoproxilfumarat og proteasehæmmere samt andre antiretrovirale lægemidler end proteasehæmmere ses i tabel 1 nedenfor (stigning er angivet som "↑", fald som "↓", ingen ændring som "↔", to gange dagligt som "b. i. d.", en gang dagligt som "q. d.").
Interactions between tenofovir disoproxil fumarate and protease inhibitors and antiretroviral agents other than protease inhibitors are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ b. i. d.”, and once daily as “ q. d.”).
Interaktioner mellem tenofovirdisoproxilfumarat og andre lægemidler
Interactions between tenofovir disoproxil fumarate and other medicinal products
Lægemiddel iht. terapeutisk
Medicinal product by
Anbefaling vedr. samtidig
Recommendation
område
therapeutic areas
Gennemsnitlig ændring (%) i AUC,
Mean percent change in AUC, Cmax, Cmin
administration af
concerning
(dosis i mg)
(dose in mg)
tenofovirdisoproxilfumarat 300 mg
co-administration with tenofovir disoproxil fumarate 300 mg
ANTIINFEKTIVA Antiretrovirale lægemidler Proteasehæmmere Atazanavir/ ritonavir (300 q. d. / 100 q. d. / 300 q. d.)
ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/ Ritonavir (300 q. d. / 100 q. d. / 300 q. d.)
Den forøgede tenofovir- eksponering kan forstærke effekten af bivirkninger ved tenofovir, herunder nyresygdomme.
The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
4. 4).
Renal function should be closely monitored (see section 4.4).
Lopinavir/ ritonavir (400 b. i. d. / 100 b. i. d. / 300 q. d.)
Lopinavir/ Ritonavir (400 b. i. d. / 100 b. i. d. / 300 q. d.)
Ingen signifikant virkning på de farmakokinetiske parametre for lopinavir/ ritonavir.
No significant effect on lopinavir/ ritonavir PK parameters.
8 Darunavir/ ritonavir (300/ 100 b. i. d. / 300 q. d.) NRTIer
Darunavir/ Ritonavir (300/ 100 b. i. d. / 300 q. d.) NRTIs
Ingen signifikant virkning på de farmakokinetiske parametre for darunavir/ ritonavir.
No significant effect on darunavir/ ritonavir PK parameters.
Nyrefunktionen skal overvåges nøje (se pkt.
Renal function should be closely monitored (see section 4.4).
4. 4).
Didanosine
Didanosin
Co-administration of
Samtidig indgivelse af tenofovirdisoproxilfumarat og didanosin resulterer i en 40- 60% stigning i systemisk eksponering over for didanosin, hvilket kan øge risikoen for didanosinrelaterede bivirkninger.
fumarate and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse events.
En reduceret dosis på 250 mg didanosin, der administreres samtidig med tenofovirdisoproxilfumarat er blevet sat i forbindelse med rapporter om høj forekomst af manglende virologisk effekt i flere testede kombinationer til behandling af HIV- 1- infektion.
A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil fumarate therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
4. 4).
tenofovir disoproxil fumarate and didanosine is not recommended (see section 4.4).
4. 4).
Tenofovir disoproxil fumarate should not be administered concurrently with adefovir dipivoxil (see section 4.4).
Undersøgelser, der blev udført med andre lægemidler:
Studies conducted with other medicinal products:
Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovirdisoproxilfumarat blev administreret sammen med emtricitabin, lamivudin, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), metadon, ribavirin, rifampicin, tacrolimus eller hormonantikonceptionsmidlet norgestimat/ ethinylestradiol.
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ ethinyl oestradiol.
5. 2).
Tenofovir disoproxil fumarate must be taken with food, as food enhances the bioavailability of tenofovir (see section 5.2).
Graviditet Der foreligger begrænsede kliniske data om eksponering for tenofovirdisoproxilfumarat under graviditet.
Pregnancy For tenofovir disoproxil fumarate limited clinical data on exposed pregnancies are available.
5. 3).
Animal studies do not indicate direct or indirect harmful effects of tenofovir disoproxil fumarate with respect to pregnancy, foetal development, parturition or postnatal development (see section 5.3).
9 Tenofovirdisoproxilfumarat må kun anvendes under graviditet, hvis den potentielle gavnlige effekt opvejer den potentielle risiko for fosteret.
Tenofovir disoproxil fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Fordi de potentielle risici for menneskefostre under udvikling er ukendte, skal anvendelse af tenofovirdisoproxilfumarat til kvinder i den fødedygtige alder ledsages af brug af effektiv antikonception.
Given that the potential risks to developing human foetuses are unknown, the use of tenofovir disoproxil fumarate in women of childbearing potential must be accompanied by the use of effective contraception.
Amning I dyreforsøg er det blevet påvist, at tenofovir udskilles i mælk.
Lactation In animal studies it has been shown that tenofovir is excreted into milk.
Det vides ikke, om tenofovir udskilles i human modermælk.
It is not known whether tenofovir is excreted in human milk.
Det anbefales derfor, at mødre, som behandles med tenofovirdisoproxilfumarat, ikke ammer deres børn.
Therefore, it is recommended that mothers being treated with tenofovir disoproxil fumarate do not breast-feed their infants.
For at undgå overførsel af HIV og HBV til spædbørn anbefales det som regel, at HIV - og HBV- inficerede kvinder ikke ammer deres børn.
9 As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant.
Vurderingen af uønskede hændelser med data fra kliniske undersøgelser baseres på erfaringer fra to undersøgelser, hvor 653 behandlingserfarne patienter fik behandling med tenofovirdisoproxilfumarat (n = 443) eller placebo (n = 210) i kombination med andre antiretrovirale lægemidler i 24 uger og også i en dobbeltblind sammenlignende kontrolleret undersøgelse, hvori 600 behandlingsnaive patienter fik behandling med tenofovirdisoproxil 245 mg (som fumarat) (n = 299) eller stavudin (n = 301) i kombination med lamivudin og efavirenz i 144 uger.
Assessment of adverse reactions from clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil fumarate (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve patients received treatment with tenofovir disoproxil 245 mg (as fumarate) (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
1/ 3 af patienter kan forventes at få uønskede reaktioner efter behandling med tenofovirdisoproxilfumarat i kombination med andre antiretrovirale midler.
Approximately one third of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil fumarate in combination with other antiretroviral agents.
Disse reaktioner er som regel milde til moderate gastrointestinale symptomer.
These reactions are usually mild to moderate gastrointestinal events.
De uønskede reaktioner med mistænkt (eller i det mindste en mulig) forbindelse med behandling er anført nedenfor efter systemorganklasse og absolut frekvens.
The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and absolute frequency.
Frekvenser er defineret som meget almindelig (≥ 1/ 10) eller almindelig (≥ 1/ 100, < 1/ 10).
Frequencies are defined as very common (≥ 1/ 10) or common (≥ 1/ 100, < 1/ 10).
Se også Erfaringer efter markedsføring nedenfor.
See also Post-marketing experience below.
Meget almindelig: hypofosfatæmia
Very common: hypophosphataemia
Meget almindelig: svimmelhed
Very common: dizziness
Meget almindelig: diarré, opkastning, kvalme Almindelig: flatulens
Very common: diarrhoea, vomiting, nausea Common: flatulence
1% af de tenofovirdisoproxilfumarat- behandlede patienter ophørte med behandlingen på grund af de gastrointestinale symptomer.
Approximately 1% of tenofovir disoproxil fumarate-treated patients discontinued treatment due to the gastrointestinal events.
10 Antiretroviral kombinationsbehandling er hos HIV- patienter associeret med omfordeling af kropsfedt (lipodystrophia) herunder tab af subkutant fedt perifert og i ansigtet, øget intraabdominalt og visceralt fedt, brysthypertrofi og dorsocervical fedtophobning ("buffalo hump").
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
I en 144- ugers kontrolleret, klinisk undersøgelse, som sammenlignede tenofovirdisoproxilfumarat med stavudin i kombination med lamivudin og efavirenz hos antiretroviral- naive patienter, havde patienter, som fik tenofovirdisoproxil signifikant lavere forekomst af lipodystrophia sammenlignet med patienter, som fik stavudin.
In a 144-week controlled clinical study in antiretroviral-naïve patients that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz, patients who received tenofovir disoproxil had a significantly lower incidence of lipodystrophy compared with patients who received stavudine.
Tenofovirdisoproxilfumarat- armen havde også en signifikant lavere gennemsnitlig stigning i fastende triglycerider og total kolesterol i forhold til sammenligningsarmen.
The tenofovir disoproxil fumarate arm also had significantly smaller mean increases in fasting triglycerides and total cholesterol than the comparator arm.
Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden HIV- sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART) er der rapporteret om tilfælde af osteonekrose.
10 Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Hepatitis B:
Hepatitis B:
Vurderingen af uønskede reaktioner med data fra kliniske undersøgelser baseres på erfaringer fra to dobbeltblinde, sammenlignende, kontrollerede undersøgelser, hvor 641 patienter med kronisk hepatitis B og kompenseret leversygdom blev behandlet med tenofovirdisoproxil 245 mg (som fumarat) dagligt (n = 426) eller adefovirdipivoxil 10 mg dagligt (n = 215) i 48 uger.
Assessment of adverse reactions from clinical study data is based on experience in two double-blind comparative controlled studies in which 641 patients with chronic hepatitis B and compensated liver disease received treatment with tenofovir disoproxil 245 mg (as fumarate) daily (n = 426) or adefovir dipivoxil 10 mg daily (n = 215) for 48 weeks.
De uønskede reaktioner med mistænkt (eller i det mindste en mulig) forbindelse med behandlingen er anført nedenfor efter systemorganklasse og frekvens.
The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and frequency.
Frekvenser er defineret som almindelig (≥ 1/ 100, < 1/ 10).
Frequencies are defined as common (≥ 1/ 100, < 1/ 10).
Almindelig: hovedpine
Common: headache
Almindelig: diarré, opkastning, mavesmerter, kvalme, abdominal distension, flatulens
Common: diarrhoea, vomiting, abdominal pain, nausea, abdominal distension, flatulence
ALAT- stigning
ALT increase
Forværring under behandlingen:
Exacerbations during treatment:
I undersøgelser med nukleosid- naive patienter forekom der efter behandlingsstart stigninger i ALAT > 10 gange ULN (øvre grænse af normalværdien) og > 2 gange baseline hos 2, 6% af de tenofovirdisoproxilfumarat- behandlede patienter versus 1, 9% af de adefovirdipivoxil- behandlede patienter.
In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil fumarate-treated patients versus 1.9% of adefovir dipivoxil-treated patients.
Disse stigninger forsvandt ved fortsat behandling og var i de fleste tilfælde associeret med en reduktion i virusmængden på ≥ 2 log10 kopier/ ml, som gik forud for eller faldt sammen med ALAT- stigningen.
Among tenofovir disoproxil fumarate-treated patients, on-treatment ALT elevations had a median time to onset of 8 weeks, resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10 copies/ ml reduction in viral load that preceded or coincided with the ALT elevation.
Der anbefales periodisk overvågning af leverfunktionen under behandling.
Periodic monitoring of hepatic function is recommended during treatment.
Erfaringer efter markedsføring:
Post-marketing experience:
Udover de rapporterede, uønskede hændelser fra kliniske undersøgelser er de følgende bivirkninger også blevet identificeret i løbet af sikkerhedsovervågningen af tenofovirdisoproxilfumarat efter markedsføringen.
In addition to adverse reaction reports from clinical studies the following possible adverse reactions have also been identified during post-marketing safety surveillance of tenofovir disoproxil fumarate.
Frekvenser er defineret som sjældne (≥ 1/ 10. 000, < 1/ 1. 000) eller meget sjældne (< 1/ 10. 000), herunder enkeltstående indberetninger.
Frequencies are defined as rare (≥ 1/ 10,000, < 1/ 1,000) or very rare (< 1/ 10,000) including isolated reports.
Da disse hændelser blev frivilligt indberettet af en population med ukendt størrelse, kan der ikke altid foretages frekvensvurderinger.
Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot always be made.
Sjælden: laktatacidose
Rare: lactic acidosis Not known: hypokalaemia
Sjælden: pancreatitis
Rare: pancreatitis
Sjælden: forhøjede transaminaser Meget sjælden: hepatitis Ikke kendt: steatosis hepatis
Rare: increased transaminases Very rare: hepatitis Not known: hepatic steatosis
Sjælden: udslæt
Rare: rash
Knogler, led, muskler og bindevæv:
11 Musculoskeletal and connective tissue disorders:
Ikke kendt: rabdomyolyse, osteomalaci (manifesteret som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer), muskelsvækkelse, myopati
Not known: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), muscular weakness, myopathy
Sjælden: akut nyresvigt, nyresvigt, proksimal renal tubulopati (herunder Fanconis syndrom), øget kreatinin Meget sjælden: akut tubulær nekrose Ikke kendt: nefritis (inklusive akut interstitiel nefritis), nefrogen diabetes insipidus
Rare: acute renal failure, renal failure, proximal renal tubulopathy (including Fanconi syndrome), increased creatinine Very rare: acute tubular necrosis Not known: nephritis (including acute interstitial nephritis), nephrogenic diabetes insipidus
Meget sjælden: asteni
Very rare: asthenia
Følgende, uønskede reaktioner, som er opført under systemorganklasserne ovenfor, kan forekomme som en følge af proksimal renal tubulopati: rabdomyolyse, osteomalaci (manifesteret som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer), hypokalæmi, muskelsvækkelse, myopati og hypofosfatæmi.
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), hypokalaemia, muscular weakness, myopathy and hypophosphataemia.
4. 8 og 5. 3), og der skal gives støttende standardbehandling efter behov.
If overdose occurs the patient must be monitored for evidence of toxicity (see sections 4.8 and 5.3), and standard supportive treatment applied as necessary.
Tenofovir kan fjernes ved hæmodialyse; median hæmodialyse- clearance af tenofovir er 134 ml/ min.
Tenofovir can be removed by haemodialysis; the median haemodialysis clearance of tenofovir is 134 ml/ min.
Eliminationen af tenofovir ved peritonealdialyse er ikke blevet undersøgt.
The elimination of tenofovir by peritoneal dialysis has not been studied.
Tenofovirdisoproxil absorberes og omdannes til det aktive stof tenofovir, som er en nukleosidmonofosfat (nukleotid) - analog.
Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue.
Tenofovirdiphosphat har en intracellulær halveringstid på 10 timer i aktiverede og 50 timer i hvilende mononukleære celler i perifert blod (peripheral blood mononuclear cells, PBMC' er).
Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs).
12 Tenofovirdiphosphat hæmmer HIV- 1- reverse- transkriptase og HBV- polymerase ved direkte bindingskonkurrence med det naturlige deoxyribonukleotidsubstrat og - efter indføjelse i DNA - ved DNA- kædeblokering.
Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.
Ved koncentrationer på op til 300 µmol/ l har tenofovir tilmed ikke vist effekt på syntesen af mitokondrie- DNA eller produktionen af mælkesyre ved in vitro- analyser.
At concentrations of up to 300 µmol/ l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays.
Data vedrørende HIV:
Data pertaining to HIV:
HIV- antiviral aktivitet in vitro:
HIV antiviral activity in vitro:
Den koncentration af tenofovir, der kræves til 50% hæmning (EC50) af laboratorie- vildtypestammen HIV- 1IIIB, er 1- 6 µmol/ l ved lymfoide cellelinier og 1, 1 µmol/ l mod primære HIV- 1 subtype B isolater i PBMC' er.
The concentration of tenofovir required for 50% inhibition (EC50) of the wild-type laboratory strain HIV-1IIIB is 1-6 µmol/ l in lymphoid cell lines and 1.1 µmol/ l against primary HIV-1 subtype B isolates in PBMCs.
Tenofovir er også aktivt mod HIV- 1- subtyperne A, C, D, E, F, G og O og mod HIVBaL ved primære monocyt - / makrofagceller.
Tenofovir is also active against HIV-1 subtypes A, C, D, E, F, G, and O and against HIVBaL in primary monocyte/ macrophage cells.
Tenofovir er desuden aktivt in vitro mod HIV- 2 med en EC50 på 4, 9 µmol/ l ved MT- 4- celler.
Tenofovir shows activity in vitro against HIV-2, with an EC50 of 4.9 µmol/ l in MT-4 cells.
Stammer af HIV- 1 med nedsat følsomhed over for tenofovir og en K65R- mutation ved reverse transkriptase er blevet udsøgt in vitro og hos nogle patienter (se Kliniske resultater).
Strains of HIV-1 with reduced susceptibility to tenofovir and a K65R mutation in reverse transcriptase have been selected in vitro and in some patients (see Clinical results).
4. 4).
Tenofovir 12 disoproxil fumarate should be avoided in antiretroviral experienced patients with strains harbouring the K65R mutation (see section 4.4).
Kliniske undersøgelser af tidligere behandlede patienter har vurderet anti- HIV- aktiviteten af tenofovirdisoproxil 245 mg (som fumarat) mod HIV- 1- stammer med resistens over for nukleosidhæmmere.
Clinical studies in treatment-experienced patients have assessed the anti-HIV activity of tenofovir disoproxil 245 mg (as fumarate) against strains of HIV-1 with resistance to nucleoside inhibitors.
Resultaterne indikerer, at patienter, hvis HIV udtrykte 3 eller flere thymidin - analog- forbundne mutationer (TAMs), som omfattede enten M41L - eller L210W- reverse transkriptase - mutation, viste reduceret respons over for behandlingen med tenofovirdisoproxil 245 mg (som fumarat).
The results indicate that patients whose HIV expressed 3 or more thymidine-analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced response to tenofovir disoproxil 245 mg (as fumarate) therapy.
Kliniske resultater:
Clinical results:
Den gavnlige effekt af tenofovirdisoproxilfumarat hos tidligere behandlede og behandlingsnaive HIV- 1- inficerede voksne er blevet påvist i forsøg af 48 ugers varighed.
The effects of tenofovir disoproxil fumarate in treatment-experienced and treatment-naïve HIV-1 infected adults have been demonstrated in trials of 48 weeks duration in treatment-experienced HIV-1 infected adults.
I undersøgelse GS- 99- 907 blev 550 behandlingserfarne patienter behandlet med placebo eller tenofovirdisoproxil 245 mg (som fumarat) i 24 uger.
In study GS-99-907, 550 treatment-experienced patients were treated with placebo or tenofovir disoproxil 245 mg (as fumarate) for 24 weeks.
Det gennemsnitlige CD4- celletal ved baseline var 427 celler/ mm3, den gennemsnitlige plasmakoncentration af HIV- 1- RNA ved baseline var 3, 4 log10 kopier/ ml (78% af patienterne havde en virusmængde på < 5. 000 kopier/ ml) og den gennemsnitlige varighed af forudgående HIV- behandling var 5, 4 år.
The mean baseline CD4 cell count was 427 cells/ mm3, the mean baseline plasma HIV-1 RNA was 3.4 log10 copies/ ml (78% of patients had a viral load of < 5,000 copies/ ml) and the mean duration of prior HIV treatment was 5.4 years.
Genotypeanalyse ved baseline af HIV- isolater fra 253 patienter afslørede, at 94% af patienterne havde HIV- 1- resistensmutationer i forbindelse med nukleosid reverse transkriptasehæmmere, 58% havde mutationer i forbindelse med proteasehæmmere og 48% havde mutationer i forbindelse med non- nukleosid reverse transkriptasehæmmere.
Baseline genotypic analysis of HIV isolates from 253 patients revealed that 94% of patients had HIV-1 resistance mutations associated with nucleoside reverse transcriptase inhibitors, 58% had mutations associated with protease inhibitors and 48% had mutations associated with non-nucleoside reverse transcriptase inhibitors.